Reattachment of the SPR Versus the Bone Block Procedure for Recurrent Peroneal Tendon Dislocation

Completed

• Conditions: Recurrent Peroneal Tendon Dislocation
• Interventions: Procedure: bone block procedure; Procedure: Reattachment of the superior peroneal retinaculum

• Registration Number: NCT04955665
• Lead Sponsor: Peking University Third Hospital

Brief Summary

Clinical outcomes between reattachment of the superior peroneal retinaculum (SPR) and the bone block procedure were compared in this study to elucidate which procedure was safer and more effective.

Detailed Description

From 2012 to 2016, 25 patients with recurrent peroneal tendon dislocation underwent the bone block procedure(group A), and another 22 patients underwent reattachment of the SPR (group B). American Orthopaedic Foot and Ankle society (AOFAS) ankle-hindfoot score, Ankle Activity Score (AAS), time to return to sports activity, rate of return to sports level, range of motion (ROM) of the ankle, rate of recurrence, and overall patient satisfaction were collected to evaluate outcomes between the two groups.

Study Timeline

• Study Start: 2012-07-01
• Primary Completion: 2016-12-31
• Study Completion: 2018-12-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Study First Posted: 2021-07-09
• Last Update Posted: 2021-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• a traumatic recurrent peroneal tendon dislocation requiring surgery
• a lack of response to at least 3 months of conservative treatment

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Exclusion Criteria

• the presence of an acute peroneal tendon dislocation
• a concomitant anterior talofibular ligament rupture

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bone block procedure	bone block procedure	patients with recurrent peroneal tendon dislocation underwent the bone block procedure
Reattachment of the superior peroneal retinaculum	Reattachment of the superior peroneal retinaculum	patients with recurrent peroneal tendon dislocation underwent reattachment of the superior peroneal retinaculum

Primary Outcome Measures

Name	Time	Method
AOFAS	2 years after operation	The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). The minimum and maximum values of AOFAS are 100 and 0, respectively. And higher scores mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
VAS	2 years after operation	The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. The minimum and maximum values of VAS are 10 and 0, respectively. And higher scores mean a worse outcome.
time to return to sports activity	up to 2 years	time to return to sports activity after surgery at each group