Nonoperative vs. Surgical Treatment of Acute Achilles’ Tendon Rupture +MP3
Research Review By Dr. Joshua Plener©
Audio:
Date Posted:
October 2022
Study Title:
Nonoperative or Surgical Treatment of Acute Achilles’ Tendon Rupture
Authors:
Myhrbold S, Brouwer E, Andresen T et al.
Author's Affiliations:
Institute of Clinical Medicine, University of Oslo; Department of Orthopaedic Surgery, Akershus University Hospital; Lørenskog, Volvat Medical Center and the Norwegian Sports Medicine Clinic; Division of Orthopedic Surgery and the Oslo Center for Biostatistics and Epidemiology, Oslo University Hospital, Norway
Publication Information:
The New England Journal of Medicine 2022; 386: 1409-20.
Background Information:
Acute Achilles tendon ruptures are one of the most common musculoskeletal injuries and can result in severe disability (1-3). This injury is more common in individuals who are male, older, and more active (4). Randomized clinical trials (RCTs) assessing nonoperative treatment compared to open repair of acute Achilles tendon ruptures have demonstrated similar patient-reported outcomes and physical performance with both approaches (5, 6). A recent systematic review of 10 RCTs and 19 observational studies demonstrated a higher risk of re-rupture after nonoperative treatment, whereas surgical treatment was associated with increased risks of postoperative complications such as infection and nerve injuries (7). However, the trials reviewed were relatively small and protocols of treatment varied or were incompletely described. Studies have suggested that accelerated functional rehab protocols that emphasize early mobilization and weight bearing may lessen the risk of re-rupture after nonoperative treatment (8, 9). To better inform clinical decision making for acute Achilles tendon rupture, these authors conducted a multicenter randomized trial comparing non-operative treatment, open repair, and minimally invasive surgery.
Pertinent Results:
Patients were enrolled from February 2013 through to May 2018, during which time 554 patients underwent randomization, with 492 patients ultimately completing the study. At baseline, the groups were equivalent.
The change in the Achilles’ tendon Total Rupture Score from baseline to the 12-month follow-up was a decrease in 17 points in the nonoperative group, 16 points in the open-repair group and 14.7 points in the minimally invasive surgery group. There were no between group differences in the score reduction. There were also no differences noted in the Achilles’ tendon Total Rupture Score at 3 months and 6 months or in the SF-36 physical and mental-component summaries at 6 months and 12 months.
Serious adverse events occurred in a similar percentage of patients in the three groups. In the non-operative group there were 11 re-ruptures, 1 in the open repair group and 1 in the minimally invasive surgery group. The risk of re-rupture was 5.6% higher in the nonoperative group compared to the open repair and minimally invasive surgery groups and the risk of re-rupture was similar between the two surgical groups. There were 9 nerve injuries in the minimally invasive surgery group compared to 5 in the open-repair group and 1 in the nonoperative group.
The change in the Achilles’ tendon Total Rupture Score from baseline to the 12-month follow-up was a decrease in 17 points in the nonoperative group, 16 points in the open-repair group and 14.7 points in the minimally invasive surgery group. There were no between group differences in the score reduction. There were also no differences noted in the Achilles’ tendon Total Rupture Score at 3 months and 6 months or in the SF-36 physical and mental-component summaries at 6 months and 12 months.
Serious adverse events occurred in a similar percentage of patients in the three groups. In the non-operative group there were 11 re-ruptures, 1 in the open repair group and 1 in the minimally invasive surgery group. The risk of re-rupture was 5.6% higher in the nonoperative group compared to the open repair and minimally invasive surgery groups and the risk of re-rupture was similar between the two surgical groups. There were 9 nerve injuries in the minimally invasive surgery group compared to 5 in the open-repair group and 1 in the nonoperative group.
Clinical Application & Conclusions:
In this large multicenter trial, there were no significant between group differences in changes in the primary and secondary outcomes among patients receiving surgery or nonoperative care for acute Achilles tendon rupture. These findings are similar to those reported in other randomized trials (5, 6).
This trial showed a lower risk of re-rupture in the surgical group compared to the nonoperative group which is a similar finding found in a meta-analysis that pooled 10 RCTs and 19 observational studies (7). In this trial, the risk of re-rupture in the surgical groups were lower than other studies reported. A possible explanation for this is the suture techniques used in the open repair and minimally invasive surgery groups may have provided a stronger repair (10).
Overall, the effectiveness of all three interventions was similar. There was increased risk of re-rupture in the nonoperative group compared to the surgical group but increased risk of nerve injury in the surgical groups compared to the nonoperative group. With this in mind, the decision whether or not to undergo surgery should be made on an individual basis depending, at least in part, on their activity profile or sporting demands in the context of re-rupture risk.
This trial showed a lower risk of re-rupture in the surgical group compared to the nonoperative group which is a similar finding found in a meta-analysis that pooled 10 RCTs and 19 observational studies (7). In this trial, the risk of re-rupture in the surgical groups were lower than other studies reported. A possible explanation for this is the suture techniques used in the open repair and minimally invasive surgery groups may have provided a stronger repair (10).
Overall, the effectiveness of all three interventions was similar. There was increased risk of re-rupture in the nonoperative group compared to the surgical group but increased risk of nerve injury in the surgical groups compared to the nonoperative group. With this in mind, the decision whether or not to undergo surgery should be made on an individual basis depending, at least in part, on their activity profile or sporting demands in the context of re-rupture risk.
Study Methods:
This was a multicenter study conducted through four clinical centres. Patients were assessed for eligibility and included if:
- 18-60 years of age
- Presented with an Achilles tendon rupture to a participating center
- Fluent in Norwegian
Participants were excluded if:
- Previous Achilles’ tendon rupture
- American Society of Anesthesiologists physical status classification was higher than 2 on a 6-point scale, indicating more severe systemic disease
- Recipient of quinolones or local glucocorticoid injection in the 6 months before the injury
- Dependence on walking aids and/or suffering from other disabilities related to walking
Eligible patients were randomly assigned in a 1:1:1 ratio to receive one of the three treatments (nonoperative care, open surgical repair or minimally invasive surgery). Randomization was stratified according to the trial center, with random block sizes of 6, 9, and 12. A below the knee cast was applied within 72 hours after the injury regardless of the treatment group assignment, which was maintained for 2 weeks. After surgery, patients didn’t receive antibiotic prophylaxis. For 6 weeks after the cast was removed, patients could weight bear on the injured foot as tolerated using an ankle foot orthosis with heel wedges. The number of heel wedges gradually reduced from three in the first week to none in the last week.
All patients followed the same standardized rehabilitation protocol which consisted of:
- Weeks 1 and 2: Participants had their foot immobilized in a cast in the equinus position
- Weeks 3 and 4: Participants completed isometric plantar flexion while in the orthosis beginning with 20 repetitions of each exercise performed 3 times each day, in addition to cycling for 10-20 minutes using the orthosis
- Weeks 5 and 6: Participants removed 1 of the 3 heel wedges and performed isometric plantar flexion while in the orthosis, in addition to cycling for 10-20 minutes using the orthosis
- Weeks 7 and 8: Participants removed the 2nd and last heel wedge and performed seated heel raises, mobilization exercises in plantar flexion with a flexed knee, and mobilization exercises in supination/pronation. At week 8, participants completed single leg balance exercises with heel elevation and cycling without the orthosis
- Weeks 9 to 12: Following week 8, participants didn’t wear an orthosis but wore a heel wedge in their shoe for 4 weeks. The exercises included heel raises while standing on both legs gradually increasing their load, neuromuscular balance exercises, cycling with increased load, mobilization exercises in plantar and dorsi flexion with their knee flexed, and dynamic mobility training including stair climbing and squats
- Weeks 13 to 18: Participants continued with strength training gradually increasing their 1 foot heel raise, standing heel raise and seated heel raise, as well as performing ROM exercises and stair climbing
- Weeks 19 to 24: Participants walked for 30 minutes without limping or experiencing pain, performed heel raises with 1 foot while completing toe walking, explosive heel raises, 2-legged jump on their forefoot, and 1 legged jump on their forefoot
- Weeks 25 to 36: Participants performed running exercises, plyometric exercises, strength training, and continued with neuromuscular balance exercises, in addition to returning to sports
The primary outcome was change from baseline to 12-month follow-up in the Achilles tendon Total Rupture Score which is a 10-item patient-reported assessment designed to measure outcomes in patients treated for an acute Achilles’ tendon rupture. Higher scores represent a better health status and the minimal clinically important difference is 8-10 points (11-13). Secondary outcomes included the change in baseline in the Achilles’ tendon total rupture scores at 3- and 6-month follow-ups, change in physical component summary and mental component summary scores of the SF-36, and two different jump tests, two different strength tests and one muscular endurance test (14).
A sample of 480 patients would be needed for a trial with an 80% power and two-sided test with a 5% significance level to detect a difference of 7 points in the Achilles Tendon Total Rupture Score. The primary analysis was performed according to the intention-to-treat principle. If one or more responses were missing on a questionnaire, the score was considered to be missing for that visit. Missed questionnaires at baseline for patients were imputed with the use of median imputation. Adverse events were registered until trial closure for all participants.
A sample of 480 patients would be needed for a trial with an 80% power and two-sided test with a 5% significance level to detect a difference of 7 points in the Achilles Tendon Total Rupture Score. The primary analysis was performed according to the intention-to-treat principle. If one or more responses were missing on a questionnaire, the score was considered to be missing for that visit. Missed questionnaires at baseline for patients were imputed with the use of median imputation. Adverse events were registered until trial closure for all participants.
Study Strengths / Weaknesses:
Strengths:
- The physiotherapists who performed the physical tests were unaware of the treatment group assignment.
- This study adds to this body of literature and is the largest trial on this topic conducted to date.
Weaknesses:
- Patients and physicians were aware of their assigned intervention which could introduce bias. However, this was done for feasibility reasons.
Additional References:
- Huttunen TT, Kannus P, Rolf C, Fellander-Tsai L, Mattila VM. Acute achilles tendon ruptures: incidence of injury and surgery in Sweden between 2001 and 2012. Am J Sports Med 2014; 42: 2419-23.
- Sheth U, Wasserstein D, Jenkinson R, Moineddin R, Kreder H, Jaglal SB. The epidemiology and trends in management of acute Achilles tendon ruptures in Ontario, Canada: a population-based study of 27 607 patients. Bone Joint J 2017; 99-B: 78-86.
- Ganestam A, Kallemose T, Troelsen A, Barfod KW. Increasing incidence of acute Achilles tendon rupture and a noticeable decline in surgical treatment from 1994 to 2013: a nationwide registry study of 33,160 patients. Knee Surg Sports Traumatol Arthrosc 2016; 24: 3730-7.
- Noback PC, Jang ES, Cuellar DO, et al. Risk factors for achilles tendon rupture: a matched case control study. Injury 2017; 48: 2342-7.
- Nilsson-Helander K, Silbernagel KG, Thome. R, et al. Acute achilles tendon rupture: a randomized, controlled study comparing surgical and nonsurgical treatments using validated outcome measures. Am J Sports Med 2010; 38: 2186-93.
- Olsson N, Silbernagel KG, Eriksson BI, et al. Stable surgical repair with accelerated rehabilitation versus nonsurgical treatment for acute Achilles tendon ruptures: a randomized controlled study. Am J Sports Med 2013; 41: 2867-76.
- Ochen Y, Beks RB, van Heijl M, et al. Operative treatment versus nonoperative treatment of Achilles tendon ruptures: systematic review and meta-analysis. BMJ 2019; 364: k5120.
- Twaddle BC, Poon P. Early motion for Achilles tendon ruptures: is surgery important? A randomized, prospective study. Am J Sports Med 2007; 35: 2033-8.
- Soroceanu A, Sidhwa F, Aarabi S, Kaufman A, Glazebrook M. Surgical versus nonsurgical treatment of acute Achilles tendon rupture: a meta-analysis of randomized trials. J Bone Joint Surg Am 2012; 94: 2136-43.
- Labib SA, Rolf R, Dacus R, Hutton WC. The “Giftbox” repair of the Achilles tendon: a modification of the Krackow technique. Foot Ankle Int 2009; 30: 410-4.
- Costa ML, Achten J, Marian IR, et al. Plaster cast versus functional brace for non-surgical treatment of Achilles tendon rupture (UKSTAR): a multicentre randomized controlled trial and economic evaluation. Lancet 2020; 395: 441-8.
- Westin O, Sj.gren T, Svedman S, et al. Treatment of acute Achilles tendon rupture — a multicentre, non-inferiority analysis. BMC Musculoskelet Disord 2020; 21: 358.
- Nilsson-Helander K, Thome. R, Silbernagel KG, et al. The Achilles tendon Total Rupture Score (ATRS): development and validation. Am J Sports Med 2007; 35: 421-6.
- Silbernagel KG, Gustavsson A, Thome. R, Karlsson J. Evaluation of lower leg function in patients with Achilles tendinopathy. Knee Surg Sports Traumatol Arthrosc 2006; 14: 1207-17.
