Flexor Tendon Tenotomy Treatment of the Diabetic Foot: A Multicenter Randomized Controlled Trial

Abstract

OBJECTIVE The aim of this study was to evaluate the effects of needle flexor tendon tenotomy treatment of the diabetic hammertoe deformity. RESEARCH DESIGN AND METHODS A multicenter randomized controlled trial of individuals with diabetes and ulcers or impending ulcers associated with hammertoes was performed between 1 November 2019 and 31 March 2021. Participants were stratified by the presence of ulcers or impending ulcers. Participants were randomly assigned to tenotomy and standard nonsurgical treatment or to standard nonsurgical treatment alone. Primary outcomes were time to ulcer healing and progression from impending ulcer to active ulcer. RESULTS Of 224 screened participants with diabetes, 95 (59.0% men) were included. The mean follow-up was 291 ± 70 days, 28 (29.5%) had type 1 diabetes, mean diabetes (presented with 25–75% quartile) duration was 20 (13–26) years, and mean age was 67.7 ± 9.8 years. Of the included participants, 16 had ulcers, of whom 8 were randomly assigned to intervention. Of the remaining 79 with impending ulcers, 39 were randomly assigned to intervention. For participants with ulcers, healing rates favored tenotomy (100% vs 37.5%, P = 0.026) as did time to ulcer healing (P = 0.04). For those with impending ulcers, incidence of progression to an active ulcer was lower (1 vs 7, P = 0.028) and the number of ulcer-free days higher (P = 0.043) in the tenotomy group. No serious adverse events were recorded. CONCLUSIONS This randomized study showed that the simple procedure of needle flexor tendon tenotomy was effective and safe when treating and preventing ulcers associated with the diabetic hammertoe deformity.

Effectiveness of Percutaneous Flexor Tenotomies for the Prevention and Management of Toe-Related Diabetic Foot Ulcers: A Systematic Review

“…Among the included literature, ten studies were case series studies, of which seven were retrospective [17][18][19][20][21][22][23] and three prospective [24][25][26]. One randomized clinical trial was also assessed [27]. The eleven studies included 770 flexor tenotomies performed in diabetic patients.…”

“…The studies included patients who had undergone FT to treat one or more lesions located in the apex of the toes associated with a flexible or semi-flexible digital deformity, The studies included patients who had undergone FT to treat one or more lesions located in the apex of the toes associated with a flexible or semi-flexible digital deformity, except for the RCT by Andersen et al [27] and the study by Smith et al [24], in which participants with rigid digital deformities were not excluded.…”

“…Regarding the surgical procedure technique, there were studies in which only the flexor digitorum longus was sectioned [17,21,22] and others in which the flexor digitorum longus and flexor digitorum brevis were approached together [17,19,20,26,27], with the incision placed proximally or distally depending on the approach. The tenotomy was performed with a scalpel [17][18][19][20][21][22]24,26]; in some cases, a percutaneous needle was used [23][24][25]27].…”

“…Post-surgical follow-up time ranged from 6 [19,24] to 28 months [18]; five studies followed patients for around 1 year [17,22,[25][26][27], and three articles followed patients for approximately 2 years [19,21,23]. The research characteristics are shown in Table 1.…”

The efficacy of flexor tenotomy to prevent recurrent diabetic foot ulcers (DIAFLEX trial): Study protocol for a randomized controlled trial

“…The beneficial effects of flexor tenotomy in people with diabetes and claw/hammer toe deformity have been investigated in retrospective and prospective case series [ [16] , [17] , [18] , [19] , [20] , [21] , [22] ]. Currently, one randomized controlled trial is being conducted and one was published in September 2022 [ 23 , 24 ]. However, there is still need for more evidence to further substantiate the benefits of flexor tenotomy as well as the need for evaluation in a controlled study design of changes in the biomechanical and musculoskeletal structure of the foot due to the flexor tenotomy.…”