Abstract
BackgroundWhile numerous clinical studies have compared the surgical and non-surgical treatment of acute Achilles tendon rupture (ATR), there are no studies that have performed a non-inferiority analysis between treatments.MethodsData from patients who were included in five randomised controlled trials from two different centres in Sweden were used. Outcomes at 1 year after ATR consisted of the patient-reported Achilles tendon Total Rupture Score (ATRS) and the functional heel-rise tests reported as the limb symmetry index (LSI). The non-inferiority statistical 10% margin was calculated as a reflection of a clinically acceptable disadvantage in ATRS and heel-rise outcome when comparing treatments.ResultsA total of 422 patients (350 males and 72 females) aged between 18 and 71 years, with a mean age of 40.6 (standard deviation 8.6), were included. A total of 363 (86%) patients were treated surgically. The ATRS (difference (Δ) = − 0.253 [95% confidence interval (CI); − 5.673;5.785] p = 0.36) and LSI of heel-rise height (difference = 1.43 [95% CI; − 2.43;5.59] p = 0.81), total work (difference = 0.686 [95% CI; − 4.520;6.253] p = 0.67), concentric power (difference = 2.93 [95% CI; − 6.38;11.90] p = 0.063) and repetitions (difference = − 1.30 [95% CI; − 6.32;4.13] p = 0.24) resulted in non-inferiority within a Δ − 10% margin for patients treated non-surgically.ConclusionThe non-surgical treatment of Achilles tendon ruptures is not inferior compared with that of surgery in terms of 1-year patient-reported and functional outcomes.
Highlights
While numerous clinical studies have compared the surgical and non-surgical treatment of acute Achilles tendon rupture (ATR), there are no studies that have performed a non-inferiority analysis between treatments
It has been indicated that patients undergoing surgical treatment for Achilles tendon rupture have superior functional performance in heel-rise tests compared with patients treated non-surgically, possibly owing to a reduced risk of tendon elongation with this treatment [5]
This randomised, non-inferior study based on a pooled sample of 422 patients is the first investigation to demonstrate that non-surgical treatment is non-inferior to surgical treatment 1 year after Achilles tendon rupture with regard to the Achilles tendon Total Rupture Score (ATRS) and limb symmetry index (LSI) in the heel-rise tests for concentric power, heel-rise height, total work and heel-rise repetitions
Summary
While numerous clinical studies have compared the surgical and non-surgical treatment of acute Achilles tendon rupture (ATR), there are no studies that have performed a non-inferiority analysis between treatments. It has been indicated that patients undergoing surgical treatment for Achilles tendon rupture have superior functional performance in heel-rise tests compared with patients treated non-surgically, possibly owing to a reduced risk of tendon elongation with this treatment [5]. There is no study that has used a non-inferiority design to evaluate outcome after treatment in patients who have suffered an acute Achilles tendon rupture. In terms of this study, a non-inferiority analysis aimed to test whether the outcome of non-surgical treatment was not unacceptably inferior to the outcome of the surgical treatment This is important, as non-surgical treatment still offers a safer, more cost-effective treatment option, despite having slightly poorer efficacy with regard to a higher incidence of re-rupture and a prolonged time to regain preinjury function compared with the surgical treatment [7]. The non-surgical treatment may still be acceptable due to other advantages if one is willing to sacrifice some degree of benefit relative to the surgical treatment [6]
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