For patients with ruptured Achilles tendons, outcomes at 12 months were similar with surgical or nonsurgical treatment, a new study of nearly 500 individuals shows.

In previous studies, results were comparable after nonoperative and surgical treatment of acute Achilles tendon ruptures. But “these studies have been limited in terms of size and differences in complications, such as reruptures,” said lead author Ståle B. Myhrvold, MD, of the University of Oslo, Norway, in an interview.

“It was, therefore, important to confirm these findings by conducting a sufficiently large randomized controlled trial, which also would allow for the identification of [statistically] significant differences in the risk of complications,” he said. It was important to include minimally invasive treatment because of its potential for reducing the risk of surgical complications, he added.

For the study, which was published in The New England Journal of Medicine, Myhrvold and colleagues recruited adults aged 18 to 60 years who presented with Achilles tendon rupture at four treatment centers in Norway between February 2013 and May 2018.

A total of 554 patients were randomly assigned to undergo open repair, minimally invasive surgery, or nonoperative treatment. The final analysis included 526 patients. The primary outcome was a change from baseline to 12 months in the Achilles tendon Total Rupture Score (ATRS), a patient-reported assessment that comprises 10 questions.

Baseline characteristics were similar across the three groups. The average age of the patients was 39, and approximately three quarters were men. All patients followed a standard rehabilitation protocol.

At 12 months, the change in ATRS score from baseline was similar among the three groups: -17.0 in the nonoperative group, -16.0 in the open-repair group, and -14.7 in the minimally invasive surgery group.

The researchers also evaluated secondary outcomes using the 36-Item Short Form Health Survey at the 6- and 12-month follow-up visits. These scores, which did not differ significantly among the groups, included subscores of physical functioning and physical-component and mental-component summaries.

A total of 11 reruptures occurred in the nonoperative group; one each occurred in the minimally invasive and open-repair groups. No patient experienced more than one rerupture, and half of the reruptures occurred within the first 10 weeks.

However, nerve injuries were significantly less common in the nonoperative group. They were reported in only one patient in that group. By comparison, nine were reported in the minimally invasive surgery group, and five were reported in the open-repair group. Overall, the incidence of other adverse events was similar among the groups.

The lower risk of rerupture in the surgical groups contrasts with results from other studies, the researchers note. “The inconsistent results could be explained by the larger sample size in the present trial, since a meta-analysis that pooled data from 10 randomized, controlled trials and 19 observational studies yielded results similar to those in the present trial,” they write.

Other reasons for the low rerupture risk in the surgical groups may include the use of a modified Krackow suture technique in the open-repair group and the use of three sutures rather than two in the minimally invasive group; both approaches might have provided stronger repairs, they note.

The study findings were limited by several factors, including the lack of blinding for patients to their intervention, which could have led to bias in self-reports of outcomes, and delayed completion of 12-month questionnaires by some patients, the researchers note. The physiotherapists involved in rehabilitation and the physicians who conducted follow-up visits also were not blinded to the treatment assignments, they say.

Despite those limitations, the results suggest that neither open repair or minimally invasive surgery yielded superior outcomes to nonoperative procedures after 12 months, the investigators say. “Nonoperative treatment was associated with a higher risk of rerupture than surgical treatment but resulted in fewer nerve injuries than with minimally invasive surgery,” they conclude.

Myrhvold said he was not surprised by the similarity in outcomes. “We expected that there would be significant differences in rerupture rates and complications related to the surgery because of the large number of included patients, which in fact there were. However, these differences did not affect the overall results,” he said.

The clinical message is that acute Achilles tendon ruptures in adults can be treated nonoperatively and that outcomes are similar to surgical treatments, either open or minimally invasive, said Myrhvold. “There is an increased risk of rerupture after nonoperative treatment, but the total risk of complications (reruptures included) is similar with either treatment,” he said.

As for additional research, subgroup analyses are needed to determine subgroups of patients who benefit from either surgical or nonoperative treatment, which would allow more individualized care, he said. “It is also important to better understand why symptoms and functional limitations persist after treatment and to identify factors that are related to poorer outcomes,” he added.

More Research Needed on Nonoperative Options

Achilles ruptures are a relatively common injury, and the need for surgical treatment is under greater scrutiny, primarily because of cost and potential surgical complications, noted Steven J. Karageanes, DO, a primary care sports medicine specialist in Novi, Michigan, in an interview with Medscape Medical News.

“The findings of this study are in line with prior studies, including a meta-analysis in The BMJ (2019), which found that nonoperative and operative treatments have similar outcomes after 12 months,” said Karageanes.

In the 2019 meta-analysis, “the rerupture rate was significantly higher in the nonoperative group than in either surgical group, while the nerve injury rate was much higher in the minimal invasive surgery group,” Karageanes said. “This gives support to those wanting to avoid surgery, but you run the risk of the tendon failing again. For those wanting surgery, the risk of surgical complications must be considered in the decision-making process.”

He added, “I am disappointed that the study used a standard rehab protocol on everyone, when an accelerated functional rehab protocol used in other studies showed evidence of narrowing the difference in rerupture rates.” The accelerated protocol is described in several studies cited by Myhrvold and his co-authors, Karageanes noted.

“The authors recognize this in their introduction and note that the results of previous studies were inconsistent, but the power of this study offered a solid opportunity to test this hypothesis and potentially help hundreds of patients who may prefer to avoid surgery,” he explained.

“The other issue is that the authors do not classify where exactly the Achilles tears occurred,” said Karageanes. “Tendon tears in the midsubstance of the tendon are more effectively treated by surgical techniques, while tears where the tendon joins the muscle (musculotendinous junction) are not easily treated surgically because of a lack of reliable suture methods. If these are counted within the acute Achilles tears in the study, then the results could be affected,” he said.

Patients with Achilles tendon ruptures should not automatically be referred to surgery, Karageanes said. For each case, consideration should be given to the risks and benefits of surgery.

There is a need for more research on nonoperative rehabilitation for acute Achilles ruptures, he said. “Rerupture is by far the biggest risk of nonoperative treatment, so if a different rehabilitation protocol could negate this rerupture rate difference, then that could dramatically affect many surgical decisions,” he noted.

Nonoperative Complications Raise Methodology Questions

Although many studies have been published comparing operative and nonoperative treatment for Achilles tendon rupture, the current study is an important addition because of its large size and randomized, multicenter design, said Mark Glazebrook, MD, professor of surgery at Dalhousie University, Nova Scotia, Canada, in an interview.

Glazebrook said he was not surprised by the fact that there was no difference in clinical outcomes, as measured by the ATRS. “It is also very important to note that there was no difference early in the recovery period at 3 and 6 months for the Achilles tendon rupture scores as well, suggesting neither treatment modality leads to a faster recovery,” he said.

“However, I was surprised at such a high rate of rerupture, at 6.2% in the nonoperative treatment group,” said Glazebrook. “The complications reporting section also listed deep infections and one complication for nonoperative treatment. While this is possible, it is difficult to understand why no surgery can cause an infection or a wound healing problem,” he noted. “This high rate of rerupture for nonoperative treatment and complications such as deep infections and wound healing problems for nonoperative treatment is not consistent with other high-quality studies previously published and as such draws the methodologies into question,” he added.

The take-home message for clinicians is that, because all three methods of treatment for Achilles tendon ruptures provide similar outcomes, “the patient should be provided with this objective information in an unbiased way to allow them to choose,” said Glazebrook.

However, “The missing research question is, which of these methods return patients to normal activities of daily living and sporting activities at faster rate?” Glazebrook said. “The difficulty with answering this question is choosing a method to measure the return to activities of daily living in sports,” he noted.

The study was supported by the South-Eastern Norway Regional Health Authority and Akershus University Hospital. Myhrvold, Glazebrook, and Karageanes have disclosed no relevant financial relationships.

N Engl J Med. Published online April 13, 2022. Full text

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.

Source: Read Full Article