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

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04955665
Collaborator
(none)
47
78

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: bone block procedure
  • Procedure: Reattachment of the superior peroneal retinaculum

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 Design

Study Type:
Observational
Actual Enrollment :
47 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Clinical Efficacy of Reattachment of the Superior Peroneal Retinaculum Versus the Bone Block Procedure for Recurrent Peroneal Tendon Dislocation
Actual Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Dec 31, 2016
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Bone block procedure

patients with recurrent peroneal tendon dislocation underwent the bone block procedure

Procedure: bone block 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

patients with recurrent peroneal tendon dislocation underwent reattachment of the superior peroneal retinaculum

Procedure: Reattachment of the superior peroneal retinaculum
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. time to return to sports activity [up to 2 years]

    time to return to sports activity after surgery at each group

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Study Chair: Qinwei Guo, MD, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04955665
Other Study ID Numbers:
  • M2018225
First Posted:
Jul 9, 2021
Last Update Posted:
Jul 9, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2021