Foot & ankle. AJSM. 2016/6. A Prospective Randomized Trial Comparing Surgical and Nonsurgical Treatments of Acute Achilles Tendon Ruptures

 

Background: The optimal treatment of acute Achilles tendon ruptures for active patients is under debate.

 

Purpose: To compare clinical outcomes and calf muscle strength recovery after the nonsurgical treatment and open surgical repair of acute Achilles tendon ruptures with identical accelerated rehabilitation programs.

Study Design: Randomized controlled trial; Level of evidence, 1.

Methods: From 2009 to 2013, a total of 60 patients with an acute Achilles tendon rupture were randomized to surgery or nonsurgical treatment. Nonsurgical treatment included first a week of cast immobilization, followed by a functional orthosis for 6 weeks, allowing full weightbearing after week 1 and active plantar flexion after week 5. Surgery was simple end-to-end open repair, and postoperative treatment was identical to nonsurgical treatment. Outcome measures included the Leppilahti Achilles tendon performance score, isokinetic calf muscle strength, and RAND 36-Item Health Survey at 18-month follow-up.

Results: At 18-month follow-up, the mean Leppilahti score was 79.5 and 75.7 for the surgically and nonsurgically treated groups, respectively (mean difference, 3.8; 95% CI, –1.9 to 9.5; P = .19). Angle-specific peak torque results of affected legs showed that surgery resulted in faster and better recovery of calf muscle strength over the entire range of motion of the ankle joint: at 6 months, the difference varied from 16% to 24% (P = .016), favoring the surgically treated group, whereas at 18 months, surgically treated patients had 10% to 18% greater strength results (P = .037). At 18 months, a 14% difference in the peak torque of the affected leg favored the surgical group versus the nonsurgical group (mean peak torque, 110.3 vs 96.5 N·m, respectively; mean difference, 13.6 N·m; 95% CI, 2.0-25.1 N·m; P = .022). The RAND 36-Item Health Survey indicated better results in the domains of physical functioning (P = .006) and bodily pain (P = .037) for surgically treated patients.

Conclusion: Surgical and nonsurgical treatments of acute Achilles tendon ruptures have similar results in terms of the Achilles tendon performance score, but surgery restores calf muscle strength earlier over the entire range of motion of the ankle joint, with a 10% to 18% strength difference favoring surgery at 18 months. Surgery may also result in better health-related quality of life in the domains of physical functioning and bodily pain compared with nonsurgical treatment.

Sample Size Calculations The sample size was calculated using the Leppilahti score. The minimal clinically important difference was 10 points, the SD was 10, alpha was .05, and beta was .10, resulting in 17 patients in each group. To compensate for an estimated dropout rate of 30%, a total of 60 patients were to be enrolled in the study.

 

Randomization A biostatistician generated a random allocation sequence using computer software. A randomly varying block size (4, 6, or 8) was used, with each block having an equal number of surgically and nonsurgically treated patients. To control the possible confounding effect of age, randomization was performed separately in 2 age groups (≤35 and ≥35 years) with a ratio of 1:3 (n = 20) and 2:3 (n = 40), respectively. The effect of age on the Leppilahti score, peak torque, and rerupture rate was the only preplanned subgroup analysis. Two first authors (I.L., J.H.) examined all eligible patients and assigned them to interventions using mixed sealed envelopes within 2 days after the injury. Nonsurgical treatment was carried out immediately and surgical treatment within 24 hours after randomization.

 

Statistical Analysis Data were analyzed using the intention-to-treat principle.   Simple between-group comparisons - Student t test for continuous variables - Chi-square or Fisher exact test for categorical variables   Repeated measures  - Linear mixed model (LMM) with patients set as random effects. Between measurement correlations were accounted for by testing different covariance patterns and the best chosen using the Akaike information criterion.

 

 

1. radomization 이 잘 되어 있고, measure와 statistical analysis 가 세련되어있다.

2. Non-surgical 이어도 운동 프로그램이 좀 빡시다. (accelerated, expdited 여기 표현으로;) 그래서인지 rerupture 가 잦았다. (non-surgical 4/28, 14%) 하지만 vacoped orthosis 를 차지 않았거나, 무리를 하거나 어쨋든 compliance 가 안 좋은 상태에서 끊어졌다고 기술. 어찌되었든, 환자가 덜 불편하려면 수술을 권고하고, refuse 했을 때 rerupture waring 을 빡세게 해야할듯.

3. 차이는 있었지만, performance score는 비슷했다.

4. isokinetic calf muscle strength에서 빠르고 조금이나마 좋은 회복을 보였기 때문에, 젊고, 활동 적인 환자에서는 수술이 좋을거 같다는 결론.

5. non-surgical 에서는 빠른 재활운동으로 인한 tendon elongation 에 대한 불안함을 계속 내비침.

6. 7주 이후, 재활 운동 프로그램에 대해서 그림까지 곁들여서 잘 설명함.