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RCT
ACE Report #5839

Achilles tendon rupture: Surgery with accelerated rehab similar to non-surgical treatment


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

Stable Surgical Repair With Accelerated Rehabilitation Versus Nonsurgical Treatment for Acute Achilles Tendon Ruptures

Am J Sports Med. 2013 Dec;41(12):2867-76. doi: 10.1177/0363546513503282. Epub 2013 Sep 6.

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Synopsis

101 patients with an acute Achilles tendon rupture were randomized to one of two groups: a surgical group, wherein surgical repair was performed and early weight-bearing was encouraged, or a non-surgical group, wherein patients were treated conservatively and early weight-bearing was also encouraged. The purpose of this study was to evaluate these two treatment methods with respect to functional outcomes. Results indicated that patients in the surgical group were not significantly different than the non-surgical group with respect to function, physical activity levels post-injury, quality of life, and the incidence of re-ruptures.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
The Swedish National Center for Research in Sports
Conflicts:
Other

Risk of Bias

6/10

Reporting Criteria

17/20

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.

4/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

3/4

Therapy Description

4/4

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?

Currently, evidence regarding the optimal form of treatment for acute Achilles tendon ruptures is conflicting. In particular, topics such as surgical versus conservative treatment, early versus delayed loading, and mobilization of the tendon following surgery contribute to this ongoing debate. Adding even more complexity to the issue, outcomes that are traditionally reported include the incidence of re-ruptures; however, recent evidence suggests more emphasis should be placed on functional recovery, rather than the occurrence of these complications. Therefore, this study was needed to compare whether surgical repair with early tendon loading and range of motion was more beneficial in terms of functional and patient-reported outcomes than traditional conservative treatment for acute Achilles tendon rupture.

What was the principal research question?

Over a period of 1 year, did surgical repair with early tendon loading and range of motion yield better functional and patient-reported outcomes in patients with acute Achilles tendon ruptures when compared to traditional non-surgical treatment methods?

Study Characteristics -
Population:
101 patients (18-65 years) with an acute Achilles tendon rupture, diagnosed with a medical evaluation and a clinical evaluation (consisting of a palpable gap and a positive Thompson test result).
Intervention:
Surgical group: Patients in this group (n=49; 43 patients at final follow-up) underwent a standardized surgical procedure, performed in the prone position without the use of a tourniquet. End-to-end tendon repair was performed using two semi-absorbable sutures (No. 2 Orthocord, DePuy Mitek, Norwood, Massachusetts), placed using a modified Kessler technique, and a running circumferential suture as reinforcement (Absorbable sutures - No. 0 Polysorb, Tyco, Norwalk, Connecticut), placed using a cross-stitch technique. Without the use of a cast, the patients' ankles were immobilized immediately post-operatively using a pneumatic walker brace (Aircast XP Diabetic Walker, DJO, Vista, California), and full weight-bearing was encouraged from the first postoperative day. Range of motion and strength training began 2 weeks postoperatively. Patients in this group were mobilized in the brace for 6 weeks. (Mean age = 39.8 +/- 8.9 years; 80% male)
Comparison:
Non-surgical group: Patients in this group (n=51; 45 patients at final follow-up) were treated conservatively. Following randomization, these patients were placed in the same brace as the one used by the patients in the surgical group. Similar to the surgical group, full weight-bearing was encouraged from the beginning. Patients in this group were immobilized in the brace for 8 weeks. (Mean age = 39.5 +/- 9.7 years; 92% male)
Outcomes:
The primary outcome of this study was the Achilles tendon Total Rupture Score (ATRS). Secondary outcomes included the incidence of re-ruptures or other complications, as well as functional tests, patient-reported outcomes and physical activity levels (assessed using the Physical Activity Scale (PAS) questionnaire) measured at 3, 6, and 12 months. Patient-reported outcomes included the ATRS, 3 subscales (activities of daily living, function in sport and recreation, and ankle-related quality of life) of the Foot and Ankle Outcome Score (FAOS), and general health-related quality of life (assessed using the EuroQol Group's questionnaire (EQ-5D). Functional outcomes included two different jump tests (drop counter-movement jump and hopping), two different strength tests (concentric heel rise and eccentric-concentric heel rise on 1 leg), and one muscular endurance test (single-leg standing heel-rise test). These functional tests were performed using the MuscleLab measurement system (Ergotest Technology, Oslo, Norway) and were compared using the Limb Symmetry Index (LSI) (i.e. the ratio between the involved limb score and the uninvolved limb score).
Methods:
RCT: Single Centre
Time:
Clinical evaluations identifying complications took place at 2, 6, and 26 weeks in the surgical group and at 8 and 26 weeks in the non-surgical group. Patient-reported outcomes and functional evaluations took place three times throughout the study, at a mean of 12 +/- 0.7 weeks, 28 +/- 2.1 weeks and 56 +/- 4.3 weeks. The EQ-5D and PAS questionnaires were also completed at baseline.

What were the important findings?

  • Median ATRS scores significantly improved over time in both groups at the 3, 6 and 12 month follow-up time periods (p<0.001), however there was no significant difference in ATRS scores between the surgical and non-surgical groups at any time point (p>0.05).
  • Physical activity levels at 12 months post-operation, measured using the PAS questionnaire, were not significantly different from baseline in both the surgical group (p=0.78) and the non-surgical group (p=0.23).
  • The activities of daily living (ADL) and sport and recreation subscores of the FAOS significantly improved over time between all time frames (p<0.05), except for the ADL subscore between 6 and 12 months in the surgical group (p=0.10). There were no significant between-group differences in median FAOS ADL and sport and recreation subscores at 3 months (p=0.42 and p=0.24, respectively).
  • The quality of life (QOL) subscore of the FAOS significantly improved over time in both groups between all time frames (p<0.001). There were no significant between-group differences in median FAOS QOL subscores at 3 months (p=0.10).
  • Compared to baseline, quality of life measured by the EQ-5D was significantly decreased at 12 months in both the surgical and non-surgical groups (both p=0.03), however there was no significant difference between groups at this time point (p=0.30).
  • Except for concentric and eccentric power at 6 months, limb symmetry index (LSI) values were higher in the surgical group compared to the non-surgical group at all time points. However all of these differences, except for hopping and the drop counter-movement jump test at 12 months (p<0.05), were not considered statistically significant (p>0.05).
  • 0 patients in the surgical group and 5 patients in the non-surgical group (10%) suffered a re-rupture (between 5 and 12 weeks post-injury) (p=0.06), although 1 patient in the surgical group suffered a partial re-rupture. Following subsequent surgery on those with re-ruptures, there was no significant difference in all functional test scores between those who suffered from a re-rupture and those who did not at 6 and 12 months (p>0.05), except for the heel-rise height at 6 months (p=0.011).
  • 1 patient (2%) in the surgical group and 2 patients (4%) in the non-surgical group suffered a deep vein thrombosis. A superficial wound infection occurred in 12% of the patients in the surgical group (6 patients) and a persistent partial sural nerve disturbance occurred in 1 patient from the surgical group.

What should I remember most?

Surgical repair of an acute Achilles tendon rupture with early full weight-bearing, range of motion and strength training was not found to be statistically superior to non-surgical treatment with immediate weight-bearing, with respect to function, physical activity levels post-injury, quality of life, and the incidence of re-ruptures. It was also found that for those who suffered a re-rupture and underwent subsequent surgical repair, most functional scores measured at 6 and 12 months were not significantly different than those of patients who did not suffer a re-rupture.

How will this affect the care of my patients?

The results from this study suggest that surgical repair for acute Achilles tendon ruptures with immediate full weight-bearing and range of motion is well tolerated, but is not superior to non-surgical treatment with early weight-bearing. This lack of significance, however, may be attributable to type II error. Therefore, optimal treatment should be specific to the individual and their specific goals. Future research could assess this correlation more accurately by quantitatively measuring the amount of time patients actually spent bearing their weight post-injury, instead of simply encouraging the patients to immediately bear their full weight post-injury.

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Anonymous 2017-12-17 8:05 PM

Orthopaedic Surgeon - United States

definitely better to repair in terms of faster recovery and ultimate explosive strength