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Completed

NCT Number: NCT04955665

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

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.

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Key information

Conditions

Recurrent Peroneal Tendon Dislocation

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

bone block procedure

Procedure

a 20 × 15 × 3 mm3 bone block was cut from the lateral malleolus, rotated backwards 45°, and sutured back to the periosteum of the lateral malleolus using non-absorbable sutures.

Reattachment of the superior peroneal retinaculum

Procedure

two suture anchors (Mini Quickanchor,DePuy Mitek) were inserted into the postero-lateral ridge of the lateral malleolus without damaging the cartilaginous ridge, after which the SPR was reattached to the lateral malleolus with the anchored suture. The inner layer of the false pouch was incised, and the outer layer (periosteum) was sutured with the SPR in a pants-over-vest style.

Primary outcomes

  1. AOFAS

    Time frame: 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 outcomes

  1. VAS

    Time frame: 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.

  2. time to return to sports activity

    Time frame: up to 2 years

    time to return to sports activity after surgery at each group

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

The Clinical Efficacy of Reattachment of the Superior Peroneal Retinaculum Versus the Bone Block Procedure for Recurrent Peroneal Tendon Dislocation

Important dates

Study start
2012
Primary completion
2016
Study completion
2018
First posted
Jul 9, 2021
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.