麻豆传媒

For Achilles' tendon rupture, surgery didn't improve outcomes more than other kinds of treatment, a randomized trial showed.

At 12 months, patient-reported symptoms and physical activity were similar in both the open-repair and minimally invasive surgery groups as well as in the nonoperative group, with mean improvements on the 100-point Achilles' tendon Total Rupture Score scale of 17.0, 16.0, and 14.7 points, respectively (P=0.57).

None of the differences between groups in that primary endpoint nor in the secondary endpoints of physical performance and patient-reported physical function were statistically significant, reported Ståle Myhrvold, MD, of the Orthopedic Clinic at Akershus University Hospital in Lørenskog, Norway, and colleagues, writing in the .

The findings overall were consistent with the results of most previous randomized, controlled trials, which were smaller and not powered to find a difference in the range of the 8-10 point minimal clinically meaningful difference on the Achilles' tendon Total Rupture Score scale, the researchers noted.

However, the nonoperative group in Myhrvold's trial had more tendon reruptures (6.2% vs 0.6% in both of the operative groups).

That substantial difference in rerupture despite all patients having received dynamic rehabilitation "addresses an ongoing controversy regarding whether dynamic rehabilitation reduces the risk of rerupture in patients who are treated nonoperatively," according to an .

"In light of the results of the present trial and previous trials, the message is now clear: Surgery substantially lowers the risk of rerupture, and dynamic rehabilitation does not," wrote Kristoffer Barfod, MD, PhD, and Per Hölmich, DMSc, both of the Copenhagen University Hospital Amager–Hvidovre in Denmark.

There's no good way to predict who is at high risk of rerupture, they pointed out.

One possible explanation for the between-group differences in rerupture was "the use of a modified Krackow suture technique in the open-repair group in this trial, which may have provided a stronger repair," the researchers suggested. "Surgeons also used three sutures instead of two sutures in the minimally invasive surgery group, although there is no direct evidence indicating that this technique increases biomechanical strength."

Notably, these good outcomes across the board were achieved "in the context of a structured rehabilitation protocol with close follow-up of all patients," the editorialists highlighted. "This level of control may be difficult to reproduce in clinical practice, which may constitute a particular problem for nonoperative patients since both surgeons and patients may better understand the severity of an injury that is treated surgically."

On the other hand, nerve injury occurred in 5.2% of patients getting minimally invasive surgery (nine cases), compared with 2.8% (five cases) in the open-repair patients and 0.6% (one) in the patients who didn't get surgery.

"Until evidence-based guidance for individualized treatment selection is available, the choice of treatment should be based on shared decision making that weighs the benefits of avoiding surgery against the higher risk of tendon rerupture," Barfod and Hölmich concluded.

The trial included 554 patients ages 18 to 60 who presented with Achilles' tendon rupture at four centers. The patients were randomized 1:1:1 to open repair, minimally invasive surgical repair, or nonoperative treatment.

All groups got a below-the-knee equinus cast (with plantar flexion) within 72 hours after the injury that was kept on for 2 weeks in the nonoperative group whereas the surgical groups got a new cast after surgery that they maintained for 2 weeks. After getting the cast off, patients were allowed to bear weight on the injury as tolerated for the next 6 weeks with an ankle-foot orthosis with heel wedges (gradually reduced from three to none). Patients were instructed to do isometric exercises starting 3 weeks after rupture.

Exclusion criteria included previous Achilles' tendon rupture, the American Society of Anesthesiologists physical status classification higher than II, the receipt of quinolones, glucocorticoid injections in the area of the Achilles' tendon in the 6 months before the injury, dependence on walking aids, and other disabilities that would impact walking.

"Of note, this trial did not include patients with overlooked ruptures or reruptures, both of which are injuries that are considered to benefit from surgery; surgery may also be preferred in high-level athletes," the editorialists noted.

Three- and 6-month findings were similar to those at 12 months. Median time from injury to completion of the final questionnaire was 1.1 years.

One limitation highlighted by the researchers was: "Although physiotherapists who performed physical tests were unaware of treatment-group assignments, patients were not unaware of their assignments, nor were the physicians who conducted follow-up visits or the physiotherapists involved in rehabilitation; thus, bias is possible in patient self-reporting of outcomes or in the implementation of accelerated functional rehabilitation."

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