Levels of Evidence for Primary Research Question
Grades of Recommendation for Summaries or Reviews of Orthopaedic Surgical Studies
Catastrophic rupture of the Achilles tendon (Figure 1) occurs when applied forces exceed the tensile limits of the tendon, likely related to preexisting pathologic changes that may cause weakness. Recently, methods of evidence-based medicine (EBM) have been used in an attempt to clarify the treatment of Achilles tendon ruptures.
Figure 1. Ruptured Achilles tendon
One of the more publicized examples of EBM is the clinical practice guideline, Diagnosis and Treatment of Acute Achilles Tendon Rupture, published by the American Academy of Orthopaedic Surgery in 2010.1 The guideline is based on a series of systematic reviews of published studies in the available literature. In this EBM review, 16 aspects of the diagnosis and treatment of Achilles tendon ruptures were examined. The studies identified were then assigned a Level of Evidence.
The quality of treatment studies were assessed using a two-step process. First, a Level of Evidence was assigned to all results reported in a study based solely on that study’s design:
- All data presented in randomized controlled trials (RCT) were initially categorized as Level I evidence
- All results presented in non-randomized controlled trials and other prospective comparative studies were initially categorized as Level II
- All results presented in retrospective comparative and case-control studies were initially categorized as Level III
- All results presented in case-series reports were initially categorized as Level IV.
Then, the quality and quantity of the available evidence was taken into account, as well as the work group’s evaluation of the applicability of the evidence to develop the strength of each recommendation. The final strength ratings of the 16 recommendations in the Achilles guideline are as follows: Strong, 0; Moderate, 2; Weak, 4; Inconclusive, 8; and Consensus, 2.
Moderate recommendations were given to (1) early (? 2 weeks) postoperative protected weight-bearing for patients with acute Achilles tendon rupture who have been treated operatively, and (2) use of a protective device that allows mobilization by 2-4 weeks postoperatively. It is interesting to note that the guideline provides equal Weak recommendations for treatment of Achilles tendon rupture with and without surgery. This guideline clearly highlights the need for higher Level of Evidence studies on the diagnosis and treatment of acute Achilles tendon ruptures.
The RCT by Willits et al2 is the most recent RCT to attempt to provide a higher Level of Evidence on the treatment of Achilles tendon ruptures. In this study, 144 patients were randomized to operative or non-operative treatment. All patients underwent an accelerated rehabilitation protocol that featured early weight-bearing and early range of motion.
The authors concluded that the application of an accelerated non-operative protocol avoids serious complications related to surgical management with no compromise in strength and re-ruptures rates. This was based on an incidence of two and three re-ruptures in the operative and non-operative groups, respectively, and no clinically important difference between groups for strength, range of motion, calf circumference, and Leppilahti score. Complications were 13% in the operative group and 5% in the non-operative.2
A recent meta-analysis of the literature on treatment of Achilles tendon ruptures provides insight into the efficacy and safety of non-operative treatment. Soroceanu et al3 presented a paper that included eight RCTs that examined surgical treatment (open and minimally invasive) versus conservative treatment initiated within 3 weeks of 369 Achilles tendon ruptures. The analysis concluded that a combination of functional rehabilitation with early range of motion and non-operative treatment should be preferred because surgical repair does not decrease re-rupture rates and is associated with higher complication rates.
In conclusion, there are still no Grade A recommendations on the treatment of Achilles tendon rupture. However, evidence does exist to support both operative and non-operative treatments, with a recent trend of reported success of non-operative treatment. Clearly, there is a need for new high Level of Evidence studies (Level I) on the treatment of Achilles tendon ruptures.
- Chiodo C.P., Glazebrook M., Bluman E.M., et al. Diagnosis and treatment of acute Achilles tendon rupture. J Am Acad Orthop Surg 2010;18-8:503-10.
- Willits K., Amendola A., Bryant D., Giffin R., Mohtadi N. Operative versus non-operative treatment of acute Achilles tendon ruptures: A multicentre randomized trial using accelerated functional rehabilitation. JBJS(A). Vol. Accepted for Publication, 2010.
- Soroceanu A., Feroze S., Shahram A., Kauffman A., Glazebrook M. Operative vs Non-Operative Treatment of Achilles Tendon Ruptures, a Meta-Analysis of Randomized Controlled Trials. Atlantic Provinces Orthopedic Society Annual Meeting. Halifax Nova Scotia, 2010.
Reprinted with permission from the Fall 2010 issue of COA Bulletin