Device is alternative to suture repair of zone 2 flexor digitorum profundus tendons
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A coupler device designed to mitigate the risk of repair rupture after zone 2 flexor tendon repairs was associated with range of motion and functional outcome scores similar to sutures, but had a lower rupture rate, a presenter said.
Gaps of 2 mm or more can lead to tendon rerupture after these kinds of repairs, according to Melvin P. Rosenwasser, MD, who presented results of a multicenter, prospective randomized trial of the CoNextions TR Tendon Repair System (CoNextions Medical) vs. standard suture repair at the American Society for Surgery of the Hand Annual Meeting.
“The new stapling or coupling option allows 64 N before a gap formation occurs, and that has to do with the uniqueness of the grasping of the tendon ends with these interfolding staples,” Rosenwasser said of the new device.
The study was conducted in South Africa and patients and evaluators were blinded to treatment. Ninety patients were randomized to undergo repair of lacerated zone 2 flexor digitorum profundus tendons with either the stainless steel and polyethylene coupling device or four-strand locked cruciate suture repair, which was the control procedure.
Patients were followed for 24 weeks. A primary analysis was done at 12 weeks, Rosenwasser said.
“The outcomes of the randomized trial showed that range of motion and functional outcome scores were equivalent to suture repair. However, the rupture rates were markedly less, with only 2% rupture in the coupler group and 10% rupture in the suture repair group,” he said. “In addition, as far as the safety follow-up, the infection rates seem to be four times as great in the suture group compared to the coupler group.”
Per the abstract, the rate of surgical site infection was 2.7% in the device group and 11.11% in the control group.
Rosenwasser said the FDA has not yet approved the CoNextions TR Tendon Repair System.
“This paper is significant because it introduces a new tendon repair device for flexor tendons lacerated in the hand and even more importantly, zone 2, which is called ‘no man’s land.’ This phrase has been utilized to highlight the variable and often poor results of flexor tendon repair in this anatomic region,” Rosenwasser told Healio Orthopedics.
“Patients were followed for 12 weeks and the results demonstrated less tendon ruptures and less surgical site infections in the new surgical stapling device cohort with 1/51 tendons ruptured in the stapling group and 6/61 tendons ruptured in the control suture group. Surgical site infections were also differentiated with 1/37 patients with surgical site infection in the stapling group and 5/45 with surgical site infection in the control suture group,” Rosenwasser continued. “These results are promising and may allow more aggressive active motion protocols while limiting tendon repair rupture.”
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Rosenwasser MP, et al. Paper 35 Presented at: American Society for Surgery of the Hand Annual Meeting. Sept.30 - Oct. 2, 2021; San Francisco (hybrid meeting).
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