Operative vs Nonoperative Management of Unstable Medial Malleolus Fractures: A Randomized Clinical Trial.

Importance: Unstable ankle fractures are routinely managed operatively. However, because of soft tissue and implant-related complications, recent literature has reported on the nonoperative management of well-reduced medial malleolus fractures after fibular stabilization, but with limited evidence supporting the routine application. Objective: To assess the superiority of internal fixation of well-reduced (displacement ≤2 mm) medial malleolus fractures compared with nonfixation after fibular stabilization. Design, Setting, and Participants: This superiority, pragmatic, parallel, prospective randomized clinical trial was conducted from October 1, 2017, to August 31, 2021. A total of 154 adult participants (≥16 years) with a closed, unstable bimalleolar or trimalleolar ankle fracture requiring surgery at an academic major trauma center in the UK were assessed. Exclusion criteria included injuries with no medial-sided fracture, open fractures, neurovascular injury, and the inability to comply with follow-up. Data analysis was performed in July 2022 and confirmed in September 2023. Interventions: Once the lateral (and where appropriate, posterior) malleolus had been fixed and satisfactory intraoperative reduction of the medial malleolus fracture was confirmed by the operating surgeon, participants were randomly allocated to fixation (n = 78) or nonfixation (n = 76) of the medial malleolus. Main Outcome and Measure: Olerud-Molander Ankle Score (OMAS) 1 year after randomization (range, 0-100 points, with 0 indicating worst possible outcome and 100 indicating best possible outcome). Results: Among 154 randomized participants (mean [SD] age, 56.5 [16.7] years; 119 [77%] female), 144 (94%) completed the trial. At 1 year, the median OMAS was 80.0 (IQR, 60.0-90.0) in the fixation group compared with 72.5 (IQR, 55.0-90.0) in the nonfixation group (P = .17). Complication rates were comparable. Significantly more patients in the nonfixation group developed a radiographic nonunion (20% vs 0%; P < .001), with 8 of 13 clinically asymptomatic; 1 patient required surgical reintervention for this. Fracture type and reduction quality appeared to influence fracture union and patient outcome. Conclusions and Relevance: In this randomized clinical trial comparing internal fixation of well-reduced medial malleolus fractures with nonfixation, after fibular stabilization, fixation was not superior according to the primary outcome. However, 1 in 5 patients developed a radiographic nonunion after nonfixation, and although the reintervention rate to manage this was low, the future implications are unknown. These results support selective nonfixation of anatomically reduced medial malleolar fractures after fibular stabilization. Trial Registration: ClinicalTrials.gov Identifier: NCT03362229.

Ultrasound assessment of humeral shaft nonunion risk: a feasibility and proof of concept study.

PURPOSE: To determine the feasibility and reliability of ultrasound in the assessment of humeral shaft fracture healing and estimate the accuracy of 6wk ultrasound in predicting nonunion. METHODS: Twelve adults with a non-operatively managed humeral shaft fracture were prospectively recruited and underwent ultrasound scanning at 6wks and 12wks post-injury. Seven blinded observers evaluated sonographic callus appearance to determine intra- and inter-observer reliability. Nonunion prediction accuracy was estimated by comparing images for patients that united (n = 10/12) with those that developed a nonunion (n = 2/12). RESULTS: The mean scan duration was 8 min (5-12) and all patients tolerated the procedure. At 6wks and 12wks, sonographic callus (SC) was present in 11 patients (10 united, one nonunion) and sonographic bridging callus (SBC) in seven (all united). Ultrasound had substantial intra- (weighted kappa: 6wk 0.75; 12wk 0.75) and inter-observer reliability (intraclass correlation coefficient: 6wk 0.60; 12wk 0.76). At 6wks, the absence of SC demonstrated sensitivity 50%, specificity 100%, positive predictive value (PPV) 100% and negative predictive value (NPV) 91% in nonunion prediction (overall accuracy 92%). The absence of SBC demonstrated sensitivity 100%, specificity 70%, PPV 40% and NPV 100% in nonunion prediction (overall accuracy 75%). Of three patients at risk of nonunion (Radiographic Union Score for HUmeral fractures < 8), one had SBC on 6wk ultrasound (that subsequently united) and the others had non-bridging/absent SC (both developed nonunion). CONCLUSIONS: Ultrasound assessment of humeral shaft fracture healing was feasible, reliable and may predict nonunion. Ultrasound could be useful in defining nonunion risk among patients with reduced radiographic callus formation.

Fifteen-year prospective longitudinal cohort study of outcomes following single radius total knee arthroplasty.

Aims: This prospective study reports longitudinal, within-patient, patient-reported outcome measures (PROMs) over a 15-year period following cemented single radius total knee arthroplasty (TKA). Secondary aims included reporting PROMs trajectory, 15-year implant survival, and patient attrition from follow-up. Methods: From 2006 to 2007, 462 consecutive cemented cruciate-retaining Triathlon TKAs were implanted in 426 patients (mean age 69 years (21 to 89); 290 (62.7%) female). PROMs (12-item Short Form Survey (SF-12), Oxford Knee Score (OKS), and satisfaction) were assessed preoperatively and at one, five, ten, and 15 years. Kaplan-Meier survival and univariate analysis were performed. Results: At 15 years, 28 patients were lost to follow-up (6.1%) and 221 patients (51.9%) had died, with the mean age of the remaining cohort reducing by four years. PROMs response rates among surviving patients were: one-year 63%; five-year 72%; ten-year 94%; and 15-year 59%. OKS and SF-12 scores changed significantly over 15 years (p < 0.001). The mean improvement in OKS was 18.8 (95% confidence (CI) 16.7 to 19.0) at one year. OKS peaked at five years (median 43 years) declining thereafter (p < 0.001), though at 15 years it remained 17.5 better than preoperatively. Age and sex did not alter this trajectory. A quarter of patients experienced a clinically significant decline (≥ 7) in OKS from five to ten years and from ten to 15 years. The SF-12 physical component score displayed a similar trajectory, peaking at one year (p < 0.001). Patient satisfaction was 88% at one, five, and ten years, and 94% at 15 years. In all, 15-year Kaplan-Meier survival was 97.6% (95% CI 96.0% to 99.2%) for any revision, and 98.9% (95% CI 97.9% to 99.9%) for aseptic revision. Conclusion: Improvements in PROMs were significant and maintained following single radius TKA, with OKS peaking at five years, and generic physical health peaking at one year. Patient satisfaction remained high at 15 years, at which point 2.4% had been revised.

QuickDASH and PRWE Are Not Optimal Patient-Reported Outcome Measures After Distal Radial Fracture Due to Ceiling Effect: Potential Implications for Future Research.

BACKGROUND: The aim of this study was to determine the floor and ceiling effects for both the QuickDASH (shortened version of the Disabilities of the Arm, Shoulder and Hand [DASH] questionnaire) and the PRWE (Patient-Rated Wrist Evaluation) following a distal radial fracture (DRF). Secondary aims were to determine the degree to which patients with a floor or ceiling effect felt that their wrist was "normal" according to the Normal Wrist Score (NWS) and if there were patient factors associated with achieving a floor or ceiling effect. METHODS: A retrospective cohort study of patients in whom a DRF was managed at the study center during a single year was undertaken. Outcome measures included the QuickDASH, PRWE, EuroQol-5 Dimensions-3 Levels (EQ-5D-3L), and NWS. RESULTS: There were 526 patients with a mean age of 65 years (range, 20 to 95 years), and 421 (80%) were female. Most patients were managed nonsurgically (73%, n = 385). The mean follow-up was 4.8 years (range, 4.3 to 5.5 years). A ceiling effect was observed for both the QuickDASH (22.3% of patients with the best possible score) and the PRWE (28.5%). When defined as a score that differed from the best available score by less than the minimum clinically important difference (MCID) for the scoring system, the ceiling effect increased to 62.8% for the QuickDASH and 60% for the PRWE. Patients who had a ceiling score on the QuickDASH and the PWRE had a median NWS of 96 and 98, respectively, and those who had a score within 1 MCID of the ceiling score reported a median NWS of 91 and 92, respectively. On logistic regression analysis, a dominant-hand injury and better health-related quality of life were the factors associated with both QuickDASH and PRWE ceiling scores (all p < 0.05). CONCLUSIONS: The QuickDASH and PRWE demonstrate ceiling effects when used to assess the outcome of DRF management. Some patients achieving ceiling scores did not consider their wrist to be "normal." Future research on patient-reported outcome assessment tools for DRFs should aim to limit the ceiling effect, especially for individuals or groups that are more likely to achieve a ceiling score. LEVEL OF EVIDENCE: Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.

The Radiographic Union Score for ulnar fractures (RUSU) predicts ulnar shaft nonunion.

AIMS: To develop a reliable and effective radiological score to assess the healing of isolated ulnar shaft fractures (IUSF), the Radiographic Union Score for Ulna fractures (RUSU). METHODS: Initially, 20 patients with radiographs six weeks following a non-operatively managed ulnar shaft fracture were selected and scored by three blinded observers. After intraclass correlation (ICC) analysis, a second group of 54 patients with radiographs six weeks after injury (18 who developed a nonunion and 36 who united) were scored by the same observers. RESULTS: In the initial study, interobserver and intraobserver ICC were 0.89 and 0.93, respectively. In the validation study, the interobserver ICC was 0.85. The median score for patients who united was significantly higher than those who developed a nonunion (11 vs. 7, p < 0.001). A ROC curve demonstrated that a RUSU ≤ 8 had a sensitivity of 88.9% and specificity of 86.1% in identifying patients at risk of nonunion. Patients with a RUSU ≤ 8 (n = 21) were more likely to develop a nonunion (n = 16/21) than those with a RUSU ≥ 9 (n = 2/33; OR 49.6, 95% CI 8.6-284.7). Based on a PPV of 76%, if all patients with a RUSU ≤ 8 underwent fixation at 6 weeks, the number of procedures needed to avoid one nonunion would be 1.3. CONCLUSION: The RUSU shows good interobserver and intraobserver reliability and is effective in identifying patients at risk of nonunion six weeks after fracture. This tool requires external validation but may enhance the management of patients with isolated ulnar shaft fractures.

Surgical Versus Nonsurgical Management of Humeral Shaft Fractures: A Systematic Review and Meta-Analysis of Randomized Trials.

INTRODUCTION: The aim was to compare surgical and nonsurgical management for adults with humeral shaft fractures in terms of patient-reported upper limb function, health-related quality of life, radiographic outcomes, and complications. METHODS: MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, PubMed, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, International Clinical Trials Registry, and OpenGrey (Repository for Grey Literature in Europe) were searched in September 2021. All published prospective randomized trials comparing surgical and nonsurgical management of humeral shaft fractures in adults were included. Of 715 studies identified, five were included in the systematic review and four in the meta-analysis. Data were extracted by two independent reviewers according to the Preferred Reporting Items for Systematic Review and Meta-Analysis statement. Methodological quality was assessed using the revised Cochrane risk-of-bias tool for randomized trials. Pooled data were analyzed using a random-effects model. RESULTS: The meta-analysis comprised 292 patients (mean age 41 [18 to 83] years, 67% male). Surgery was associated with superior Disabilities of the Arm, Shoulder and Hand (DASH) and Constant-Murley scores at 6 months (mean DASH difference 7.6, P = 0.01; mean Constant-Murley difference 8.0, P = 0.003), but there was no difference at 1 year (DASH, P = 0.30; Constant-Murley, P = 0.33). No differences in health-related quality of life or pain scores were found. Surgery was associated with a lower risk of nonunion (0.7% versus 15.7%; odds ratio [OR] 0.13, P = 0.004). The number needed to treat with surgery to avoid one nonunion was 7. Surgery was associated with a higher risk of transient radial nerve palsy (17.4% versus 0.7%; OR 8.23, P = 0.01) but not infection (OR 3.57, P = 0.13). Surgery was also associated with a lower risk of reintervention (1.4% versus 19.3%; OR 0.14, P = 0.04). CONCLUSIONS: Surgery may confer an early functional advantage to adults with humeral shaft fractures, but this is not sustained beyond 6 months. The lower risk of nonunion should be balanced against the higher risk of transient radial nerve palsy. LEVEL OF EVIDENCE: Level I.

Outcome Following Acute Suture Anchor Repair of the Ulnar Collateral Ligament of the Thumb.

Background: The aim of this study was to evaluate the outcomes following acute repair of the ulnar collateral ligament of the thumb metacarpophalangeal joint (thumb UCL) using a suture anchor technique. Methods: From 2011 to 2019, we retrospectively identified 40 adult patients from a single centre who had undergone an acute thumb UCL repair (≤6 weeks post-injury). The mean age of the study cohort was 37 years (range 16-70) and 68% (n = 27/40) were male. The short-term outcomes included postoperative complications and failure of repair. The long-term outcomes were QuickDASH, the EuroQol 5-Dimension (EQ-5D), Visual Analogue Scale (EQ-VAS), return to sport and work and satisfaction with outcome. Results: The outcomes survey was completed at a mean of 4.3 years (range 1.0-9.2) for 33 patients (83%). Postoperative complications included self-limiting sensory disturbance (7.5%, n = 3/40), superficial infection (requiring oral antibiotics; 5%, n = 2/40) and wound dehiscence (requiring surgical debridement and re-closure; 2.5%, n = 1/40). No failures of repair were reported. The mean QuickDASH was 3.7 (range 0-27.3), EQ-5D 0.821 (range -0.041 to 1) and EQ-VAS 84 (range 60-100). Of the 32 employed patients, all returned to work at a median of 0.5 weeks (range 0-416) and the mean QuickDASH Work Module was 4.1 (range 0-50). Of the 24 patients playing sport prior to injury, 96% (n = 23/24) returned at a median of 16 weeks (range 5-52) and the mean QuickDASH Sport Module was 4.6 (range 0-25). All the patients were satisfied with their outcome (mean satisfaction score 9.8/10 [8-10O]). Conclusions: Thumb UCL repair using a suture anchor technique is safe and effective up to 6 weeks post injury. Pain and stiffness may persist in the longer term, but most patients report excellent upper limb function and health-related quality of life. The majority return to work and sport and are highly satisfied with their outcome. Level of Evidence: Level IV (Therapeutic).

Open Reduction and Tunneled Suspensory Device Fixation of Displaced Lateral-End Clavicular Fractures: Medium-Term Outcomes and Complications After Treatment.

BACKGROUND: Fractures of the lateral aspect of the clavicle with complete displacement have a high nonunion rate and are associated with poor functional outcomes following nonoperative treatment. Various techniques are available to treat these fractures, but preliminary studies of open reduction and tunneled suspensory device (ORTSD) fixation have shown good early functional outcomes with a low rate of complications; our goal was to assess the functional outcomes and complications in the medium term in a larger series of patients treated using this technique. METHODS: Sixty-seven patients with displaced lateral-end clavicular fractures were treated with ORTSD fixation. Outcome was assessed with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and the Oxford shoulder score at 6 weeks and 3, 6, and 12 months postoperatively. Fifty-five of 64 surviving patients were subsequently contacted at a mean of 69 months (range, 27 to 120 months) postoperatively to complete DASH and Oxford shoulder scores, to evaluate their overall level of satisfaction, and to document any further complications. RESULTS: At 1 year postoperatively, the mean Oxford shoulder score was 46.4 points and the mean DASH score was 2.4 points in 59 of the 67 patients assessed at this time interval. At the later follow-up (mean, 69 months), the mean Oxford shoulder score was 46.5 points and the mean DASH score was 2.2 points in the 55 surviving patients who were able to be contacted. There were no significant differences between the 1-year functional scores and those at the latest follow-up. Two patients developed a symptomatic nonunion requiring reoperation, and 2 patients developed an asymptomatic fibrous union not requiring a surgical procedure. The 5-year survival when considering only obligatory revision for implant-related complications was 97.0%. CONCLUSIONS: ORTSD fixation for isolated displaced lateral-end clavicular fractures in medically fit patients is associated with good functional outcomes and a low rate of complications in the medium term. Routine implant removal was not necessary. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Selective fixation of the medial malleolus in unstable ankle fractures.

BACKGROUND: Whilst the lateral malleolus appears to be crucial in controlling anatomical reduction of the talus, the role of the medial malleolus is less clear. Medial sided complications including infection, damage to local structures and symptomatic hardware are not without morbidity. This study compares the outcomes of patients with bimalleolar or trimalleolar ankle fractures who underwent fibular nail stabilisation with or without medial malleolar fixation. METHODS: From a prospective single-centre trauma database, we identified 342 patients over a nine-year period who underwent fibular nail insertion to stabilise a bimalleolar or trimalleolar ankle fracture. Isolated lateral malleolar fractures were excluded. Demographic data, clinical outcomes, radiographic evaluation, return to work and sport, and patient reported outcomes, including Olerud-Molander Ankle Score (OMAS), EuroQol-5D (EQ-5D) and Manchester-Oxford Foot Questionnaire (MOXFQ) were collected. RESULTS: This study included 247 patients with a mean age of 66.7 years (range, 25-96 years), of whom 200 were female (81%). Medial malleolar fixation was not performed in 54 cases (22%). There was no significant difference between groups with respect to failure of fixation (p = 0.634) or loss of talar reduction (p = 0.157). No patient required surgery for a symptomatic medial malleolar non-union. Medial sided complications occurred in 32 (16%) of the fixation group, of whom 20 (10%) required further surgery. At a mean mid-term follow-up of 4.8 years (range, 8 months - 9 years) there was no significant difference between the non-fixation and fixation groups with respect to the median OMAS (85 vs 80; p = 0.885) or median EQ-5D (0.80 vs 0.81; p = 0.846). Patient satisfaction was not significantly different between the two groups (85/100 vs 87/100; p = 0.410). CONCLUSION: Non-operative management of the medial malleolar component of an unstable ankle fracture treated with a fibular nail may reduce the rate of post-operative complications without compromising the patient reported outcome.

Excellent 10-year patient-reported outcomes and survival in a single-radius, cruciate-retaining total knee arthroplasty.

PURPOSE: Over 2 million Triathlon single-radius total knee arthroplasties (TKAs) have been implanted worldwide. This study reports the 10-year survival and patient-reported outcome of the Triathlon TKA in a single independent centre. METHODS: From 2006 to 2007, 462 consecutive cruciate-retaining Triathlon TKAs were implanted in 426 patients (median age 69 (21-89), 289 (62.5%) female). Patellae were not routinely resurfaced. Patient-reported outcome measures (SF-12, Oxford Knee Scores (OKS), satisfaction) were assessed preoperatively and at 1, 5 and 10 years when radiographs were reviewed. Forgotten Joint Scores (FJS) were collected at 10 years. Kaplan-Meier survival analysis was performed. RESULTS: At 10-11.6 years, 123 patients (128 TKAs) had died and 8 TKAs were lost to follow-up. There were four aseptic failures (two cases of tibial loosening, two cases of instability) and four septic failures requiring revision. Symptomatic aseptic radiographic loosening was present in three further cases at 11 years. Four (1%) patellae were secondarily resurfaced. OKS score improved by 17.7 ± 9.7 points at 1 year (p < 0.001), and was maintained at 34.7 ± 9.6 at 10 years with FJS 48.5 ± 31.4. Patient satisfaction was 88% at each timepoint. Ten-year survival was 97.9% (95% confidence interval 96.5-99.3) for revision for any reason, 98.9% (97.7-100) for mechanical failure, and 98.6% (97.4-99.8) for aseptic loosening (symptomatic radiographic or revised). CONCLUSION: The Triathlon TKA continues to show excellent longer-term results with high implant survivorship, low rates of aseptic failure, consistently maintained PROMs and excellent patient satisfaction rates of 88% at 10 years. LEVEL OF EVIDENCE: II, Prospective cohort study.

Optimizing Long-Term Outcomes and Avoiding Failure With the Fibula Intramedullary Nail.

OBJECTIVES: To identify risk factors for fixation failure, report patient outcomes, and advise on modifications to the surgical technique for fibula nail stabilization of unstable ankle fractures. DESIGN: Retrospective review. SETTING: Academic orthopaedic trauma unit. PATIENTS: All 342 patients were identified retrospectively from a prospectively collected single-center trauma database over a 9-year period. INTERVENTION: Unstable ankle fractures managed surgically with a fibula nail. MAIN OUTCOME MEASUREMENTS: The primary short-term outcome was failure, defined as any case that required revision surgery because of an inadequate mechanical construct. The mid-term outcomes included the Olerud-Molander Ankle Score and the Manchester-Oxford Foot Questionnaire. RESULTS: Twenty failures occurred (6%), of which 7 (2%) were due to device failure and 13 (4%) due to surgeon error. Of the surgeon errors, 8 consisted of inappropriate weight-bearing after syndesmotic diastasis, and 5 were due to inadequate fracture reduction or poor nail placement. Proximal locking screw (PLS) pull-out was the cause of all device failures. Positioning the PLS >20 mm above the plafond significantly increased failure risk (P = 0.003). At a mean follow-up of 5.1 years (range, 8 months-8 years) the median Olerud-Molander Ankle Score and Manchester-Oxford Foot Questionnaire were 80 (interquartile range, 45) and 10.94 (interquartile range, 44.00), respectively. Patient outcome was not negatively affected by the requirement for revision surgery. CONCLUSIONS: The fibula nail offers secure fixation and good patient-reported outcomes for unstable ankle fractures. Appropriate postoperative management and surgical technique, including careful placement of the PLS, is essential to minimize construct failure risk. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.