Clinical trials are the gateway to scientific advancements for medication treatments in humans. Since the mid-20th century, all trials of novel medications, including those used in orthopedic subspecialties, have had to adhere to regulations from the US Food and Drug Administration. Though many hybrid and adaptive models of clinical trials abound, the conventional clinical trial is split into four phases with a newer, and optional, preceding exploratory phase. The central tenet of the clinical trial process is to ensure the safety of trial participants and each phase is designed to assess different aspects of safety in addition to specific objectives. Sponsors of medication trials (i.e., pharmaceutical companies) file for approval from the Food and Drug Administration following the successful completion of Phase 3 trials. Evaluation of the medical treatment continues in Phase 4 as investigators examine less common side effects and drug effectiveness in a "real-world" context. The entire clinical trial process spans 10 to 15 years from discovery to drug registration and is associated with additional challenges, namely cost and difficulty in recruiting and retaining participants.

For many years, the new drug application (NDA) has required that every new drug be approved before commercialization in the United States. The purpose of the NDA is to determine the efficacy and safety of new drugs. The NDA is also responsible for determining whether the benefits of the drug outweigh the risks, whether the drug has appropriate labeling, and whether the methods used to manufacture the drug result in a safe, reliable product. Whenever there is an investigational new drug (IND), the data gathered from the associated animal studies and human clinical studies become part of the NDA.

Purpose: To evaluate the outcomes of arthroscopic superior capsular reconstruction (SCR) and arthroscopy-assisted lower trapezius tendon transfer (LTT) for posterosuperior irreparable rotator cuff tears (IRCTs).Methods: Over an almost 6-year period (October 2015 to March 2021), all patients who underwent IRCT surgery with a minimum 12-month follow-up period were identified. For patients with a substantial active external rotation (ER) deficit or lag sign, LTT was preferentially selected. Patient-reported outcome scores included the visual analog scale (VAS) pain score, strength score, American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score, Single Assessment Numeric Evaluation (SANE) score, and Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score. Results: We included 32 SCR patients and 72 LTT patients. Preoperatively, LTT patients had more advanced teres minor fatty infiltration (0.3 vs 1.1, P = .009), a higher global fatty infiltration index (1.5 vs 1.9, P = .035), and a higher presence of the ER lag sign (15.6% vs 48.6%, P < .001). At a mean follow-up of 2.9 +/- 1.3 years (range, 1.0-6.3 years), no differences in patient-reported outcome scores were observed. Postoperatively, SCR patients had a lower VAS score (0.3 vs 1.1, P = .017), higher forward elevation (FE) (156 degrees vs 143 degrees, P = .004), and higher FE strength (4.8 vs 4.5, P = .005) and showed greater improvements in the VAS score (6.8 vs 5.1, P = .009), FE (56 degrees vs 31 degrees, P = .004), and FE strength (1.0 vs 0.4, P < .001). LTT patients showed greater improvement in ER (17 degrees vs 29 degrees, P = .026). There was no statistically significant between-cohort difference in complication rate (9.4% vs 12.5%, P = .645) or reoperation rate (3.1% vs 10%, P = .231).Conclusions: With adequate selection criteria, both SCR and LTT provided improved clinical outcomes for posterosuperior IRCTs. Additionally, SCR led to better pain relief and restoration of FE whereas LTT provided more reliable improvement in ER.Level of evidence: Level III, treatment study with retrospective cohort comparison.

Background:Ganglion cysts are benign soft-tissue tumors that are most commonly found in the wrist. Within the wrist, 60% to 70% of ganglion cysts occur on the dorsal side and 20% to 30% occur on the volar side1. Although ganglia arise from multiple sites over the dorsal wrist, dorsal ganglia most commonly originate at the scapholunate joint2,3. Open excision is the standard surgical treatment for dorsal wrist ganglia. This procedure is considered when symptoms such as pain and range-of-motion deficits begin to impact activities of daily living. Description:Open excision of a dorsal wrist ganglion is commonly performed with the patient under general anesthesia or a regional block. The patient is placed in the supine position, and a tourniquet is applied on the affected upper limb. After outlining the periphery of the palpable ganglion, the surgeon makes a transverse or longitudinal incision over the ganglion. The surgeon then begins a deep dissection, dissecting through the subcutaneous tissue and isolating the ganglion while avoiding any rupture, if possible. Once the cyst has been identified, extensor tendons surrounding the cyst are retracted and the cyst and stalk are mobilized. The cyst and stalk are subsequently excised, and the wound is closed4. Alternatives:Alternative treatments for dorsal wrist ganglia include nonoperative interventions such as observation, aspiration, controlled rupture, and injection. Operative treatments include arthroscopic and open dorsal wrist ganglion resections. Rationale:Although nonoperative treatment can produce successful outcomes, the various modalities have been associated with recurrence rates ranging from 15% to 90%4. As a result, surgical excision remains the gold standard of treatment and is typically indicated when weakness, pain, and limited range of motion interfere with activities of daily living. Among surgical interventions, arthroscopic excision is a minimally invasive procedure that has become more common because of the reduced scarring and faster recovery5. However, open excision, which does not involve complex equipment, is regarded as the standard among surgical treatments. Although the rates of recurrence for arthroscopic versus open dorsal ganglion excision are similar, arthroscopic excision is less effective with regard to pain relief5,6. This difference in pain relief could potentially be the result of the neurectomy of the posterior interosseous nerve in an open excision. In contrast, an arthroscopic procedure may provide less relief of pain from the posterior interosseous nerve stump attaching to the scarred capsule5. Expected Outcomes:Open excision of a dorsal wrist ganglion is a safe, reliable procedure. The recurrence rate after open excision is similar to that after arthroscopic excision and significantly lower recurrence than that after ganglion cyst aspiration6,7. Additionally, not all ganglion cysts can be aspirated. In a retrospective study assessing the risk of recurrence after open excision of ganglion cysts in 628 patients, researchers reported a recurrence rate of 4.1% among the 341 who underwent open dorsal ganglion excision. Furthermore, the authors reported male sex and less surgeon experience as significant risk factors for cyst recurrence8. In a study assessing outcomes of open dorsal ganglion excision in 125 active-duty military personnel, researchers reported a recurrence rate of 9%. More notably, the researchers found persistent pain at 4 weeks postoperatively in 14% of the participants. The authors recommended that patients whose daily activities require forceful wrist extension, such as athletes and military personnel, should be counseled on the potential functional limitations and residual pain from open dorsal wrist ganglion excision9. Important Tips:When conducting an open excision, it is beneficial to identify the stalk of the cyst, allowing the surgeon to excise the complete ganglion complex and prevent recurrence.For large cysts that adhere to the surrounding soft tissue, it is helpful to rupture the ganglion in order to facilitate an easier deep dissection.Excising the scapholunate interosseous ligament could possibly lead to scapholunate dissociation and instability.The posterior interosseous nerve courses past the 4th dorsal compartment and may be resected during the deep dissection.

BACKGROUND: While many current and aspiring neurosurgeons are looking to supplement their clinical practices with leadership positions, there has not been research characterizing current leadership positions such as fellowship directors (FDs) in neurosurgery to provide insight into objective qualities that distinguish these individuals from the rest of the workforce. This study aims to outline the current characterization of spine, endovascular, pediatric, and stereotactic and functional neurosurgery fellowship directors.METHODS: A list of accredited neurosurgical fellowship programs located within the US and their respective directors was acquired through the AANS Neurosurgical Fellowship Training Program Directory. This study obtained educational, demographic, institutional, research, and professional background variables through curriculum vitae, institutional profiles, personal websites, emails, and the Scopus database.RESULTS: Of the 152 FDs analyzed, 143 (94%) were male, 9 (6%) were female, and the mean age was 52.2±8.5 years. The mean Scopus H-index and mean total citations for all FDs was 27±15.7 and 3782.1±4526.7, respectively. Furthermore, the majority of FDs were Caucasian (69.1%), followed by Asian (20.4%), Black or African American (5.3%), and Hispanic or Latino (5.3%). The mean number of years as FD was 8.9±7.2.CONCLUSIONS: This analysis showed neurosurgery fellowship directors are primarily Caucasian males. Neurosurgery training pedigree seems to play a role in FD attainment. In addition, these directors are largely distinguished by their research productivity. This analysis serves as an insight into the current climate for students aspiring to serve as academic leaders in the field of neurosurgery.

Background:Open trigger finger release is an elective surgical procedure that serves as the gold standard treatment for trigger digits. The aim of this procedure is to release the A1 pulley in a setting in which the pulley is completely visible, ultimately allowing the flexor tendons that were previously impinged on to glide more easily through the tendon sheath. Although A1-or the first annular pulley-is the site of triggering in nearly all cases, alternative sites include A2, A3, and the palmar aponeurosis(1).Description:Typically, the surgical procedure can be conducted in an outpatient setting and can vary in duration from a few minutes to half an hour. The surgical procedure involves the patient lying in the supine position with the operative hand positioned to the side. A small incision, ranging from 1 to 1.5 cm, is made on the volar side of the hand, just proximal to the A1 pulley in the skin crease in order to minimize scarring. Once the underlying neurovascular structures are exposed, the A1 pulley is released longitudinally at least to the level of the A2 pulley, followed by decompression of the flexor tendons that were previously impinged on. In order to confirm the release, the patient is asked to flex and extend the affected finger. The wound is irrigated and closed once the release is confirmed by both the patient and surgeon.Alternatives:Aside from an open release, trigger finger can be treated nonoperatively with use of splinting and corticosteroid injection. Alternative operative treatments include a percutaneous release, which involves the use of a needle to release the A1 pulley(2). Trigger finger can initially be treated nonoperatively. If unsuccessful, surgical intervention is considered the ultimate remedy(2).Rationale:Because of their efficacious nature, corticosteroid injections are indicated preoperatively, particularly in non-diabetic patients(3). Splinting is often an appropriate treatment option in patients who wish to avoid a corticosteroid injection(1). However, if nonoperative treatment modalities fail to resolve pain and symptoms, surgical intervention is indicated(2). In comparison with a percutaneous trigger finger release, an open release provides enhanced exposure and may be safer with respect to avoiding iatrogenic neurovascular injury(2). However, in a randomized controlled trial, Gilberts et al. found no difference in the rates of recurrence when comparing open versus percutaneous trigger finger release(4).Expected Outcomes:With reported success rates ranging from 90% to 100%, the open release of the A1 pulley is considered a common procedure associated with minimal complications(2). Complications of the procedure were assessed in a retrospective analysis of 43 patients who underwent 78 open trigger releases performed by 1 surgeon. In that study, the authors reported a minor complication rate of 28% and a major complication rate of 3%(5). Specifically, the 2 major complications noted by the authors were a synovial fistula and a proximal interphalangeal joint arthrofibrosis. In a larger study that included 543 patients who underwent 795 open trigger releases, the authors reported a minor complication rate of 9.6% and major complication rate of 2.4%(6). Furthermore, the most common complications involved persistent stiffness, swelling, or pain. In that analysis, the authors suggested that sedation, male gender, and general anesthesia may be associated with greater risk(6). Important Tips:At the discretion of the surgeon, a longitudinal, transverse, or oblique incision is made directly on top of the tendon at the level of the metacarpophalangeal joint, which is the preferred incision site because it provides maximal accessibility to the A1 pulley.Local anesthesia is preferred because it allows the patient and surgeon to confirm the release immediately.If conducting an open trigger release on the thumb, the surgeon should identify and protect the radial digital nerve, which courses directly over the A1 pulley.Acronyms and Abbreviations:MCP = metacarpophalangeal

Background:An open Achilles tendon repair is performed in patients who have suffered an acute rupture. All patients with this injury should be counseled on their treatment options, which include open operative repair and functional rehabilitation. We prefer the use of an open repair in high-level athletes and those who have delayed presentation. Typically, this injury-and the resulting open repair-are seen in young or middle-aged patients as well as athletes. Operative repair of a ruptured Achilles tendon is associated with a much faster return to activity/sport when compared with nonoperative alternatives. This surgical procedure is especially useful in allowing this patient population to return to their previous activity level and functional capacity as quickly as possible. Description:Open repair of a ruptured Achilles tendon begins with a 6 to 8-cm incision over the posteromedial aspect of the lower leg. Superficial and deep dissections are performed until the 2 ends of the ruptured tendon are identified. Adhesions are debrided to adequately mobilize and define the proximal and distal segments of the tendon. With use of a fiber tape suture, a modified locking Bunnell stitch is utilized to secure both ends. The fiber tape is tied securely, and the repair is reinforced with Vicryl suture (Ethicon). Once the tendon is repaired, the paratenon layer is identified and repaired with a running 0 or 2-0 Vicryl suture. This is an important step to minimize postoperative wound complications. The wound is then closed, and the extremity is splinted in maximum plantar flexion. Alternatives:Alternative treatments include minimally invasive surgical techniques such as percutaneous Achilles tendon repair and nonoperative treatment with functional rehabilitation, which can provide excellent outcomes but can also lead to a slight decrease in explosiveness as the patient returns to sport1,2. Rationale:Nonoperative and operative treatment of Achilles tendon rupture can both result in excellent patient outcomes. Appropriate patient selection is critical. Younger patients hoping to return to more highly competitive athletics should consider operative repair3. Possible differences have been identified in peak torque when comparing operative versus nonoperative treatment, with patients who had undergone operative repair having greater peak torque (i.e., explosiveness)2. Otherwise, findings are similar between treatment options as long as the patients meet the criteria for nonoperative treatment. Expected Outcomes:Overall, the scientific literature demonstrates that the functional outcomes following operative repair are good to excellent. In a study by Hsu et al.4, 88% of patients were able to return to their baseline level of activity by 5 months postoperatively, with a complication rate of 10.6% and no reruptures. In a recent meta-analysis by Meulenkamp et al.5, the authors found that operative repair of Achilles tendon rupture was associated with a reduced risk of rerupture compared with primary immobilization (i.e., conventional cast immobilization with delayed weight-bearing for at least 6 weeks only). However, open surgical repair, minimally invasive repair, and functional rehabilitation all had similar risk of rerupture5. In a review by Ochen et al.6 that analyzed 29 studies with a total of 15,862 patients, operative repair was associated with a significantly lower risk of rerupture compared with nonoperative treatment (2.3% versus 3.9%, respectively). However, operative treatment was also associated with a significantly higher complication rate compared with nonoperative treatment (4.9% versus 1.6%, respectively)6. Finally, in a meta-analysis by Soroceanu et al.7, the authors found that if early range-of-motion protocols and functional rehabilitation were utilized, operative and nonoperative treatment resulted in similar outcomes and equivalent rates of rerupture. Important Tips:To prevent rerupture of an Achilles tendon, remind patients to engage in adequate stretching and warming prior to physical activity.Palpate and locate the tendon defect prior to making the first incision.Immobilize the ankle joint in a splint for 2 weeks postoperatively in maximum plantar flexion.Pitfalls include:○ Poor suture management leading to tangling in the repair.○ Undertensioning or overtensioning of the repair, which can be avoided by sterilely draping out both legs and checking resting tension intraoperatively.○ Failure to close the paratenon, causing scarring of the skin or surrounding tissues, which can be avoided by making a relieving incision on the deep surface of the paratenon.○ Leaving suture knots on the dorsal side of the repair that may aggravate the skin. Acronyms & Abbreviations:MRI = magnetic resonance imagingESU = electrosurgical unit.

Purpose:To investigate the characteristics of shoulder and elbow fellowship directors (FDs). Methods:FDs for shoulder and elbow fellowship programs in the United States were identified. Demographic, educational, and professional background data were collected from available curricula vitarum, institutional biographies, and the Scopus database. Data collected included age, sex, race/ethnicity, training locations, graduation years, advanced degrees, current institutional information, and personal research H-index. Results:Thirty current orthopaedic shoulder and elbow FDs were identified. The mean Scopus H-index was 25.5. The mean age of FDs was 52.1 years. In total, 29 FDs (96.7%) were male and 1 (3.3%) was female. In addition, 25 of the 30 (83.3%) were White (83.3%), 4 were Asian, and 1 (3.3%) was Hispanic. Two (6.7%) had a military affiliation. Mean time from fellowship training graduation to FD appointment was 13.5 years. Mean number of years as FD was 6.1 years, whereas the number of years tenure with an FD-affiliated institution was 13.0 years. Mean calendar years for completion of orthopaedic residency training and fellowship training were 1998 and 2000, respectively. The residencies that produced the most future FDs were Hospital of the University of Pennsylvania (n = 2) and University of Nebraska Medical Center/Creighton University Health Foundation (n = 2). The fellowship that produced the most future FDs was Columbia University (n = 6). Moderate correlation was found between age and Scopus H-index (r = 0.48; P = .04) and years as FD and Scopus H-index (r = 0.42; P = .03). Conclusions:Women and minorities are under-represented in leadership positions in shoulder and elbow surgery. Shoulder and elbow FDs have the highest H-index of any subspecialty reported in the orthopaedic literature. Research productivity is an important qualification when considering the characteristics of shoulder and elbow FDs. Clinical Relevance:Fellowship directors can have a profound influence on current and future orthopaedic surgeons. It is important to identify the traits that characterize current fellowship directors to have a better understanding of who we choose as leaders in our field.

Introduction: The purpose of this study was to determine the objective characteristics of orthopaedic musculoskeletal oncology fellowship directors (FDs) by concentrating on the demographics, academic background, institutional history, research experience, and professional affiliations of these leaders. Methods: Data were collected for each FD through institutional biographies or publicly available curriculum vitae. The data collected for each FD included demographic, professional, and research information. Results: Of the 19 FDs, 15 (78.9%) were male, and 4 (21.1%) were female. The mean age for all FDs was 49.2 ± 9.1 years. Most FDs were White (n = 16; 84.2%). The mean Scopus H-index, total number of citations, and total number of publications among all 19 FDs were 21.6 ± 13.8, 2,290.6 ± 2,709.0, and 84.0 ± 54.7, respectively. The mean number of years serving in the FD role was 7.1 ± 9.1 years, and the mean number of years that the FD was employed at his/her current institution was 11.1 ± 8.1 years. Conclusion: This study shows that orthopaedic musculoskeletal oncology FDs were mainly White (84.2%), male (78.9%), and in their late 40s; have filled their role as FD for an average of 7.1 years; and are very productive in research.

PURPOSE:To determine the objective characteristics of fellowship directors (FDs) in orthopaedic sports medicine by focusing on the demographics, academic background, institutional history, research experience, and professional affiliations of FDs in this field.METHODS:Data was collected for each FD via institutional biographies or publicly available curriculum vitae (CV). The data collected for each FD included age, gender, race/ethnicity, previous training institutions, residency and fellowship graduation years, additional advanced degrees, military affiliation, institutional loyalty, year hired by current institution, career timeline, Scopus H-index, number of publications, and total number of citations.RESULTS:Of the 88 FDs, 87 (98.9%) were male and 1 (1.1%) was female. The mean age for all FDs was 54.7 years (± 9.1 standard deviation). The majority of FDs were White (n = 80; 90.9%). The mean Scopus H-index, total number of publications, and total number of citations were 22.5 ± 16.6, 90.0 ± 91.6, and 2773.9 ± 3962.9, respectively. On average, it took 9.5 ± 7.3 years from fellowship graduation until FD appointment. Additionally, the mean number of years of employment or affiliation with the current institution was 17.2 ± 9.4, and the mean number of years in an FD role was 10.9 ± 9.3.CONCLUSION:Orthopaedic sports medicine fellowship directors are largely distinguished by their high level of research productivity and accomplishment. Additionally, orthopaedic training pedigree seems to play a role in FD role attainment, with a handful of orthopaedic residency and sports medicine fellowship programs producing a large percentage of current FDs. Finally, FDs are overwhelmingly white males with little female or minority representation.CLINICAL RELEVANCE:This study outlines some of the most important characteristics among orthopaedic sports medicine fellowship directors and identifies racial and gender disparities within this population of leaders that may have detrimental effects on the field as a whole.

PURPOSE:To determine the objective characteristics of orthopaedic foot and ankle fellowship directors (FDs) by concentrating on the demographic characteristics, academic background, institutional history, research experience, and professional affiliations of these leaders.METHODS:Data for each FD were collected by searching institutional biographies, personal websites, or publicly available curricula vitae. Data collection included the following variables: age, sex, race/ethnicity, previous training institutions, residency and fellowship graduation years, advanced degrees, military affiliation, institutional loyalty, year hired, FD career timeline, total number of publications, total number of citations, and h-index.RESULTS:Of the 47 FDs, 44 (93.6%) were men and 3 (6.4%) were women. The mean age was 50.8 ± 9.4 years. Most orthopaedic foot and ankle FDs were white (n = 42, 89.4%), followed by Asian (n = 4, 8.5%) and black or African American (n = 1, 2.1%). The mean Scopus h-index, total number of publications, and total number of citations for all foot and ankle FDs were 13.3 ± 9.5, 47.5 ± 45.8, and 898.1 ± 1,040.3, respectively. Among all foot and ankle FDs, the mean tenure in the FD position was 5.8 ± 4.6 years.CONCLUSIONS:Orthopaedic foot and ankle FDs are primarily white men in their 50s, with minimal female and minority representations. These FDs are distinguished by their high level of research productivity. Additionally, orthopaedic foot and ankle training backgrounds seem to play an important role, given that most of the appointed FDs trained in only a few select programs.CLINICAL RELEVANCE:This study outlines some of the most important characteristics among foot and ankle FDs and identifies important disparities within this population of leaders that may have detrimental effects on the field.