BACKGROUND:Dupuytren's contracture produces a progressive flexion contracture of the affected fingers. Collagenase Clostridium histolyticum produces breakdown of the cord in the hand and/or finger(s) that tightens as a result of the disease creating a contracture, allowing manual traction and cord rupture. One of the side effects is spontaneous skin laceration when the finger is extended.OBJECTIVES:To evaluate the development of skin lacerations in Dupuytren's contracture treated with collagenase Clostridium histolyticum, to determine predisposing factors, and evaluate the effectiveness of 2 different treatments (antiseptic and non-antiseptic dressings).PARTICIPANTS:Included 157 patients diagnosed with Dupuytren's contracture and treated with collagenase Clostridium histolyticum.METHODS:Analysis of variables and logistic regression model were applied to determine their possible relationship with skin lacerations. The effectiveness of the type of treatment used was evaluated by comparing the amount of time required for healing.RESULTS:Skin lacerations were present in 33.1% (n = 52) of patients, with an average laceration length of 1.12 (SD: 0.70) cm. Characteristics that were significant predisposing factors for lacerations were disease bilateralism (p = .002), previous surgical intervention (p = .003), and initial matacarpophalangeal joint contracture (p < .001). Worse initial contracture (Z = 5.94; p < .001) had a greater risk of laceration as did those who had prior hand surgery, or whose little finger was affected. Average treatment length of healing was 11.24 days (SD: 8.13). All wounds healed successfully. There were no significant differences (p = .511) in healing between different dressings evaluated.CONCLUSIONS:Skin lacerations as a consequence of treating Dupuytren's contracture with collagenase Clostridium histolyticum occur often and are moderately serious. For all cases, evolution is satisfactory in less than 2 weeks, and the type of treatment does not appear to make any difference in healing time.
Procedural pain is one of the most common adverse effects reported by patients with Dupuytren disease (DD) treated with collagenase clostridium histolyticum (CCH). The aim of this study was to assess the effectiveness of wrist block before CCH injection in reducing procedural pain and to analyze its impact on adverse effects. We performed a prospective, single-center study in which we compared two groups of patients in a consecutive cohort. In the first group (NO-BLOCK), wrist block was only performed before finger extension, whereas in the second group (BLOCK), it was performed before CCH injection and finger extension. Pain was assessed on a 10-item numerical rating scale. Our results show that pain scores were clearlylower in the BLOCK group than in the NO-BLOCK group: 4.72 vs. 0.61 for CCH injection and 3.43 vs. 0.82 for finger extension. Patients who rated CCH injection pain with a score of 4 or higher were 11 times more likely to experience pain during extension. There was a weak correlation between the use of wrist block for CCH injection and the occurrence of skin lacerations (Spearman's rho = -0.222, p < 0.01) and the presence of pruritus (Spearman's rho = 0.183, p < 0.07). In conclusion, wrist block before CCH injection is an effective measure of decreasing perceived pain throughout the different stages of CCH treatment in patients with DD.
PURPOSE:Collagenase Clostridium histolyticum (CCH) is approved for the treatment of adults with Dupuytren contracture with a palpable cord. This open-label, phase 4 study evaluated the safety and efficacy of CCH for the retreatment of recurrent contractures in joints that were previously effectively treated with CCH. METHODS:Patients participating in a long-term follow-up study who had contracture recurrence (increased ≥ 20° with a palpable cord) after successful treatment in the previous study were eligible. Recurrent joint contractures were treated with up to 3 CCH injections (∼ 1 month apart). Patients were followed for 1 year to evaluate safety. Assessments included change in joint contracture, range of motion, and the percentage of joints that achieved contracture of 5° or less at day 30 after the last injection. RESULTS:The efficacy analysis included 51 patients with 1 treated joint per patient (31 metacarpophalangeal, 20 proximal interphalangeal). A total of 35 joints (69%) received 1 injection, 12 (24%) received 2 injections, and 4 (8%) received 3 injections. Fifty-seven percent of joints achieved contracture of 5° or less (29 of 51). Overall, 86% (43 of 50) patients had a 20° or greater increase in range of motion. The adverse event profile was consistent with previous studies. One ligament injury was reported. CONCLUSIONS:At a short-term follow-up of 1 year, recurrent contracture in joints previously successfully treated with CCH may be effectively retreated with up to 3 injections of CCH. TYPE OF STUDY/LEVEL OF EVIDENCE:Therapeutic IV.
PURPOSE:The primary objective of this study was to quantify the degree of pain associated with collagenase Clostridium histolyticum (CCH) injection and to determine whether it is related to other factors in the intervention.METHODS:A prospective study of 135 patients was performed to evaluate pain at 3 points during treatment: (1) after CCH injection, using a numerical rating scale (NRS), (2) a binary (positive/negative) assessment before manipulation 24 hours after CCH and after removing the bandage, and (3) after joint manipulation performed with wrist block anesthesia.RESULTS:The average NRS for pain during infiltration was 4.7. Pain was present before manipulation in 52.6% of patients. Pain from manipulation showed an average NRS score of 3.6. The amounts of pain at CCH infiltration, pain after 24 hours, and pain from the manipulation were correlated because patients who experienced pain during CCH infiltration were more likely to report experiencing pain during manipulation.CONCLUSIONS:Collagenase Clostridium histolyticum injection for treating Dupuytren contracture can be a painful process. There is a clear relationship between a patient's level of pain during injection of CCH and the likelihood that the patient will experience pain during manipulation, even with the use of local anesthesia.TYPE OF STUDY/LEVEL OF EVIDENCE:Prognostic IV.
This paper1Samora J.B. Lifchez S.D. Blazar P.E. the Ethics and Professionalism CommitteePhysician-rating Web sites: ethical implications.J Hand Surg Am. 2015; : 40Google Scholar reports on a survey of American Society for Surgery of the hand members regarding their knowledge, opinions, and the ethics of involvement in physician-rating Web sites (PRWs). Physician-rating Web sites and patient satisfaction reports are both increasingly prevalent and, perhaps, increasingly important for both patient referrals and physicians’ reimbursement. The influence of patients’ satisfaction ratings of hospitals and hospital-based employees has been a topic of conversation for years.2Bacon N. Will doctor rating sites improve standards of care? Yes.BMJ. 2009; 338: b1030Crossref PubMed Scopus (34) Google Scholar, 3Williams B. Patient satisfaction: a valid concept?.Soc Sci Med. 1994; 38: 509-516Crossref PubMed Scopus (847) Google Scholar, 4McCartney M. Will doctor rating sites improve the quality of care? No.BMJ. 2009; 338: b1033Crossref PubMed Scopus (40) Google Scholar We commend the authors on opening a conversation about PRWs’ import and impact for hand surgeons.We are concerned about the reliability of the authors’ conclusions, because only 12% responded to the survey. Were these respondents the most concerned, the most aware, or the previously wounded? It is at least possible that the other 88% of American Society for Surgery of the Hand members have very different opinions and experiences; or perhaps, do not yet have opinions. We, therefore, hesitate to advocate for policy changes based on this very limited sample.Physician-rating Web sites present real challenges, however.5Verhoef L.M. Van de Belt T.H. Engelen L.J. Schoonhoven L. Kool R.B. Social media and rating sites as tools to understanding quality of care: a scoping review.J Med Internet Res. 2014; 16: e56Crossref PubMed Scopus (95) Google Scholar They may risk inducing physicians to give medically unnecessary care in order to satisfy a patient seeking, say, unjustified time off work, and who might otherwise “downgrade” a provider on a PRW. Such negative “public reviews” may dissuade potential patients from seeking that provider. Other, long-established “satisfaction measures” (such as Hospital Consumer Assessment of Healthcare Providers and Systems and Press Ganey, also negatively viewed by respondents) have been shown to have low correlation with actual care quality and/or with increased cost and mortality.6Fenton J.J. Jerant A.F. Bertakis K.D. Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality.Arch Intern Med. 2012; 172: 405-411Crossref PubMed Scopus (611) Google ScholarAssuming that the distribution of opinions among nonrespondents is similar to that of respondents, however, this survey shows that we do not like being rated online and that a few of us have had negative experiences with online rating systems. Interestingly, despite their universally negative perception of PRWs, most survey respondents reported minimal concern about the importance (ie, impact) of these Web sites: 82% of respondents said PRWs had no effect on their practice, and of those 12% who had changed their practice, most had educated staff members (presumably regarding patients’ satisfaction and reporting). We suspect that there would be similar results with a survey about hospital credentialing methods—in that there will always be dissatisfied physicians.Although we caution that the plural of anecdote may be data, it is not “evidence”; the anecdotal reports of specific negative experiences are still important (eg, competitor’s malposting or workers’ compensation cases). They may be the proverbial canary in the coal mine: physicians’ and patients’ satisfaction does matter and is now more easily and widely shared. In addition, willfully misrepresenting the truth is never defensible. But the fact that most patients’ ratings are positive suggests that reviews may not, overall, be as negatively biased as we (might, cynically) suspect.7Lagu T. Hannon N.S. Rothberg M.B. Lindenauer P.K. Patients' evaluations of health care providers in the era of social networking: an analysis of physician-rating websites.J Gen Intern Med. Sep 2010; 25: 942-946Crossref PubMed Scopus (218) Google Scholar, 8Gao G.G. McCullough J.S. Agarwal R. Jha A.K. A changing landscape of physician quality reporting: analysis of patients' online ratings of their physicians over a 5-year period.J Med Internet Res. 2012; 14: e38Crossref PubMed Scopus (254) Google Scholar We believe that the core message should continue to be that simply caring for the patient’s physical needs has never been enough. We must also care for the rest of the patient, and we need to take time to communicate that we do, with action, in deed, and in taking time to listen.Many rightfully criticize our profession for not addressing or meeting our patients’ needs. A few studies have actually shown some correlation between patient satisfaction and quality of care.9Woolley F.R. Kane R.L. Hughes C.C. Wright D.D. The effects of doctor-patient communication on satisfaction and outcome of care.Soc Sci Med. 1978; 12: 123-128PubMed Google Scholar, 10Greaves F. Pape U.J. King D. et al.Associations between Web-based patient ratings and objective measures of hospital quality.Arch Intern Med. 2012; 172: 435-436Crossref PubMed Scopus (77) Google Scholar, 11Manary M.P. Boulding W. Staelin R. Glickman S.W. The patient experience and health outcomes.N Engl J Med. 2013; 368: 201-203Crossref PubMed Scopus (516) Google Scholar Interestingly, some work also shows similarities between the issues mentioned in Yelp reviews and the domains on the Hospital Consumer Assessment of Healthcare Providers and Systems survey.12Kilaru A.S. Meisel Z.F. Paciotti B. et al.What do patients say about emergency departments in online reviews? A qualitative study [published online ahead of print July 24 2015].BMJ Qual Saf. 2015; http://dx.doi.org/10.1136/bmjqs-2015-004035PubMed Google Scholar We know from our own experience that there is an important need for the patient’s understanding and engagement in care, but is that more so than with other specialties?Ultimately, as the authors acknowledge, PRWs (and the realities of Trip Advisor) are here to stay. We can bemoan their invention, or we can learn to work with them. The authors have not given us solutions. Their call to action, we believe, is their highlighting of the specialties and medical societies that have begun to promote standards for accuracy in reporting sites and programs. We agree strongly that our professional societies should prioritize active engagement for these activities. Individually, as a specialty society, and in our practice groups, we also recommend that practitioners:-Become active in social media, including Yelp, Instagram, Twitter (do you tweet?)13Choo E.K. Ranney M.L. Chan T.M. et al.Twitter as a tool for communication and knowledge exchange in academic medicine: a guide for skeptics and novices.Med Teach. 2015; 37: 411-416Crossref PubMed Scopus (143) Google Scholar, Facebook, and others. Online, patients both bemoan a lack of communication with their providers and welcome digitally engaged providers with open arms. For the curious, we recommend that you check out “tweetchats” like #hcldr and #hcsm! But, if you need help, there are always other (ie, younger) doctors and professionals who can assist you and your practice group (although anyone with a teenager has an expert already in-house: go for the parent/child bonding time if not for help).-Become active to combat specific inaccuracies in PRWs and develop the ability for redress.-Become an advocate to advance ethical guidelines for physicians’ practice involvement in PRWs (eg, requiring patients to sign a nondisclosure waiver, hiring an on-line firm to “clean” or fluff your reviews, or providing payment for a review are obviously unethical, but asking patients to provide a review is not unethical, and acting to acknowledge patients’ concerns and sources of dissatisfaction can be a positive practice).14Strech D. Ethical principles for physician rating sites.J Med Internet Res. 2011; 13: e113Crossref PubMed Scopus (45) Google Scholar, 15Azu M.C. Lilley E.J. Kolli A.H. Social media, surgeons, and the Internet: an era or an error?.Am Surg. 2012; 78: 555-558PubMed Google Scholar-Consider developing or using already marketed satisfaction measures that better capture the quality of care that we provide.Teddy Roosevelt’s advice may well still be best: “People do not care how much you know until they know how much you care.” What we need to do is adapt that to 21st century communication methods. This paper1Samora J.B. Lifchez S.D. Blazar P.E. the Ethics and Professionalism CommitteePhysician-rating Web sites: ethical implications.J Hand Surg Am. 2015; : 40Google Scholar reports on a survey of American Society for Surgery of the hand members regarding their knowledge, opinions, and the ethics of involvement in physician-rating Web sites (PRWs). Physician-rating Web sites and patient satisfaction reports are both increasingly prevalent and, perhaps, increasingly important for both patient referrals and physicians’ reimbursement. The influence of patients’ satisfaction ratings of hospitals and hospital-based employees has been a topic of conversation for years.2Bacon N. Will doctor rating sites improve standards of care? Yes.BMJ. 2009; 338: b1030Crossref PubMed Scopus (34) Google Scholar, 3Williams B. Patient satisfaction: a valid concept?.Soc Sci Med. 1994; 38: 509-516Crossref PubMed Scopus (847) Google Scholar, 4McCartney M. Will doctor rating sites improve the quality of care? No.BMJ. 2009; 338: b1033Crossref PubMed Scopus (40) Google Scholar We commend the authors on opening a conversation about PRWs’ import and impact for hand surgeons. We are concerned about the reliability of the authors’ conclusions, because only 12% responded to the survey. Were these respondents the most concerned, the most aware, or the previously wounded? It is at least possible that the other 88% of American Society for Surgery of the Hand members have very different opinions and experiences; or perhaps, do not yet have opinions. We, therefore, hesitate to advocate for policy changes based on this very limited sample. Physician-rating Web sites present real challenges, however.5Verhoef L.M. Van de Belt T.H. Engelen L.J. Schoonhoven L. Kool R.B. Social media and rating sites as tools to understanding quality of care: a scoping review.J Med Internet Res. 2014; 16: e56Crossref PubMed Scopus (95) Google Scholar They may risk inducing physicians to give medically unnecessary care in order to satisfy a patient seeking, say, unjustified time off work, and who might otherwise “downgrade” a provider on a PRW. Such negative “public reviews” may dissuade potential patients from seeking that provider. Other, long-established “satisfaction measures” (such as Hospital Consumer Assessment of Healthcare Providers and Systems and Press Ganey, also negatively viewed by respondents) have been shown to have low correlation with actual care quality and/or with increased cost and mortality.6Fenton J.J. Jerant A.F. Bertakis K.D. Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality.Arch Intern Med. 2012; 172: 405-411Crossref PubMed Scopus (611) Google Scholar Assuming that the distribution of opinions among nonrespondents is similar to that of respondents, however, this survey shows that we do not like being rated online and that a few of us have had negative experiences with online rating systems. Interestingly, despite their universally negative perception of PRWs, most survey respondents reported minimal concern about the importance (ie, impact) of these Web sites: 82% of respondents said PRWs had no effect on their practice, and of those 12% who had changed their practice, most had educated staff members (presumably regarding patients’ satisfaction and reporting). We suspect that there would be similar results with a survey about hospital credentialing methods—in that there will always be dissatisfied physicians. Although we caution that the plural of anecdote may be data, it is not “evidence”; the anecdotal reports of specific negative experiences are still important (eg, competitor’s malposting or workers’ compensation cases). They may be the proverbial canary in the coal mine: physicians’ and patients’ satisfaction does matter and is now more easily and widely shared. In addition, willfully misrepresenting the truth is never defensible. But the fact that most patients’ ratings are positive suggests that reviews may not, overall, be as negatively biased as we (might, cynically) suspect.7Lagu T. Hannon N.S. Rothberg M.B. Lindenauer P.K. Patients' evaluations of health care providers in the era of social networking: an analysis of physician-rating websites.J Gen Intern Med. Sep 2010; 25: 942-946Crossref PubMed Scopus (218) Google Scholar, 8Gao G.G. McCullough J.S. Agarwal R. Jha A.K. A changing landscape of physician quality reporting: analysis of patients' online ratings of their physicians over a 5-year period.J Med Internet Res. 2012; 14: e38Crossref PubMed Scopus (254) Google Scholar We believe that the core message should continue to be that simply caring for the patient’s physical needs has never been enough. We must also care for the rest of the patient, and we need to take time to communicate that we do, with action, in deed, and in taking time to listen. Many rightfully criticize our profession for not addressing or meeting our patients’ needs. A few studies have actually shown some correlation between patient satisfaction and quality of care.9Woolley F.R. Kane R.L. Hughes C.C. Wright D.D. The effects of doctor-patient communication on satisfaction and outcome of care.Soc Sci Med. 1978; 12: 123-128PubMed Google Scholar, 10Greaves F. Pape U.J. King D. et al.Associations between Web-based patient ratings and objective measures of hospital quality.Arch Intern Med. 2012; 172: 435-436Crossref PubMed Scopus (77) Google Scholar, 11Manary M.P. Boulding W. Staelin R. Glickman S.W. The patient experience and health outcomes.N Engl J Med. 2013; 368: 201-203Crossref PubMed Scopus (516) Google Scholar Interestingly, some work also shows similarities between the issues mentioned in Yelp reviews and the domains on the Hospital Consumer Assessment of Healthcare Providers and Systems survey.12Kilaru A.S. Meisel Z.F. Paciotti B. et al.What do patients say about emergency departments in online reviews? A qualitative study [published online ahead of print July 24 2015].BMJ Qual Saf. 2015; http://dx.doi.org/10.1136/bmjqs-2015-004035PubMed Google Scholar We know from our own experience that there is an important need for the patient’s understanding and engagement in care, but is that more so than with other specialties? Ultimately, as the authors acknowledge, PRWs (and the realities of Trip Advisor) are here to stay. We can bemoan their invention, or we can learn to work with them. The authors have not given us solutions. Their call to action, we believe, is their highlighting of the specialties and medical societies that have begun to promote standards for accuracy in reporting sites and programs. We agree strongly that our professional societies should prioritize active engagement for these activities. Individually, as a specialty society, and in our practice groups, we also recommend that practitioners:-Become active in social media, including Yelp, Instagram, Twitter (do you tweet?)13Choo E.K. Ranney M.L. Chan T.M. et al.Twitter as a tool for communication and knowledge exchange in academic medicine: a guide for skeptics and novices.Med Teach. 2015; 37: 411-416Crossref PubMed Scopus (143) Google Scholar, Facebook, and others. Online, patients both bemoan a lack of communication with their providers and welcome digitally engaged providers with open arms. For the curious, we recommend that you check out “tweetchats” like #hcldr and #hcsm! But, if you need help, there are always other (ie, younger) doctors and professionals who can assist you and your practice group (although anyone with a teenager has an expert already in-house: go for the parent/child bonding time if not for help).-Become active to combat specific inaccuracies in PRWs and develop the ability for redress.-Become an advocate to advance ethical guidelines for physicians’ practice involvement in PRWs (eg, requiring patients to sign a nondisclosure waiver, hiring an on-line firm to “clean” or fluff your reviews, or providing payment for a review are obviously unethical, but asking patients to provide a review is not unethical, and acting to acknowledge patients’ concerns and sources of dissatisfaction can be a positive practice).14Strech D. Ethical principles for physician rating sites.J Med Internet Res. 2011; 13: e113Crossref PubMed Scopus (45) Google Scholar, 15Azu M.C. Lilley E.J. Kolli A.H. Social media, surgeons, and the Internet: an era or an error?.Am Surg. 2012; 78: 555-558PubMed Google Scholar-Consider developing or using already marketed satisfaction measures that better capture the quality of care that we provide. Teddy Roosevelt’s advice may well still be best: “People do not care how much you know until they know how much you care.” What we need to do is adapt that to 21st century communication methods. Physician-Rating Web Sites: Ethical ImplicationsJournal of Hand SurgeryVol. 41Issue 1PreviewTo understand the ethical and professional implications of physician behavior changes secondary to online physician-rating Web sites (PRWs). Full-Text PDF
Peimer et al. haben die Sicherheit einer Behandlung der Dupuytren-Kontraktur mit Kollagenase aus Clostridium histolyticum (CCH) mit der einer Fasziektomie verglichen. In die Auswertung flossen Daten zu unerwünschten Ereignissen von 11 klinischen Studien zu einer Kollagenasebehandlung ein. Bei den Untersuchungen handelte es sich um eine Phase-I-, eine Phase-IIund 9 Phase-III-Studien mit insgesamt 1082 Patienten. Diesen Daten wurden die Ergebnisse 48 europäischer Studien zu offenen Verfahren seit dem Jahr 1980 – bestehend aus totaler, partieller und Knotensowie Dermofasziektomie – gegenübergestellt. Ausgeschlossen wurden chirurgische Fasziotomie und Nadelaponeurektomie. Die operationsbedingten Komplikationenwurden evaluiert undmit den behandlungsbedingten unerwünschten Ereignissen (AE) der Kollagenase-Studien verglichen. Da die Rohdaten der Fasziektomie-Studien nicht zugänglich waren, erfolgte lediglich eine deskriptive statistische Auswertung. Die FasziektomieStudien umfassten insgesamt 7727 Patienten.
Kilaru et al 1 report a well-designed and well-executed, retrospective, qualitative study, which suggests that one-third of online (Yelp-sourced) patients’ hospital reviews address care in emergency departments (EDs). Using strong qualitative methods, the authors describe the themes emerging from Yelp users’ free-text ED reviews. Some of these themes—communication with nurses, communication with doctors and pain control—correspond with the categories in the nationally accepted US Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. Other themes—waiting and efficiency, decisions to seek care in the ED and the events following discharge—differ from HCAHPS’ domains. These findings are unlikely to surprise those working in an ED, although the report that the majority of comments are positive may be less expected. This publication makes a useful contribution to the field of patient safety and satisfaction in several ways. First, it may inform future efforts to obtain patients’ feedback on their satisfaction with emergency services. As the authors note, the Center for Medicare and Medicaid Services is currently developing an ED-based version of HCAHPS. We hope that some of the ED-specific themes identified in this paper—which, importantly, match the correlates of ED-related satisfaction and …
Fazit Fünf Jahre nach erfolgreicher CCH-Therapie sind noch 53 % der Patienten dauerhaft erfolgreich behandelt. Dies ist vergleichbar mit den Therapieergebnissen nach chirurgischer Behandlung. Nur eine einzige therapiebezogene Nebenwirkung wurde berichtet. CCH-Injektionen sind somit eine wirksame und sichere Therapie der Dupuytren-Kontraktur.
Recurrent Dupuytren's contracture is common regardless of the initial intervention. Collagenase clostridium histolyticum (CCH) is approved for treatment of adult patients with Dupuytren's contracture with a palpable cord. This study assessed safety and efficacy of CCH for the retreatment of recurrent contractures in joints that were previously effectively treated with CCH.
Safety was evaluated for collagenase Clostridium histolyticum (CCH) based on 11 clinical trials ( N = 1082) and compared with fasciectomy data in a structured literature review of 48 European studies ( N = 7727) for treatment of Dupuytren’s contracture. Incidence of adverse events was numerically lower with CCH vs. equivalent complications from fasciectomy (median [range] incidence), including nerve injury (0% vs. 3.8% [0%−50+%]), neurapraxia (4.4% vs. 9.4% [0%−51.3%]), complex regional pain syndrome (0.1% vs. 4.5% [1.3%−18.5%]) and arterial injury (0% vs. 5.5% [0.8%−16.5%]). Tendon injury (0.3% vs. 0.1% [0%−0.2%]), skin injury (16.2% vs. 2.8% [0%−25.9%]) and haematoma (77.7% vs. 2.0% [0%−25%]) occurred at a numerically higher incidence with CCH than surgery. Adverse events in CCH trials not reported after fasciectomy included peripheral oedema; extremity pain; injection site pain, haemorrhage and swelling; tenderness; pruritus and lymphadenopathy. CCH-related adverse events were reported as predominantly injection-related and transient. These results may support clinical decision-making for treatment of Dupuytren’s contracture.
Multiple operations have been proposed to slow the progression of osteonecrosis and secondary carpal damage in Kienböck's disease. To assess the biomechanical changes after capitate shorting, we inserted pressure-testing devices into the carpal and radiocarpal joints in an anatomical study. Pressure sensors were placed into eight thawed non-fixated human cadaver arms to measure the forces transmitted in physiological loading. Longitudinal 9.8 N and 19.6 N forces were applied before and after capitate shortening. After capitate shortening, significant load reduction on the lunate was evident in all specimens. An average decrease of 49% was seen under a 9.8 N load and 56% under a 19.6 N load. The load was transferred to the radial and ulnar intercarpal joints. More relief of pressure on the lunate after isolated capitate shortening is achieved with a shallow angle between the scaphoid and capitate in the posteroanterior radiograph.
Adverse events (AEs) observed after the approval of collagenase Clostridium histolyticum (CCH) (XIAFLEX and XIAPEX) are similar to those observed in the first year of postmarketing surveillance.
Fazit Nach Ergebnissen der Studie kam es im Verlauf von 3 Jahren etwa bei einem Drittel der erfolgreich behandelten Gelenke wieder zum Rezidiv. Die Autoren betonen, dass diese Rezidivrate vergleichbar mit anderen Standardbehandlungen beim Morbus Dupuytren ist. Nur teilweise korrigierte Kontrakturen verschlechterten sich in der Hälfte der Fälle. Zwar kam es häufig zur Bildung spezifischer Antikörper; systemisch-allergische Reaktionen traten jedoch auch bei erneuten Injektionen nicht auf.
Treating Dupuytren contracture with collagenase Clostridium histolyticum (CCH) shows a sustained durability of response in most subjects.
Background Collagenase Clostridium histolyticum (CCH), recently approved in Europe is an efficacious, minimally invasive, and well tolerated treatment for Dupuytren’s contracture (DC). Objectives To report efficacy/safety and recurrence rates 3 years after CCH treatment from the ongoing, 5-year follow-up CORDLESS study of DC patients who participated in Phase III trials of CCH and had ≥1 fixed-flexion contracture (FFC) measurement. Methods CORDLESS enrolled DC patients from all 5 Phase III studies of CCH. Patients were evaluated annually for recurrence starting 2 years after CCH injection. Detailed history, examinations, additional treatments for DC and complications were recorded. Recurrence was defined as: (1) increase in contracture ≥20° and a palpable cord or (2) the joint received further CCH/surgical treatment. A post hoc analysis defined recurrence as a ≥30° increase in joint contracture, a commonly used clinical threshold for secondary surgical intervention. Recurrence by baseline disease severity was also calculated. Low severity was defined as FFC ≤50° for metacarpophalangeal (MP) joints and ≤40° for proximal interphalangeal (PIP) joints, and high severity was defined as FFC >50° for MP and >40° for PIP joints. Results 602 patients (84% male, mean±SD age, 66±9 y) were evaluable at Year 3. Of 1080 treated joints, 623 (58%) achieved clinical success (FFC of affected joint improved to 0-5°). By Year 3, 35% (217/623) of successfully treated joints had recurrence (≥20°), in 27% (120/451) of MP and 56% (97/172) of PIP joints. By Year 3, 22% met the ≥30° definition of recurrence; rates were 16% in MP joints and 38% in PIP joints. In successfully treated joints, lower baseline severity was associated with lower recurrence rates in PIP (50% low vs 71% high) but not in MP joints (28% low vs 18% high). Mean FFC for nonrecurring joints (MP 2.8°; PIP 7.8°) was nearly the same as mean FFC at time of initial success (MP 1.2°; PIP 1.7°). Mean FFC for the recurrent joints at Year 3 (MP 32.8°; PIP 36.7°) was below the pretreatment levels (MP 36.5°; PIP, 40.1°). About 7% of joints underwent CCH treatment or surgical intervention for recurrence by Year 3. No new long-term adverse events (AEs) or serious AEs related to previous CCH treatment were observed. Conclusions CCH is efficacious and well tolerated in DC patients 3 years after initial treatment, and treatment response is durable. Using ≥20° and ≥30° definitions, overall recurrence rate by Year 3 was 35% and 22%, respectively. Recurrence was more common in PIP than MP joints, consistent with published surgical literature. Less severe PIP contracture at baseline resulted in better outcomes. The absence of new or serious AEs at indicates a good long-term tolerability profile for CCH. Disclosure of Interest M. Boeckstyns: None Declared, D. Boyce: None Declared, J. Vasenius: None Declared, F. T. Kaplan: None Declared, C. Peimer: None Declared, P. Blazar: None Declared, D. Gilpin: None Declared, T. Smith Employee of: Auxilium Pharmaceuticals, J. Tursi Employee of: Auxilium Pharmaceuticals, B. Cohen Employee of: Auxilium Pharmaceuticals, P. Szczypa Employee of: Pfizer Ltd, R. Gerber Employee of: Pfizer Inc
Background Dupuytren’s disease is a progressive condition, as the contracture angle and related disease stage often increase with time. Treatment with ≥1 injection of collagenase Clostridium histolyticum (CCH) has been shown to result in a 76% mean reduction in fixed-flexion contracture (FFC): from 50.2° at baseline to 12.2° after CCH in patients with Dupuytren’s contracture (DC).1 Objectives We evaluated whether CCH treatment of early- (ie, palpable cord/1-30° FFC) versus advanced-stage DC (>30° FFC) would result in better outcomes in actual clinical practice. Methods This was a retrospective chart review of DC patients treated with CCH at community and academic practices across the United States (Mar-Dec 2010). Information on patient history and CCH treatment outcomes was collected at each site by physicians or their medically trained staff using a study-specific Case Report Form. Patients who had only 1 CCH-treated joint were included, and outcomes were assessed after the first injection. Results for early- versus advanced-stage DC were compared using t-tests. Results Inclusion criteria were met by 60% (302/501) of patients from 10 sites. On average, patients were aged 66 years; 75% were male. Early- and advanced-stage contractures were observed in 61 and 241 of CCH-treated joints, respectively. Mean ± SD final FFC in CCH-treated joints with early-stage DC (3.8±6.9°) was significantly better than that in CCH-treated joints with advanced-stage DC (14.0±18.0°, p<0.0001). Nonetheless, joints with advanced DC had a significantly greater mean improvement in contracture (43.6±17.9°) versus joints with early DC (20.8±8.0°; p<0.0001). The results were statistically significant even after controlling for joint type (metacarpophalangeal, proximal interphalangeal) in a general linear model. A trend toward a larger mean percent reduction in FFC was observed with early-stage joints (85%) versus advanced-stage joints (78%); however, the difference was not statistically significant after controlling for joint type (p=0.15). No serious adverse events were reported in the study. Conclusions On average, CCH treatment of early-stage DC resulted in a significantly better outcome, to near normal correction, than did treatment of advanced-stage DC. The extent of improvement after CCH was significantly larger in advanced DC likely because of higher baseline severity. This analysis did not assess whether additional CCH injections into advanced-stage joints would result in an equivalent final FFC, or if early treatment abated DC progression or recurrence. These cross-sectional findings favoring early treatment with CCH warrant validation in longitudinal studies. Based on careful assessment of risk-benefit ratio, CCH may provide an additional benefit over surgery, which is usually reserved for more severe cases of DC. References Hurst LC, et al. NEJM 2009;361:968-979 Disclosure of Interest C. Peimer: None Declared, G. Pess: None Declared, P. Skodny Employee of: Auxilium Pharmaceuticals, J. Tursi Employee of: Auxilium Pharmaceuticals, P. Szczypa Employee of: Pfizer Ltd, R. Gerber Employee of: Pfizer Inc
PURPOSE:To collect data on the real-world effectiveness of collagenase clostridium histolyticum (CCH) during its first year of use following U.S. Food and Drug Administration approval and compare those results with clinical trial efficacy data. METHODS:This retrospective chart review was conducted at 10 U.S. community and academic practice sites with major experience using CCH. Charts of patients treated with CCH between February and December 2010 were abstracted, and anonymized data were analyzed. Clinical use, including number of injections per cord and effectiveness outcomes (joint contracture and range of motion) were compared with results from 2 registration trials. RESULTS:Data were collected from 501 patients (74% male; 48% employed; mean [SD] age, 65 [10] y); 463 patients had sufficient data for analysis. We found that 1.08 CCH injections were used per treated joint, compared with a mean of 1.7 injections in registration trials. Ninety-three percent of joints received only 1 injection. The mean (SD) number of visits per injection was 2.92 (1.0). Mean (SD) contracture was reduced by 75% from 49° (21) at baseline to 12° (17), similar to the 71% to 79% reduction in clinical trials. Mean (SD) range of motion was improved by 37° from 44° (20) at baseline to 81° (14), similar to the increase of 35° and 37° in the 2 clinical trials; and 67% of first injections resulted in full correction to 0° to 5°, compared with the clinical trial rate of 39%. CONCLUSIONS:Despite a lower injection rate, correction of joint contracture and range of motion was similar to findings from clinical trials. Effectiveness reports using this kind of surveillance design could provide patients, physicians, and payers with the information needed to make better treatment and reimbursement decisions. TYPE OF STUDY/LEVEL OF EVIDENCE:Therapeutic III.
Objective: To investigate usefulness of osteochondral grafting from the costo-osteochondral junction as a repair technique for articular cartilage defects histologic and biochemical analysis of grafted cartilage in rabbit knees was evaluated up to 48 weeks after transplantation.Methods: Twenty New Zealand White rabbits were used. A costal osteochondral plug was harvested from a middle rib. After trimming, it was transplanted into a cylindrical osteochondral 2.5 mm diameter and 5 mm deep defect created in the knee. The animals were sacrificed at 6, 12, 24, and 48 weeks after transplantation. Defect sites were inspected macroscopically, and then by light microscopy. Samples were evaluated for cell viability using a fluorescent in situ double-staining protocol with confocal laser microscopic analysis. Samples were also processed to assess type I & II collagen and aggrecan mRNA expression using reverse transcription-polymerase chain reaction (RT-PCR).Results: Histologically, bone union was achieved in all plugs. Confocal microscopic analysis revealed chondrocyte viability in the 48-week grafts; the distribution of chondrocytes was similar to surrounding articular cartilage. The expression of type II collagen and aggrecan mRNA in the grafted cartilage was consistent with normal articular cartilage and normal costal cartilage. These results were observed over 6 48 weeks.Conclusions: Our study revealed that chondrocytes in the grafted cartilage were viable at least up to 48 weeks and that mRNA expression of type II collagen and aggrecan was also similar to that of normal articular cartilage. These results suggest that costal osteochondral grafting can be a useful alternative in the treatment of osteochondral defects. (C) 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
Purpose To evaluate long-term efficacy and safety of collagenase clostridium histolyticum (CCH) after the third year of a 5-year nontreatment follow-up study, Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study.Methods This study enrolled Dupuytren contracture patients from 5 previous clinical studies. Beginning 2 years after their first CCH injection, we re-evaluated patients annually for joint contracture and safety. Recurrence in a previously successfully treated joint (success = 0 degrees to 5 degrees contracture after CCH administration) was defined as 20 degrees or greater worsening in contracture in the presence of a palpable cord or medical/surgical intervention to correct new or worsening contracture. We assessed partially corrected joints (joints reduced 20 degrees or more from baseline contracture but not to 0 degrees to 5 degrees) for nondurable response, also defined as 20 degrees or greater worsening of contracture or medical/surgical intervention.Results Of 1,080 CCH-treated joints (648 metacarpophalangeal [MCP]; 432 proximal interphalangeal [PIP]; n = 643 patients), 623 (451 MCP, 172 PIP) had achieved 0 to 5 contracture in the original study. Of these joints, 35% (217 of 623) recurred (MCP 27%; PIP 56%). Of these recurrences, an intervention was performed in 7%. Of the 1,080 CCH-treated joints, 301 were partially corrected in the original study. Of these, 50% (150 of 301; MCP: 38% [57 of 152]; PIP: 62% [93 of 1491) had nondurable response. We identified no new long-term or serious adverse events attributed to CCH during follow-up. Anti-clostridial type I collagenase and/or anti-clostridial type II collagenase antibodies were reported for 96% or more of patients who received 2 or more CCH injections and 82% who received 1 injection.Conclusions The recurrence rate, which is comparable to other standard treatments, and the absence of long-teini adverse events 3 years after initial treatment indicate that CCH is an effective and safe treatment for Dupuytren contracture. Most successfully treated joints had a contracture well below the threshold for surgical intervention 3 years after treatment. Recurrence rates among successfully treated joints were lower than nondurable response rates among partially corrected joints. (J Hand Surg 2013;38A:12-22. Copyright (C) 2013 by the American Society for Surgery of the Hand. All rights reserved.)