Recurrent Peroneal Tendon DislocationNCT04955665
Reattachment of the SPR Versus the Bone Block Procedure for Recurrent Peroneal Tendon Dislocation
An observational study of Recurrent Peroneal Tendon Dislocation, run by Peking University Third Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Peroneal Tendon Dislocation
- What is being tested?
- bone block procedure and Reattachment of the superior peroneal retinaculum
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2012to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A consecutive series of patients with recurrent peroneal tendon dislocation who underwent operative treatment between 2012 and 2016 were retrieved. Twenty-five patients underwent bone block procedure (group A), and 22 patients underwent reattachment of the SPR (group B)."
Who may be able to join
- a traumatic recurrent peroneal tendon dislocation requiring surgery
- a lack of response to at least 3 months of conservative treatment
Who cannot join
- the presence of an acute peroneal tendon dislocation
- a concomitant anterior talofibular ligament rupture
About this study
Official title: The Clinical Efficacy of Reattachment of the Superior Peroneal Retinaculum 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.
Read the 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.
- Conditions
- Recurrent Peroneal Tendon Dislocation
- Being tested
- bone block procedure, Reattachment of the superior peroneal retinaculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone block procedureProcedure or surgery
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 retinaculumProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Bone block procedure | patients with recurrent peroneal tendon dislocation underwent the bone block procedure Receives: Procedure: bone block procedure | |
| Reattachment of the superior peroneal retinaculum | patients with recurrent peroneal tendon dislocation underwent reattachment of the superior peroneal retinaculum Receives: Procedure: Reattachment of the superior peroneal retinaculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS
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.
Measured: 2 years after operation
Secondary outcomes (2)
VAS
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.
Measured: 2 years after operation
time to return to sports activity
time to return to sports activity after surgery at each group
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Jul 2012
- Primary completion31 Dec 2016
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Peroneal Tendon DislocationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qinwei Guo, MD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955665
- Sponsor's protocol ID
- M2018225
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Reattachment of the Superior Peroneal Retinaculum Versus the Bone Block Procedure for Recurrent Peroneal Tendon Dislocation
- ClinicalTrials.gov ID
- NCT04955665
- Acronym / sponsor ID
- M2018225
- Conditions
- Recurrent Peroneal Tendon Dislocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone block procedure | – | Procedure: bone block procedurepatients with recurrent peroneal tendon dislocation underwent the bone block procedure |
| Reattachment of the superior peroneal retinaculum | – | Procedure: Reattachment of the superior peroneal retinaculumpatients with recurrent peroneal tendon dislocation underwent reattachment of the superior peroneal retinaculum |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A consecutive series of patients with recurrent peroneal tendon dislocation who underwent operative treatment between 2012 and 2016 were retrieved. Twenty-five patients underwent bone block procedure (group A), and 22 patients underwent reattachment of the SPR (group B)."
Key inclusion criteria (2 listed)
- a traumatic recurrent peroneal tendon dislocation requiring surgery
- a lack of response to at least 3 months of conservative treatment
Key exclusion criteria (2 listed)
- the presence of an acute peroneal tendon dislocation
- a concomitant anterior talofibular ligament rupture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone block procedurea 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. | Procedure or surgery | Bone block procedure |
| Reattachment of the superior peroneal retinaculumtwo 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. | Procedure or surgery | Reattachment of the superior peroneal retinaculum |
Primary outcome
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.
2 secondary outcomes
VAS
Time frame: 2 years after operation
time to return to sports activity
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qinwei Guo, MD study chair
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Peroneal Tendon Dislocation, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS (time frame: 2 years after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.