A composite inductive allograft consisting of an allogeneic, autolysed, antigen-free cortical bone carrier lyophilized with partially purified human bone morphogenetic protein was implanted in 30 consecutive femoral reconstructions that resulted from failure of fracture healing. There were 24 atrophic shortened femoral nonunions, four equal length femoral nonunions, and two femoral malunions. There were 10 men and 20 women with an average age of 47 years (range, 28-75 years). Allogeneic, autolysed antigen-free cortical bone was used as a structural alloimplant and as a delivery system for partially purified human bone morphogenetic protein. The composite implant of human bone morphogenetic protein/allogeneic, autolysed antigen-free cortical bone was used in conjunction with one-stage lengthening of the extremity, restoration of mechanical axis and rotational alignment. In 26 of 30 femurs, the human bone morphogenetic protein/allogeneic autolysed antigen-free cortical bone consisted of an allogeneic cortical bone implant incorporated into a one-stage lengthening of atrophic femoral nonunion. In four patients with equal length femoral nonunions, the human bone morphogenetic protein/allogeneic, autolysed antigen-free implant was placed as an medial femoral shaft onlay graft. Internal remodeling of the implant occurred within 8 to 12 weeks after implantation. Lengthening defects greater than 2 cm were supplemented with intercalary autogeneic bone graft. Twenty-four femurs healed at an average of 6 months at an average followup of 55 months. Four of six plate fatigue failures were salvaged with repeat plating. Two patients were lost to followup. The human bone morphogenetic protein/allogeneic, autolysed antigen-free bone allograft is an excellent structural and delivery system that induces host bone formation and implant remodeling allowing salvage of difficult femoral nonunions.

Fifteen patients with posttraumatic shortened atrophic femoral nonunions were treated with one-stage lengthening. The alloimplant was composed of allogeneic antigen extracted autolyzed human bone perfused with partially purified human cortical bone morphogenetic protein associated with noncollagenous protein and used as graft. The composite was lyophilized and sterilized with ethylene oxide. All 15 nonunions were atrophic diaphyseal and were lengthened through intercalary segmental defects bridged with the human bone morphogenetic protein composite alloimplants stabilized to the medial femoral cortex through plate osteosynthesis and lag screw fixation. One lengthened proximal femur had fatigue failure of the plate and was treated successfully by exchange plating. The average increase in length was 2.8 cm (range, 1.5-5 cm) and an average percentage increase in length of 8% (range, 4%-132%) of the residual shortened femur. The human bone morphogenetic protein composite produced an immediate reactive bone formation in the host bone and progressive remodeling of the donor recipient interfaces. There were no infections, allergic reactions, clinical rejection of the human bone morphogenetic protein composite alloimplants, or evidence of malignant disease. One-stage femoral lengthening augmented with human bone morphogenetic protein composite graft bridged the intercalary defect, remodeled the atrophic host bone and restored bone continuity within 1 to 2 years. Human bone morphogenetic protein composite alloimplants are a substitute of autogeneic bone graft and offer an alternative to iliac crest bone without the associated morbidity.

Intramedullary nailing of the tibia was performed on 145 tibiae (137 patients) for fracture or nonunion from 1985 to 1992. There were 133 cases available for radiographic analysis of postoperative tibial alignment. Of the 133 nailings, 16 (12%) were malaligned (12 acute fractures and 4 nonunion-malunions). Malalignment was defined as 5 degrees angulatory deformity in any plane. Malalignment was seen in 58% of proximal third fractures, 7% of middle third fractures, and 8% of distal third fractures. Of the malaligned fractures, 83% were either segmental or comminuted. Thirteen percent of the reamed tibiae were malaligned as compared with 9% of the unreamed tibiae. There was no relationship between nail insertion site and degree of angulation. The medial entrance angle averaged 9.5 degrees and contributed to a valgus deformity in 4 proximal third tibial fractures. The average anterior bow deformity of 5 proximal third fractures was 7 degrees (range, 5 degrees-12 degrees). Careful attention to operative technique and entrance angle, particularly with proximal third or comminuted fractures, is recommended to prevent angular deformity and malunion after tibial nailing. Proximal third tibial fractures may require a neutral or slightly lateral entrance angle to ensure a more anatomic reduction and centromedullary nail orientation to offset the tendency for valgus angulation.

Eighty seven patients with 88 fractures were retrospectively reviewed to assess the effect of postoperative prophylaxis on the formation of heterotopic ossification (HO). Sixty eight patients with 69 acetabular fractures were followed for an average of 21 months (range, 3-98 months). The grade of HO was assessed using the Brooker classification system. Thirty four fractures had no prophylactic treatment, 30 were treated prophylactically with indomethacin, two with radiation therapy, and three with both indomethacin and radiation. Twenty (59%) of 34 untreated fractures developed HO, of which nine (26%) were Grade III or IV. Thirteen (43%) of 30 fractures treated with indomethacin developed HO, of which 5 (16%) were Grade III and none were Grade IV. Twenty one of 24 fractures were stabilized through the extended iliofemoral approach; 13 of these had no prophylaxis. Eleven of the 13 developed HO; eight were Grade III or IV (62%). Seven of eight fractures treated with indomethacin following the extended iliofemoral approach developed HO; one was Grade III (13%) and non Grade IV. There was no significant difference between 13 patients who were not treated prophylactically and 18 indomethacin treated patients stabilized through the Kocher-Langenbeck approach. Only one of 11 patients had HO (Grade I) following an ilioinguinal approach. Postoperative radiation therapy, with or without indomethacin, resulted in three patients with Grade 0 HO (all radiated 1-4 days post surgery), one with Grade II (radiated postoperative Day 8), and one with Grade III HO (significant delay in surgery with preoperative Grade III HO of the hip).(ABSTRACT TRUNCATED AT 250 WORDS)

Twelve patients with tibial shaft fractures and evidence of compartment syndrome or with documented elevated compartment pressures were treated with an unreamed locked intramedullary nail and a single-incision lateral four-compartment fasciotomy. There were six closed fractures and three grade I and three grade II open fractures. Ten fractures have achieved a solid union without shortening or significant angulation at an average follow-up of 8.1 months (range 4–26). Two patients were lost to follow-up. There were two delayed unions and one nonunion, all of which healed after additional treatment. Average time to tibial union was 5.8 months (range 2–24), with six fractures healing in < 4 months. One patient whose treatment was delayed >12 h after his injury has a persistent neurologic deficit with a claw toe deformity. There were no superficial or deep infections. All patients obtained an excellent range of motion of the knee and ankle. Unreamed nailing of diaphyseal tibial fractures with an associated compartment syndrome provides optimal internal fixation while allowing excellent access for soft tissue care. We believe that the unreamed tibial nail, when combined with a single-incision, lateral, four-compartment fasciotomy, offers substantial advantage in the treatment of this injury, permitting optimal treatment of a difficult fracture and soft tissue injury.

Fractures of the acetabulum can cause the pelvis to shatter into a wide array of complex configurations which can be difficult to fully delineate preoperatively. In addition to plain radiography and standard computed tomography, technology now allows the reconstruction of magnetic resonance imaging (MRI) and computed tomography (CT) data into virtual objects; three dimensional (3D) representations of anatomy which exist only within the computer memory. Printouts and photographs of 3D reconstructions provide another level of anatomic information to the orthopaedic surgeon. However, current standard displays such as computer and video screens and photographic and radiographic film are all two dimensional (2D) modalities. Displaying 3D reconstructions in this standard 2D fashion, inescapably robs the images of up to one third of the information contained within them-all the true depth information which is the essence of 3D. Shading techniques and perspective have both been utilized to simulate depth, but true depth is still lacking. Recently, the authors have begun using a technique of computerized 3D reconstruction and recording which provides a true 3D display of the reconstructed images. The resultant gain in image realism is profound, somewhat similar to hearing full stereo audiophonic recording compared to monophonic, or to seeing in color rather than black and white. The image generation and display process is a computerized mathematical adaptation of the photographic technique of stereophotography. Once in place, the technique is relatively simple to use and can be achieved in several ways with a minimum of additional hardware. Potential benefits lie in the method's ability to convey, in one 3D display, the true 3D, spatial anatomic configuration of the imaged pelvis. The methods described are common to those forming the fundamental basis for virtual reality imaging. Current users of some 3D reconstruction systems can now easily generate images which can be viewed with all of the depth information restored, into a true 3D display.

Twenty-five patients with resistant nonunions including partial or complete segmental defects were treated with a composite alloimplant of human bone morphogenetic protein (h-BMP) and autolyzed, antigen-free, allogeneic bone (AAA). The series consisted of 16 females and nine males; average age was 45 years. Preoperative symptoms averaged 30 months (range, five to 83 months); 22 of 25 patients had failed multiple attempts at electrical stimulation. Twenty-three of 25 patients had an average of three prior failed surgical attempts at union (range, one to ten). There were ten segmental defects with an average length of 4 cm (range, 2-9 cm). The composite implant was incorporated as an onlay in 15 extremities and as an inlay graft supported by internal fixation in ten extremities. Seven patients received supplementary autogeneic cancellous bone grafting. Average healing time was six months (range, three to 14 months). Average follow-up time was 21 months (range, five to 82 months). Functional results were rated as excellent, 14; good, five; and fair, five. One failed to unite because of a recurrent infection. Union was obtained in 24 of 25 patients. There were five failures of the original operation that required reoperations; union eventually occurred in four of five extremities by repeat composite grafting and replacement of the failed internal fixation. Bony union between host bone and the composite implant began at an average of eight weeks postoperatively. Present results indicate that h-BMP/AAA composite implants represent adjunctive treatment of difficult nonunions. The h-BMP/AAA composite implants may be implanted in either partial or complete segmental defects of long bones.(ABSTRACT TRUNCATED AT 250 WORDS)

Four patients with severely deformed nonunions of the distal end of the tibia failed to respond to standard surgical methods and were successfully treated as follows: debridement of fibrous tissue, sequestrectomy, correction of angulatory deformities, internal stabilization, and implantation of human bone morphogenetic protein (hBMP). After resection of the sequestra, all four patients had significant bone defects of the anterior tibial cortex extending to the ankle joint. The average number of failed previous surgical procedures was 5.8. The average patient age was 35.3 years. The intervals of nonunion averaged 24.8 months. In two patients, the hBMP, including other low molecular weight bone matrix noncollagenous proteins (hBMP/NCP), was implanted across the fracture site in polylactic-polyglycollic acid strips (1 X 13 cm) as an onlay graft. In one patient, the BMP was implanted in the fracture gap in absorbable gelatin (No. 5 capsules). In another patient, the BMP/NCP was also implanted in the form of a composite of cortical allogeneic bone in addition to a capsule of BMP/NCP. In all four cases, alignment was restored and the bone ends were stabilized with internal fixation. Preoperatively, the ankle joints were ankylosed and painful. Healed fractures and functional ankle joints were observed in three of four patients at an average of 4.4 months. In one patient, the fracture healed but the joint remained ankylosed. Although a randomized double-blind consecutive series of matched cases is necessary to prove the efficacy of hBMP, implants of hBMP combined with skillful surgical treatment are under investigation in the interim as an alternative to amputation.

Nonunions or large segmental defects of long bones which have failed multiple surgical and conservative attempts at union are a significant problem and may be resistant to further standard surgical treatment. The implantation of a substance which induces primitive cells in the perinonunion area to undergo an osteogenetic pathway of development may represent a significant change in the management of the resistant nonunion or skeletal defects. This augmentation of the host healing response by the addition of human bone morphogenetic protein (hBMP) to cancellous autogeneic graft is the theoretical postulate used to definitively treat this series of resistant nonunions and skeletal defects.

Xenogeneic (bovine) bone morphogenetic protein (bBMP) and associated insoluble noncollagenous proteins (NCP) were implanted in inbred adult beagle dogs with 3–4 cm diaphyseal defects in the ulna. Defects were stabilized with internal plate fixation, and the control defects were not stabilized. The defects were implanted with either autogeneic cancellous bone grafts (ACG), bBMP/NCP, or a composite of ACG and bBMP/NCP. Of the plated ulnae, 18 of 19 ACG controls restored bone continuity; six of seven defects healed under the influence of bBMP/NCP plus ACG. Two of four defects with bBMP/NCP plus ACG healed and two were filled with osseous tissue, but fibrous tissue developed at one or both bone ends. Eight of nine defects implanted with bBMP/NCP capsules alone were repaired with fibrous tissue only. Of the nonplated defects, four were implanted with bBMP/NCP plus ACG and only one regenerated; three of four showed hypertrophic bone growth around a pseudarthrosis. Of six nonplated defects implanted with bBMP/NCP without ACG, all developed atrophic bone ends and fibrous tissue repair. Thus, to restore continuity of large segmental defects three times greater than the critical size for spontaneous regeneration, xenogeneic bBMP/NCP failed to induce bone regeneration in dogs. To exclude cell-mediated immune reactions and soft-tissue ingrowth, one defect was bridged with a polytetrafluoroethylene semipermeable tube (pore size 0.45 μm) containing implants of bBMP/NCP. In response to bBMP/NCP, cells from the host bone ends produced ossicles of induced woven bone formation. The observation that bBMP/NCP induced bone formation across the defect inside of semipermeable cylindrical chambers suggests that the experiments on bone defects larger than the critical size for spontaneous repair should be repeated with: (1) allogeneic dog BMPINCP; (2) semipermeable cylinders to protect against muscle interposition; (3) compartment angiograms to evaluate blood supply; (4) treatment of the recipient with immunosuppressants and immunostaining to observe the concentration gradient of BMP; and (5) histologic observations on the first three days after implantation to evaluate cell-mediated immune barriers to the response of BMP.

Xenogeneic (bovine) bone morphogenetic protein (bBMP) and associated insoluble noncollagenous proteins (NCP) were implanted in inbred adult beagle dogs with 3-4 cm diaphyseal defects in the ulna. Defects were stabilized with internal plate fixation, and the control defects were not stabilized. The defects were implanted with either autogeneic cancellous bone grafts (ACG), bBMP/NCP, or a composite of ACG and bBMP/NCP. Of the plated ulnae, 18 of 19 ACG controls restored bone continuity; six of seven defects healed under the influence of bBMP/NCP plus ACG. Two of four defects with bBMP/NCP plus ACG healed and two were filled with osseous tissue, but fibrous tissue developed at one or both bone ends. Eight of nine defects implanted with bBMP/NCP capsules alone were repaired with fibrous tissue only. Of the nonplated defects, four were implanted with bBMP/NCP plus ACG and only one regenerated; three of four showed hypertrophic bone growth around a pseudarthrosis. Of six nonplated defects implanted with bBMP/NCP without ACG, all developed atrophic bone ends and fibrous tissue repair. Thus, to restore continuity of large segmental defects three times greater than the critical size for spontaneous regeneration, xenogeneic bBMP/NCP failed to induce bone regeneration in dogs. To exclude cell-mediated immune reactions and soft-tissue ingrowth, one defect was bridged with a polytetrafluoroethylene semipermeable tube (pore size 0.45 micron) containing implants of bBMP/NCP. In response to bBMP/NCP, cells from the host bone ends produced ossicles of induced woven bone formation. The observation that bBMP/NCP induced bone formation across the defect inside of semipermeable cylindrical chambers suggests that the experiments on bone defects larger than the critical size for spontaneous repair should be repeated with: (1) allogeneic dog BMP/NCP; (2) semipermeable cylinders to protect against muscle interposition; (3) compartment angiograms to evaluate blood supply; (4) treatment of the recipient with immunosuppressants and immunostaining to observe the concentration gradient of BMP; and (5) histologic observations on the first three days after implantation to evaluate cell-mediated immune barriers to the response of BMP.

Twelve patients with intractable nonunions of the femoral diaphyseal or metaphyseal-diaphyseal shaft were successfully treated by a combination of internal fixation and implants of human bone morphogenetic protein (h-BMP). There was an average of 4.3 surgical procedures per patient attempting union prior to h-BMP implantation. Union was obtained in 11 of 12 patients and in one patient with a repeat stabilization and implantation of h-BMP. Four patients received autogeneic cancellous bone graft and four patients received allogeneic bone grafts. The BMP implant was prepared in the form of an aggregate of h-BMP and bone matrix water-insoluble noncollagenous proteins (h-BMP/iNCP). Fifty to 100 mg of h-BMP/iNCP was either implanted in the fracture gap in ultra thin gelatin capsules, or incorporated in a strip of polylactic/polyglycolic acid copolymer (PLA/PGA) and placed as an onlay across the fracture gap. The average time to union was 4.7 months. Further clinical investigations are planned as a series of matched cases with and without BMP augmentation in order to distinguish h-BMP effects from new or improved methods of fracture fixation combined with autogeneic cancellous bone grafts.

Five patients with identical severely comminuted four-part intraarticular T-type fractures of the distal femur were treated with a combination of direct reduction of the condylar anatomy and indirect reduction of the metaphyseal fragments using a 95 degree blade plate and femoral distractor. In all patients there was a coronal-axial fracture of the medial condyle anterior to the origin of the posterior cruciate ligament (PCL) associated with disruption of the patellofemoral articulation (four-part fracture). There were no associated intraarticular or extraarticular knee ligament injuries with this specific fracture pattern. Following fracture stabilization all knees were stable. Anatomic reduction of the articular surface and restoration of alignment were obtained in every case. Functional results were rated as good to excellent in all patients.

Human bone morphogenetic protein (hBMP) is a bone cell differentiation-inducing factor. Six patients with traumatic segmental three- to 17-cm tibial defects developed solid union by implantation of hBMP and autogeneic cancellous grafts and stabilization. There were no allergic, infectious, or surgical complications. If hBMP augmentation in biodegradable delivery systems can be established by a prospective, randomized, double-blind investigation, the incidence of successful bone graft operations for treatment of large segmental defects would be measurably improved.

Vascular injury is one of the drastic complications that can arise from internal fixation of acetabular fractures. A 29-year-old, obese man sustained multiple trauma, including a displaced transverse acetabular fracture. Extreme obesity made adequate exposure to the posterior acetabular area difficult, causing placement of a large lag screw in malposition, such that it penetrated the superior pubic ramus at a point adjacent to the superficial femoral artery. Angiography, immediately after operation, revealed extrinsic compression of this vessel. The lag screw was successfully repositioned, with immediate return of vessel patency and no sequelae. The surgical approach and anatomic landmarks for placement of posterior to anterior lag screws are reviewed in an effort to prevent this complication.

Multiplane correctional osteotomy of the tibia was performed on seven patients with diaphyseal malunion involving deformity in more than one plane. All patients had preoperative complaints related to either disturbances of gait, associated joint or back pain, or a cosmetically unacceptable extremity. Correction of length, varus/valgus, anterior/posterior bowing, and internal/external torsion were possible. Stabilization by standard AO principles of lag screw compression and neutralization plating provided rigid fixation and early functional rehabilitation. All patients healed without complication and all returned to unrestricted activity. Preoperative planing, meticulous surgical technique, appropriate wedge resection, and correct application of internal fixation are required to obtain excellent surgical results.