Loading...
Visit our Evidence-Based Covid-19 Website and Stay Up to Date with the latest Research.
RCT
ACE Report #67

Non-operative management of Achilles tendon rupture equivalent to the surgical repair


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:1

Operative versus nonoperative treatment of acute Achilles tendon ruptures: a multicenter randomized trial using accelerated functional rehabilitation

J Bone Joint Surg Am. 2010 Dec 1;92(17):2767-75. Epub 2010 Oct 29.

Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here

Synopsis

144 patients with primary complete Achilles tendon rupture were randomized to be treated with either a surgical repair and accelerated functional rehabilitation or with only the accelerated functional rehabilitation. Over the course of a two year follow up, it was observed that Achilles tendon rupture led to clinically similar results between the two treatment groups.

Publication Funding Details +
Funding:
Industry funded
Sponsor:
Physicians Services, Inc. (PSI) and Aircast, Inc.
Conflicts:
None disclosed

Risk of Bias

6/10

Reporting Criteria

19/21

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Randomization

3/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

5/5

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

Achilles tendon rupture is a common sporting injury in adults with an increasing incidence due to continued sporting activity with growing age. So far evidence had favored surgical repair to be better in preventing re-rupture rates. However, the treatment of choice still remains controversial. Early weight-bearing with protected range of motion demonstrates better range of motion, strength, and return to activity, while minimizing re-ruptures or possibility of healing in a lengthened position. This study aimed to compare outcome of patients with acute Achilles tendon ruptures, who had been treated with operative repair and accelerated functional rehabilitation, with outcomes of similar patients who had been treated with accelerated functional rehabilitation alone.

What was the principal research question?

Are there any long-term differences in the results between patients receiving operative repair and accelerated functional rehabilitation versus those patients receiving accelerated functional rehabilitation alone, in the two-year post-operative period?

Study Characteristics -
Population:
144 patients, age range 18 to 70, with complete primary Achilles tendon rupture presenting within 14 days after injury, without ipsilateral or open injury
Intervention:
Operative treatment of the tendon (vertical posteromedial incision with nonabsorbable sutures, placed across the tear in a Krackow-type stitch pattern, and with foot placed in plantar flexion to appose tear ends) and accelerated functional rehabilitation (removable below-the-knee orthosis with 2-cm heel lift to provide 20 degrees of plantar flexion) (n=72)
Comparison:
Accelerated functional rehabilitation alone, as described above (n=72)
Outcomes:
Primary outcome measure was the rate of re-rupture. Secondary outcome measures were isokinetic strength, the Leppilahti score, ankle range of motion, and calf circumference
Methods:
Prospective, 2 center RCT
Time:
2 year follow up

What were the important findings?

  • At the 2-year follow-up, re-rupture occurred in two patients in the operative group at one and three months after injury and in three patients in the nonoperative group at one, two, and three months after injury.
  • There was significant difference in the plantar flexion strength ratio (affected to unaffected limb) at 240 degrees at two years (mean difference, 14.15%; 95% CI, 1.12% to 27.19%; p = 0.03) in favor of the operative group.
  • The mean range of dorsiflexion was 20.3 degrees +/- 12 degrees in the operative group and 17.9 degrees +/- 6.0 degrees in the nonoperative group. The mean range of plantar flexion was 44.5 degrees +/- 8.4 degrees in the operative group and 46.8 degrees +/- 8.5 degrees in the nonoperative group.
  • The side-to-side difference in plantar flexion range of motion was greater in the nonoperative group than in the operative group (mean difference between groups, 2.21 degrees; 95% CI, 3.9 degrees to 0.5 degrees; p = 0.01)
  • The mean side-to-side difference in calf circumference was 1.7 +/- 2.0 cm in the operative group and 1.5 +/- 5.6 cm in the nonoperative group. This difference was not significant (mean difference between groups, 0.2 cm; 95% CI, 1.8 to 1.3 cm; p = 0.75).
  • The mean Leppilahti score was 82.6 +/- 11.1 points in the operative group and 82.2 +/- 12.3 points in the nonoperative group. These values were not significant (mean difference: 0.4 point; 95% CI, 5.4 to 5.0 points; p = 0.89).
  • Study pitfalls, however, included no specification of intent to treat analysis, a largely male population, and an under-powered sample size.

What should I remember most?

The results of this study supported the use of accelerated functional rehabilitation and nonoperative treatment for acute Achilles tendon ruptures. All measured outcomes were clinically similar to those experienced for operative treatment. However, this study was under-powered.

How will this affect the care of my patients?

In patients with Achilles tendon rupture, accelerated functional rehabilitation appears to be effective when used after surgical and nonsurgical treatments. Further methodologically sound studies with sufficient power are necessary to confirm these findings.

CME Image

Continuing Medical Education Credits

You could be earning 0.5 CME credits for each report you read.

LEARN MORE

Please Login or Join to leave comments.