Robert Handley

Dynamic Ultrasound as a Selection Tool for Reducing Achilles Tendon Reruptures

Background The optimal method of treatment for acute tendo-Achilles ruptures continues to be debated. Hypothesis The reported lower rerupture rate for operatively treated patients is an effect of tendon end apposition during the healing process, and patients in whom apposition can be demonstrated using ultrasound will have a similar rate of rerupture if treated nonoperatively. Study Design Cohort study; Level of evidence, 2. Method The authors reviewed all patients with an Achilles tendon rupture who were treated to a standard protocol during a 5-year period (2000-2005). Patients with a gap of 5 mm or more in equinus on ultrasound underwent surgery; those with a gap of less than 5 mm received nonoperative treatment. All patients were followed up to a minimum of 12 months. Results: After exclusions, 125 patients were included 67 treated operatively and 58 nonoperatively. There were 2 reruptures in the nonoperative group and 1 with surgery. There was no significant difference between the groups for any complication. Conclusion Reduction of rerupture and surgery risks may be possible using dynamic ultrasound case selection. Further studies are needed to show whether functional results are the same with surgical and nonsurgical treatment when dynamic ultrasound criteria are used for case selection.

Close contact casting vs surgery for initial treatment of unstable ankle fractures in older adults: A randomized clinical trial

Importance Ankle fractures cause substantial morbidity in older persons. Surgical fixation is the contemporary intervention but is associated with infection and other healing complications. Objective To determine whether initial fracture treatment with close contact casting, a molded below-knee cast with minimal padding, offers outcome equivalent to that with immediate surgery, with fewer complications and less health resource use. Design, Setting, and Participants This was a pragmatic, equivalence, randomized clinical trial with blinded outcome assessors. A pilot study commenced in May 2004, followed by multicenter recruitment from July 2010 to November 2013; follow-up was completed May 2014. Recruitment was from 24 UK major trauma centers and general hospitals. Participants were 620 adults older than 60 years with acute, overtly unstable ankle fracture. Exclusions were serious limb or concomitant disease or substantial cognitive impairment. Interventions Participants were randomly assigned to surgery (n = 309) or casting (n = 311). Casts were applied in the operating room under general or spinal anesthesia by a trained surgeon. Main Outcomes and Measures The primary 6-month, per-protocol outcome was the Olerud-Molander Ankle Score at 6 months (OMAS; range, 0-100; higher scores indicate better outcomes and fewer symptoms), equivalence prespecified as ±6 points. Secondary outcomes were quality of life, pain, ankle motion, mobility, complications, health resource use, and patient satisfaction. Results Among 620 adults (mean age, 71 years; 460 [74%] women) who were randomized, 593 (96%) completed the study. Nearly all participants (579/620; 93%) received allocated treatment; 52 of 275 (19%) who initially received casting later converted to surgery, which was allowable in the casting treatment pathway to manage early loss of fracture reduction. At 6 months, casting resulted in ankle function equivalent to that with surgery (OMAS score, 66.0 [95% CI, 63.6-68.5] for surgery vs 64.5 [95% CI, 61.8-67.2] for casting; mean difference, -0.6 [95% CI, -3.9 to 2.6]; P for equivalence = .001). Infection and wound breakdown were more common with surgery (29/298 [10%] vs 4/275 [1%]; odds ratio [OR], 7.3 [95% CI, 2.6-20.2]), as were additional operating room procedures (18/298 [6%] for surgery and 3/275 [1%] for casting; OR, 5.8 [95% CI, 1.8-18.7]). Radiologic malunion was more common in the casting group (38/249 [15%] vs 8/274 [3%] for surgery; OR, 6.0 [95% CI, 2.8-12.9]). Casting required less operating room time compared with surgery (mean difference [minutes/participant], -54 [95% CI, -58 to -50]). There were no significant differences in other secondary outcomes: quality of life, pain, ankle motion, mobility, and patient satisfaction. Conclusions and Relevance Among older adults with unstable ankle fracture, the use of close contact casting compared with surgery resulted in similar functional outcomes at 6 months. Close contact casting may be an appropriate treatment for such patients. Trial Registration isrctn.com Identifier: ISRCTN04180738.

Three-Year Follow-up of a Trial of Close Contact Casting vs Surgery for Initial Treatment of Unstable Ankle Fractures in Older Adults

A randomized clinical trial of close contact casting vs the usual practice of surgery for treating unstable ankle fractures in older adults found equivalent ankle function outcomes at 6 months.1 Higher rates of radiological ankle malunion in the casting vs surgical groups (15% vs 3%, respectively) and nonunion (medial malleolus: 7% vs 1%, respectively) suggested that equivalence between the 2 groups may be lost if symptoms or functional limitations from posttraumatic arthritis manifest later.2 A follow-up at least 3 years after randomization was conducted to determine if equivalence persisted over time. Methods: This study was a prespecified extended follow-up of a pragmatic, multicenter, equivalence randomized clinical trial.1 The National Research Ethics Service, Oxfordshire, gave approval; written informed consent was obtained. Participants were adults older than 60 years with acute unstable malleolar fracture(s) from 24 UK centers. Participants had received surgery (usual local practice internal fixation) or close contact casting, in which a minimally padded cast was applied after closed fracture reduction by an orthopedic surgeon in an operating room under anesthesia. Data were collected for at least 3 years after randomization using patient-reported postal questionnaires. The primary outcome measure for the original trial was the Olerud and Molander Ankle Score (OMAS; range, 0-100, higher scores = better ankle function) at 6 months,3 with a prespecified equivalence margin of ±6 points. Extended follow-up used the same primary outcome and equivalence margin and assessed quality of life and pain as secondary outcomes (Table 1). A post hoc analysis of additional operations after 6 months was also conducted. Per-protocol primary analysis was used, consistent with the main trial.1 Random-effects models estimated mean differences and 95% CIs between treatments adjusted for age, sex, fracture pattern, baseline score, and time to follow-up, including the center variable as a random effect. The random-effects model was also used post hoc to assess differences in OMAS for participants with vs without radiological malunion and nonunion at 6 months. Change from baseline score was analyzed for outcomes without normal distribution. The primary outcome at extended follow-up assessed equivalence with the null hypothesis that the 2 groups were not equivalent. For all other outcomes, tests were 2-sided with a P value of .05 or less for significance. Analyses were conducted with Stata (StataCorp), version 15.0. Results: From September 2013 through November 2016, 450 of the 620 randomized participants (73%) responded to follow-up at a median of 3 years (range, 2.9-9.5). Responders and nonresponders had similar characteristics (Table 1). Most responders lived in their own home (209 of 222 participants [94%] in the surgery group and 196 of 206 participants [95%] in the casting group). Surgery and casting participants had equivalent ankle function (mean OMAS: 79.4 in the surgery group vs 76.3 in the casting group; difference, −1.3 [95% CI, −5.6 to 3.0]) and no significant differences in quality of life or pain (Table 2). Twenty-two of 222 surgery participants (10%) and 17 of 206 casting participants (8%) had operations after 6 months, including surgical implant removals (15 in the surgery group [7%] vs 8 in the casting group [4%]), arthrodesis (1 in the surgery group [0.5%] vs 3 in the casting group [1.5%]), arthroplasty (1 in the surgery group [0.5%] and 1 in the casting group [0.5%]), and infection-related procedures (2 in the surgery group [1%] and 0 in the casting group). Five casting participants (2%) had internal fixations for nonunion after 6 months. There was 1 internal fixation revision, 1 arthroscopy, and 1 hindfoot osteotomy among surgery participants. In post hoc analysis, from randomization to extended follow-up, mean total operating room procedures per participant (per protocol) were 1.2 (SD, 0.5) in the surgery group and 1.3 (SD, 0.6) in the casting group, and mean total surgical procedures per participant were 1.2 (SD, 0.5) in the surgery group and 0.3 (SD, 0.6) in the casting group. Of 67 participants with radiological abnormalities at 6 months, 43 (64%) provided extended follow-up data. Those with malleolar malunion at 6 months had significantly lower OMAS scores (n = 30; mean, 58.7 [SD, 33.1]) than those without (n = 372; mean, 79.8 [SD, 23.5]; mean difference, −16.4 [95% CI, −25.0 to −7.8]; P < .001). Participants with medial malleolar nonunion at 6 months also had significantly lower OMAS scores (n = 13; mean, 55.4 [SD, 38.5]) than those without (n = 388; mean, 79.1 [SD, 23.9]; mean difference, −13.9 [95% CI, −26.6 to −1.2]; P = .03). Treatment was not a significant covariate in these analyses. Discussion: Equivalence in function between casting and immediate surgery strategies was maintained at 3 years. In post hoc analyses, participants with radiological malunion and medial malleolar nonunion at 6 months had lower OMAS scores at 3-year follow-up. These longer-term outcomes will support surgeon and patient decision making. The findings indicate that treatment of ankle fractures in older adults should focus on obtaining and maintaining a reduction until union, by the most conservative means possible. The study was limited by its reliance on self-reported events requiring participant recall and by loss to follow-up. However, there were sufficient data to estimate and conclude equivalence in the primary outcome.