Ankle SprainNCT06897293
Comparison of MBR + Suture Tape and MBR for CLAI : A Prospective Cohort Study
An observational study of Ankle Sprain and Hypermobility, Joint, run by Peking University Third Hospital at 1 site in China.
Trial summary
GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. Additional suture tape augmentation has been suggested to provide more strength and stability. However, the outcomes of the MBP with suture tape augmentation were unknown, which requires further exploration. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Ankle Sprain, Hypermobility, Joint
- What is being tested?
- Modified Broström procedure + Suture tape augmentation operation and Modified Broström procedure operation
- Type of treatment
- Surgery or procedure
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The patients who go to visit a doctor for persistent lateral ankle pain and instability over three months and invalid conservative treatment, with the age of 15 - 55 years. If the Beighton score of the patient is ≥4 and the exclusion criteria are met, he or she is going to be advised to participate in this study.
Who may be able to join
- Clinical diagnosis of lateral ankle instability
- Beighton score ≥4
- Age with 18 to 60 years
Who cannot join
- Patients with an acute or subacute ankle injury
- Injury of the deltoid ligament
- Alignment of lower extremity greater than 5 degrees
- Fractures of the lower extremity
- Stage III or IV osteoarthritis
- Patients who refused to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Dong Jiang, MD, 13811280948, bysyjiangdong@126.com
About this study
Official title: Comparison of Modified Broström Repair + Suture Tape and Modified Broström Repair for Chronic Lateral Ankle Instability : A Prospective Cohort Study
GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. Additional suture tape augmentation has been suggested to provide more strength and stability. However, the outcomes of the MBP with suture tape augmentation were unknown, which requires further exploration.
Read the detailed description
Generalized joint laxity (GJL) is a risk factor for postoperative recurrent instability following an open modified Broström repair (MBR) for chronic lateral ankle instability (CLAI). MBR with suture tape augmentation may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape. In addition, the outcomes of the MBP with suture tape augmentation were unknown.
- Conditions
- Ankle Sprain, Hypermobility, Joint
- Being tested
- Modified Broström procedure + Suture tape augmentation operation, Modified Broström procedure operation
- Medical subject headings
- Ankle Injuries, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Broström procedure + Suture tape augmentation operationProcedure or surgery
Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation
Modified Broström procedure operationProcedure or surgery
Patients with CLAI and GJL will accept the Modified Broström procedure operation
| Study group | Role | What they receive |
|---|---|---|
| Open Modified Broström +Suture tape augmentation group | Patients who accept a modified Broström procedure + Suture tape augmentation operation Receives: Procedure: Modified Broström procedure + Suture tape augmentation operation | |
| Open Modified Broström group | Patients who accept a modified Broström procedure operation Receives: Procedure: Modified Broström procedure operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The American Orthopaedic Foot and Ankle Society (AOFAS) score
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
Measured: postoperative AOFAS score at 1 year
The American Orthopaedic Foot and Ankle Society (AOFAS) score
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
Measured: postoperative AOFAS score at 2 years
The American Orthopaedic Foot and Ankle Society (AOFAS) score
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
Measured: postoperative AOFAS score at 6 months
The American Orthopaedic Foot and Ankle Society (AOFAS) score
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
Measured: postoperative AOFAS score at 3 months
Secondary outcomes (2)
Anterior displacement and talar tilt angle in stress radiography
The outcomes are common indicators for evaluation the lateral stability of ankle, and can be evaluated through same stress radiography
Measured: postoperative radiographic measures at 2 years
Rate of re-injury
The rate of patients re-sprain after the surgery
Measured: the rate of re-injury at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Jun 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainStudies 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
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Dong, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897293
- Sponsor's protocol ID
- M2024292
- Status last verified
- May 2026
- First submitted
- 13 Mar 2025
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers
Publications
Wittig U, Hohenberger G, Ornig M, Schuh R, Reinbacher P, Leithner A, Holweg P. Improved Outcome and Earlier Return to Activity After Suture Tape Augmentation Versus Brostrom Repair for Chronic Lateral Ankle Instability? A Systematic Review. Arthroscopy. 2022 Feb;38(2):597-608. doi: 10.1016/j.arthro.2021.06.028. Epub 2021 Jul 9.
PubMed 34252562Xu HX, Lee KB. Modified Brostrom Procedure for Chronic Lateral Ankle Instability in Patients With Generalized Joint Laxity. Am J Sports Med. 2016 Dec;44(12):3152-3157. doi: 10.1177/0363546516657816. Epub 2016 Aug 5.
PubMed 27496909
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Modified Broström Repair + Suture Tape and Modified Broström Repair for Chronic Lateral Ankle Instability : A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06897293
- Acronym / sponsor ID
- M2024292
- Conditions
- Ankle Sprain, Hypermobility, Joint
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 26 Mar 2025 (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.
GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. Additional suture tape augmentation has been suggested to provide more strength and stability. However, the outcomes of the MBP with suture tape augmentation were unknown, which requires further exploration.
Detailed description
Generalized joint laxity (GJL) is a risk factor for postoperative recurrent instability following an open modified Broström repair (MBR) for chronic lateral ankle instability (CLAI). MBR with suture tape augmentation may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape. In addition, the outcomes of the MBP with suture tape augmentation were unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Modified Broström +Suture tape augmentation group | – | Procedure: Modified Broström procedure + Suture tape augmentation operationPatients who accept a modified Broström procedure + Suture tape augmentation operation |
| Open Modified Broström group | – | Procedure: Modified Broström procedure operationPatients who accept a modified Broström procedure operation |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The patients who go to visit a doctor for persistent lateral ankle pain and instability over three months and invalid conservative treatment, with the age of 15 - 55 years. If the Beighton score of the patient is ≥4 and the exclusion criteria are met, he or she is going to be advised to participate in this study.
Key inclusion criteria (3 listed)
- Clinical diagnosis of lateral ankle instability
- Beighton score ≥4
- Age with 18 to 60 years
Key exclusion criteria (6 listed)
- Patients with an acute or subacute ankle injury
- Injury of the deltoid ligament
- Alignment of lower extremity greater than 5 degrees
- Fractures of the lower extremity
- Stage III or IV osteoarthritis
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 |
|---|---|---|
| Modified Broström procedure + Suture tape augmentation operationPatients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation | Procedure or surgery | Open Modified Broström +Suture tape augmentation group |
| Modified Broström procedure operationPatients with CLAI and GJL will accept the Modified Broström procedure operation | Procedure or surgery | Open Modified Broström group |
Primary outcome
The American Orthopaedic Foot and Ankle Society (AOFAS) score
Time frame: postoperative AOFAS score at 1 year
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
The American Orthopaedic Foot and Ankle Society (AOFAS) score
Time frame: postoperative AOFAS score at 2 years
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
The American Orthopaedic Foot and Ankle Society (AOFAS) score
Time frame: postoperative AOFAS score at 6 months
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
The American Orthopaedic Foot and Ankle Society (AOFAS) score
Time frame: postoperative AOFAS score at 3 months
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
2 secondary outcomes
Anterior displacement and talar tilt angle in stress radiography
Time frame: postoperative radiographic measures at 2 years
Rate of re-injury
Time frame: the rate of re-injury at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Results publication: PubMed 34252562Wittig U, Hohenberger G, Ornig M, Schuh R, Reinbacher P, Leithner A, Holweg P. Improved Outcome and Earlier Return to Activity After Suture Tape Augmentation Versus Brostrom Repair for Chronic Lateral Ankle Instability? A Systematic Review. Arthroscopy. 2022 Feb;38(2):597-608. doi: 10.1016/j.arthro.2021.06.028. Epub 2021 Jul 9.
- Results publication: PubMed 27496909Xu HX, Lee KB. Modified Brostrom Procedure for Chronic Lateral Ankle Instability in Patients With Generalized Joint Laxity. Am J Sports Med. 2016 Dec;44(12):3152-3157. doi: 10.1177/0363546516657816. Epub 2016 Aug 5.
- Individual participant dataSharing planned: Yes. The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers
Related trials for Ankle Sprain
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Sprain and Hypermobility, Joint, run by Peking University Third Hospital at 1 site in China.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Jiang, MD (13811280948, bysyjiangdong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The American Orthopaedic Foot and Ankle Society (AOFAS) score (time frame: postoperative AOFAS score at 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06897293, which also lists 2 linked publications.
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 20 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.