Is Immobilization Necessary for Early Return to Work Following Distal Biceps Repair Using a Cortical Button Technique?: A Randomized Controlled Trial.

BACKGROUND: Improvements in surgical fixation to repair distal biceps tendon ruptures have not fully translated to earlier postoperative mobilization; it is unknown whether earlier mobilization affords earlier functional return to work. This parallel-arm randomized controlled trial compared the impact of early mobilization versus 6 weeks of postoperative immobilization following distal biceps tendon repair. METHODS: One hundred and one male participants with a distal biceps tendon rupture that was amenable to a primary repair with use of a cortical button were randomized to early mobilization (self-weaning from sling and performance of active range of motion as tolerated during first 6 weeks) (n = 49) or 6 weeks of immobilization (splinting for 6 weeks with no active range of motion) (n = 52). Follow-up assessments were performed by a blinded assessor at 2 and 6 weeks and at 3, 6, and 12 months. At 12 months, distal biceps tendon integrity was verified with ultrasound. The primary outcome was return to work. Secondary outcomes were pain, range of motion, strength, shortened Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) score, and tendon integrity. Intention-to-treat analysis was performed. A linear mixed model for repeated measures was used to compare pain, range of motion, strength, and QuickDASH between the groups over time; return to work was assessed with use of independent t tests. RESULTS: The groups were similar preoperatively (p ≥ 0.16). The average age (and standard deviation) was 44.7 ± 8.6 years. Eighty-three participants (82%) were followed to 12 months. There were no differences between the groups in terms of return to work (p ≥ 0.83). Participants in the early mobilization group had significantly more passive forearm supination (p = 0.04), with passive forearm pronation (p = 0.06) and active extension and supination (p = 0.09) trending toward significantly greater range of motion in the early mobilization group relative to the immobilization group. Participants in the early mobilization group had significantly better QuickDASH scores over time than those in the immobilization group (p = 0.02). There were no differences between the groups in terms of pain (p ≥ 0.45), active range of motion (p ≥ 0.09), or strength (p ≥ 0.70). Two participants (2.0%, 1 in each group) had full-thickness tears on ultrasound at 12 months (p = 0.61). Compliance was not significantly different between the groups (p = 0.16). CONCLUSIONS: Early motion after distal biceps tendon repair with cortical button fixation is well tolerated and does not appear to be associated with adverse outcomes. No clinically important group differences were seen. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Midterm Outcomes of a Synthetic Cartilage Implant for the First Metatarsophalangeal Joint in Advanced Hallux Rigidus.

BACKGROUND:: A prospective, randomized, noninferiority clinical trial of synthetic cartilage implant hemiarthroplasty for hallux rigidus demonstrated functional outcomes and safety equivalent to first metatarsophalangeal (MTP) joint arthrodesis at 24 months. We prospectively assessed safety and efficacy outcomes for synthetic cartilage implant hemiarthroplasty at a minimum of 5 years. METHODS:: Of 135 eligible patients from the original trial, 112 (83.0%) were enrolled (mean age, 58.2 ± 8.8 years; 87 females). Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL), and FAAM Sports subscales were completed preoperatively and 2 and 5 years postoperatively. Great toe active dorsiflexion, weightbearing radiographs, secondary procedures, and safety parameters were also evaluated. RESULTS:: At 24 months, 14/152 (9.2%) patients had undergone implant removal and conversion to arthrodesis. In years 2 to 5, 9/119 (7.6%) patients underwent implant removal and conversion to arthrodesis. At mean 5.8 ± 0.7 (range, 4.4-8.0) years' follow-up, pain VAS, FAAM ADL, and FAAM Sports scores improved by 57.9 ± 18.6 points, 33.0 ± 17.6 points, and 47.9 ± 27.1 points, respectively, from baseline. Clinically significant changes in VAS pain, FAAM ADL, and FAAM Sports were reported by 103/106 (97.2%), 95/105 (90.5%), and 97/104 (93.3%) patients, respectively. Patient-reported outcomes at 24 months were maintained at 5.8 years in patients who were not revised. Active MTP joint peak dorsiflexion was maintained. Ninety-nine of 106 (93.4%) patients would have the procedure again. CONCLUSION:: Clinical and safety outcomes for synthetic cartilage implant hemiarthroplasty observed at 2 years were maintained at 5.8 years. The implant remains a viable treatment option to decrease pain, improve function, and maintain motion for advanced hallux rigidus. LEVEL OF EVIDENCE:: Level IV, case series.

Treatment of first metatarsophalangeal joint arthritis using hemiarthroplasty with a synthetic cartilage implant or arthrodesis: A comparison of operative and recovery time.

BACKGROUND: First metatarsophalangeal joint (MTPJ1) hemiarthroplasty using a novel synthetic cartilage implant was as effective and safe as MTPJ1 arthrodesis in a randomized clinical trial. We retrospectively evaluated operative time and recovery period for implant hemiarthroplasty (n=152) and MTPJ1 arthrodesis (n=50). METHODS: Perioperative data were assessed for operative and anaesthesia times. Recovery and return to function were prospectively assessed with the Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) subscales and SF-36 Physical Functioning (PF) subscore. RESULTS: Mean operative time for hemiarthroplasty was 35±12.3min and 58±21.5min for arthrodesis (p<0.001). Anaesthesia duration was 28min shorter with hemiarthroplasty (p<0.001). At weeks 2 and 6 postoperative, hemiarthroplasty patients demonstrated clinically and statistically significantly higher FAAM Sport, FAAM ADL, and SF-36 PF subscores versus arthrodesis patients. CONCLUSION: MTPJ1 hemiarthroplasty with a synthetic cartilage implant took less operative time and resulted in faster recovery than arthrodesis. LEVEL OF EVIDENCE: III, Retrospective case control study.

Correlation of Hallux Rigidus Grade With Motion, VAS Pain, Intraoperative Cartilage Loss, and Treatment Success for First MTP Joint Arthrodesis and Synthetic Cartilage Implant.

BACKGROUND: Grading systems are used to assess severity of any condition and as an aid in guiding treatment. This study examined the relationship of baseline motion, pain, and observed intraoperative cartilage loss with hallux rigidus grade. METHODS: A prospective, randomized study examining outcomes of arthrodesis compared to synthetic cartilage implant was performed. Patients underwent preoperative clinical examination, radiographic assessment, hallux rigidus grade assignment, and intraoperative assessment of cartilage loss. Visual analog scale (VAS) score for pain was obtained preoperatively and at 24 months. Correlation was made between active peak dorsiflexion, VAS pain, cartilage loss, and hallux rigidus grade. Fisher's exact test was used to assess grade impact on clinical success ( P < .05). RESULTS: In 202 patients, 59 (29%), 110 (55%), and 33 (16%) were classified as Coughlin grades 2, 3, and 4, respectively. There was no correlation between grade and active peak dorsiflexion (-0.069, P = .327) or VAS pain (-0.078, P = .271). Rank correlations between grade and cartilage loss were significant, but correlations were small. When stratified by grade, composite success rates between the 2 treatments were nearly identical. CONCLUSIONS: Irrespective of the grade, positive outcomes were demonstrated for both fusion and synthetic cartilage implant. Clinical symptoms and signs should be used to guide treatment, rather than a grade consisting of radiographic, symptoms, and range of motion factors. LEVEL OF EVIDENCE: Level II, randomized clinical trial.

Association Between Patient Factors and Outcome of Synthetic Cartilage Implant Hemiarthroplasty vs First Metatarsophalangeal Joint Arthrodesis in Advanced Hallux Rigidus.

BACKGROUND: We evaluated data from a clinical trial of first metatarsophalangeal joint (MTPJ1) implant hemiarthroplasty and arthrodesis to determine the association between patient factors and clinical outcomes. METHODS: Patients ≥18 years with hallux rigidus grade 2, 3, or 4 were treated with synthetic cartilage implant MTPJ1 hemiarthroplasty or arthrodesis. Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) sports and activities of daily living (ADL) scores, and Short Form-36 Physical Function (SF-36 PF) subscore were obtained preoperatively, and at 2, 6, 12, 24, 52, and 104 weeks postoperatively. Final outcome data, great toe active dorsiflexion motion, secondary procedures, radiographs, and safety parameters were evaluated for 129 implant hemiarthroplasties and 47 arthrodeses. The composite primary endpoint criteria for clinical success included VAS pain reduction ≥30%, maintenance/improvement in function, no radiographic complications, and no secondary surgical intervention at 24 months. Predictor variables included hallux rigidus grade; gender; age; body mass index (BMI); symptom duration; prior MTPJ1 surgery; preoperative hallux valgus angle, range of motion (ROM), and pain. Two-sided Fisher exact test was used ( P < .05). RESULTS: Patient demographics and baseline outcome measures were similar. Success rates between implant MTPJ1 hemiarthroplasty and arthrodesis were similar ( P > .05) when stratified by hallux rigidus grade, gender, age, BMI, symptom duration, prior MTPJ1 surgery status, and preoperative VAS pain, hallux valgus, and ROM. CONCLUSION: Synthetic cartilage implant hemiarthroplasty was appropriate for patients with grade 2, 3, or 4 hallux rigidus. Its results in those with associated mild hallux valgus (≤20 degrees) or substantial preoperative stiffness were equivalent to MTPJ1 fusion, irrespective of gender, age, BMI, hallux rigidus grade, preoperative pain or symptom duration. LEVEL OF EVIDENCE: Level II, randomized clinical trial.

Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

BACKGROUND: Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. METHODS: In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (<15%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17 patients withdrew after randomization, and 22 were nonrandomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups. RESULTS: VAS pain scores decreased significantly in both the implant and arthrodesis groups from baseline at 12 and 24 months. Similarly, the FAAM sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6.2 degrees (27.3%) after implant placement and was maintained at 24 months. Subsequent secondary surgeries occurred in 17 (11.2%) implant patients (17 procedures) and 6 (12.0%) arthrodesis patients (7 procedures). Fourteen (9.2%) implants were removed and converted to arthrodesis, and 6 (12.0%) arthrodesis patients (7 procedures [14%]) had isolated screws or plate and screw removal. There were no cases of implant fragmentation, wear, or bone loss. When analyzing the ITT and mITT population for the primary composite outcome of VAS pain, function (FAAM sports), and safety, there was statistical equivalence between the implant and arthrodesis groups. CONCLUSION: A prospective, randomized (2:1), controlled, noninferiority clinical trial was performed to compare the safety and efficacy of a small synthetic cartilage bone implant to first MTP arthrodesis in patients with advanced-stage hallux rigidus. This study showed equivalent pain relief and functional outcomes. The synthetic implant was an excellent alternative to arthrodesis in patients who wished to maintain first MTP motion. The percentage of secondary surgical procedures was similar between groups. Less than 10% of the implant group required revision to arthrodesis at 2 years. LEVEL OF EVIDENCE: Level I, prospective randomized study.

Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a ß-TCP-Collagen Matrix.

BACKGROUND: Ankle and hindfoot arthrodesis is often supplemented with autograft to promote bony union. Autograft harvest can lead to increased perioperative morbidity. Purified recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) has stimulated bone formation in mandibular defects and hindfoot fusion. This randomized controlled trial evaluated the efficacy and safety of rhPDGF-BB combined with an injectable, osteoconductive beta-tricalcium phosphate (ß-TCP)-collagen matrix versus autograft in ankle and hindfoot fusions. METHODS: Seventy-five patients requiring ankle or hindfoot fusion were randomized 5:1 for rhPDGF-BB/ß-TCP-collagen (treatment, n = 63) or autograft (control, n = 12). Prospective analysis included 142 autograft control subjects from another clinical trial with identical study protocols. Standardized operative and postoperative protocols were used. Patients underwent standard internal fixation augmented with autograft or 0.3 mg/mL rhPDGF-BB/ß-TCP-collagen. Radiologic, clinical, and quality-of-life outcomes were assessed over 52 weeks. Primary outcome was joint fusion (50% or more osseous bridging on computed tomography) at 24 weeks. Secondary outcomes included radiographs, clinical healing status, visual analog scale pain score, American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Scale score, Foot Function Index score, and Short Form-12 score. Noninferiority P values were calculated. RESULTS: Complete fusion of all involved joints at 24 weeks as indicated by computed tomography was achieved in 53 of 63 (84%) rhPDGF-BB/ß-TCP-collagen-treated patients and 100 of 154 (65%) autograft-treated patients (P < .001). Mean time to fusion was 14.3 ± 8.9 weeks for rhPDGF-BB/ß-TCP-collagen patients versus 19.7 ± 11.5 weeks for autograft patients (P < .01). Clinical success at 52 weeks was achieved in 57 of 63 (91%) rhPDGF-BB/ß-TCP-collagen patients and 120 of 154 (78%) autograft patients (P < .001). Safety-related outcomes were equivalent. Autograft controls had 2 bone graft harvest infections. CONCLUSIONS: Application of rhPDGF-BB/ß-TCP-collagen was a safe, effective alternative to autograft for ankle and hindfoot fusions, eliminating the pain and morbidity associated with autograft harvesting. LEVEL OF EVIDENCE: Level I, prospective randomized study.

A prospective randomized controlled trial of a bioresorbable calcium phosphate paste (alpha-BSM) in treatment of displaced intra-articular calcaneal fractures.

BACKGROUND: Displaced intra-articular calcaneal fractures are devastating injuries and pose a therapeutic challenge. The purpose of this study was to determine whether open reduction internal fixation (ORIF) plus an injectable bioresorbable calcium phosphate paste (alpha-BSM [bone substitute material]) is superior to ORIF alone in the treatment of calcaneal bone voids encountered after operative treatment of displaced intra-articular calcaneal fractures. METHODS: We prospectively randomized 47 patients with 52 closed displaced intra-articular fractures necessitating operative fixation to receive ORIF alone (n = 28) or ORIF plus alpha-BSM (n = 24). The maintenance of Böhler's angle was evaluated at follow-up visits for more than 1 year. Secondary outcome measures included the SF-36 and lower extremity measure every 6 months, and the Oral Analog Scale (OAS) score at 2 years. RESULTS: There was no difference between the groups in the degree of collapse of Böhler's angle at 6 weeks and 3 months when compared with initial postoperative values. However, at 6 months, the mean collapse of the alpha-BSM and ORIF group was 5.6 degree (SD, 4.5 degree) and ORIF alone was 9.1 degree (SD, 5.8 degree), which was statistically significant (p = 0.03). Final radiographic evaluation after 1 year revealed a Böhler's angle loss of 6.2 degree (SD 5.9 degree) and 10.4 degree (SD 7.1 degree) in alpha-BSM and ORIF and ORIF alone groups, respectively, (p = 0.05). There was no difference between the two groups in regards to secondary outcome measures of general health, limb specific function, and pain past 2 years. CONCLUSION: These results support the use of an injectable, in situ hardening calcium phosphate paste to fill the bone void after a displaced intra-articular calcaneal fracture. There was no impact on general health, limb specific function, and pain past 2 years and no associated complications with alpha-BSM use, supporting it safety as an augment to ORIF.

External ring fixation versus screw fixation for ankle arthrodesis: a biomechanical comparison.

BACKGROUND: The use of external ring fixation for ankle arthrodesis offers an alternative to internal screw fixation when bone quality is suboptimal, when complex ankle pathology is present, and as a salvage procedure for complicated cases. Additionally, it permits earlier weightbearing and postoperative adjustment of bone alignment and joint compression. This study was designed to determine whether there are differences in initial ankle joint fixation integrity between these two techniques. MATERIALS AND METHODS: Ten fresh-frozen cadaveric lower extremities underwent ankle arthrodesis with a hybrid ring fixator, and the bending and torsional stiffness of each arthrodesed joint was quantified. Stiffness was calculated from angulation measured at the tibiotalar joint using electronic clinometers attached to those bones. The external fixators were then removed and ankle arthrodesis performed using 6.5-mm cannulated screws: three across the ankle joint, one fixing the fibula to the tibia, and one fixing the fibula to the talus. Stiffness testing was then repeated. RESULTS: No statistically significant difference in bending stiffness, torsional stiffness, or joint rotation under torsional load was demonstrable between the two techniques. CONCLUSION: The similarity in ankle fusion site stability achieved with external ring fixation and an optimized screw fixation technique under the described testing conditions indicates that, in cases in which suboptimal bone quality or complex ankle pathology preclude the use of internal fixation, an external fixator is a viable option. CLINICAL RELEVANCE: Establishing that the primary stability of external ring fixation is comparable to that of screw fixation provides a basis for its use in cases in which screw fixation may be problematic.

Computer-assisted surgery for subtalar arthrodesis. A study in cadavers.

BACKGROUND: Despite considerable recent interest in computer navigation for orthopaedic surgery, few investigations of computer-assisted surgery for foot and ankle operations have been reported. The purpose of the present study was to compare subtalar arthrodesis with and without computer navigation in a cadaver model. METHODS: Subtalar arthrodesis was performed on thirty-six matched-pair cadaver lower extremities with intact soft tissues, with an attempt being made to orient two screws in the optimal configuration based on unpublished data from a preceding biomechanical study. Each matched pair was randomly assigned either to a group of surgeons who were experienced in subtalar arthrodesis or to a group of inexperienced operators. Neither surgical group was experienced in computer-assisted surgery. We compared optimal first-pass guidewire placement, fluoroscopic time, total operative time, screw placement accuracy, and adverse screw placement events between conventional (fluoroscopically guided) and computer-assisted subtalar arthrodesis. RESULTS: The number of passes needed to achieve optimal guidewire placement decreased with the use of computer assistance for both experienced surgeons and inexperienced operators (p < 0.001), with ideal placement occurring on the first attempt in 95% of the procedures performed with use of computer assistance. While the experienced surgeons required less time and fewer guidewire passes during conventional subtalar arthrodesis than the inexperienced operators did (p < 0.001), both groups used less fluoroscopy with computer assistance (p < 0.001). There was no significant difference in operative time between the two techniques when performed by the inexperienced operators, yet the total procedure time doubled for the experienced surgeons when the procedure was performed with use of computer assistance (p < 0.001). There was no significant difference between experienced surgeons and inexperienced operators or between conventional and computer-assisted subtalar arthrodesis with respect to adverse screw placement events or the ability to accurately place both screws. CONCLUSIONS: Computer-assisted subtalar arthrodesis resulted in screw placement accuracy that was equivalent to that of conventional (fluoroscopically guided) subtalar arthrodesis while decreasing the number of suboptimal guidewire passes and fluoroscopic time. The computer-assisted surgery technique increased the operative time for surgeons who were more experienced in conventional subtalar arthrodesis, but there was no difference in operative time for the group of operators who were inexperienced in subtalar arthrodesis.