Ankle SprainsNCT05698446
Comparison of MBR + Suture Tape, MBR, and Anatomic Reconstruction for CLAI in GJL Cases: A Prospective Cohort Study
An observational study of Ankle Sprains and Hypermobility Syndrome, 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. BPR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankle Sprains, Hypermobility Syndrome
- What is being tested?
- Modified Broström + Suture tape augmentation operation, Anatomic reconstruction operation and Open Modified Broström procedure
- Type of treatment
- Surgery or procedure
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Jun 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- 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 18- 60 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 pain and instability Beighton score ≥4 Age with 18 to 60 years
Who cannot join
- Patients with an acute or subacute ankle injury (within 3 months) 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
Dong Jiang, MD, 13811280948, bysyjiangdong@126.com
About this study
Official title: Comparison of Modified Broström Repair + Suture Tape and Anatomic Reconstruction for CLAI in Chronic Lateral Ankle Instability in Generalized Joint Laxity Cases: A Prospective Cohort Study
GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. BPR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.
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 and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.
- Conditions
- Ankle Sprains, Hypermobility Syndrome
- Being tested
- Modified Broström + Suture tape augmentation operation, Anatomic reconstruction operation, Open Modified Broström procedure
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Broström + Suture tape augmentation operationProcedure or surgery
Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation
Anatomic reconstruction operationProcedure or surgery
Anatomic reconstruction operation
Open Modified Broström procedureProcedure or surgery
Open Modified Broström-Gould surgery
| Study group | Role | What they receive |
|---|---|---|
| Open Modified Broström +Suture tape augmentation group | Patients who accept a modified Broström +Suture tape augmentation operation Receives: Procedure: Modified Broström + Suture tape augmentation operation | |
| Anatomic reconstruction operation group | Patients who accept an anatomic reconstruction Receives: Procedure: Anatomic reconstruction operation | |
| Open Modified Broström group | Patients who under went open Modified Broström-Gould surgery Receives: Procedure: Open Modified Broström procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Karlsson-Peterson score
This score is a primary scale for lateral ankle instability, with a maximum value of 100 and minimum value of 0. Larger Karlsson-Peterson score represents better ankle functional outcomes.
Measured: postoperative Karlsson score at 1 year
Karlsson-Peterson score
This score is a primary scale for lateral ankle instability, with a maximum value of 100 and minimum value of 0. Larger Karlsson-Peterson score represents better ankle functional outcomes.
Measured: postoperative Karlsson score at 2 years
Secondary outcomes (1)
Anterior displacement and talar tilt angle in stress radiography
The outcomes are common indicators for evaluation the lateral stability of ankle
Measured: postoperative radiographic measures 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 Jan 2023
- Study start1 Nov 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainsStudies 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
- 114 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
- NCT05698446
- Sponsor's protocol ID
- M2022514
- Status last verified
- Mar 2025
- First submitted
- 16 Jan 2023
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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
Xu 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 27496909Sacks HA, Prabhakar P, Wessel LE, Hettler J, Strickland SM, Potter HG, Fufa DT. Generalized Joint Laxity in Orthopaedic Patients: Clinical Manifestations, Radiographic Correlates, and Management. J Bone Joint Surg Am. 2019 Mar 20;101(6):558-566. doi: 10.2106/JBJS.18.00458. No abstract available.
PubMed 30893238Lan R, Piatt ET, Bolia IK, Haratian A, Hasan L, Peterson AB, Howard M, Korber S, Weber AE, Petrigliano FA, Tan EW. Suture Tape Augmentation in Lateral Ankle Ligament Surgery: Current Concepts Review. Foot Ankle Orthop. 2021 Oct 20;6(4):24730114211045978. doi: 10.1177/24730114211045978. eCollection 2021 Oct.
PubMed 35097476Michels F, Cordier G, Burssens A, Vereecke E, Guillo S. Endoscopic reconstruction of CFL and the ATFL with a gracilis graft: a cadaveric study. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1007-14. doi: 10.1007/s00167-015-3779-1. Epub 2015 Sep 26.
PubMed 26410096Cho BK, Park JK, Choi SM, SooHoo NF. A randomized comparison between lateral ligaments augmentation using suture-tape and modified Brostrom repair in young female patients with chronic ankle instability. Foot Ankle Surg. 2019 Apr;25(2):137-142. doi: 10.1016/j.fas.2017.09.008. Epub 2017 Oct 18.
PubMed 29409289
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Modified Broström Repair + Suture Tape and Anatomic Reconstruction for CLAI in Chronic Lateral Ankle Instability in Generalized Joint Laxity Cases: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05698446
- Acronym / sponsor ID
- M2022514
- Conditions
- Ankle Sprains, Hypermobility Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 26 Jan 2023 (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. BPR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.
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 and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Modified Broström +Suture tape augmentation group | – | Procedure: Modified Broström + Suture tape augmentation operationPatients who accept a modified Broström +Suture tape augmentation operation |
| Anatomic reconstruction operation group | – | Procedure: Anatomic reconstruction operationPatients who accept an anatomic reconstruction |
| Open Modified Broström group | – | Procedure: Open Modified Broström procedurePatients who under went open Modified Broström-Gould surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 18- 60 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 (1 listed)
- Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years
Key exclusion criteria (1 listed)
- Patients with an acute or subacute ankle injury (within 3 months) 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
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 + 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 |
| Anatomic reconstruction operationAnatomic reconstruction operation | Procedure or surgery | Anatomic reconstruction operation group |
| Open Modified Broström procedureOpen Modified Broström-Gould surgery | Procedure or surgery | Open Modified Broström group |
Primary outcome
Karlsson-Peterson score
Time frame: postoperative Karlsson score at 1 year
This score is a primary scale for lateral ankle instability, with a maximum value of 100 and minimum value of 0. Larger Karlsson-Peterson score represents better ankle functional outcomes.
Karlsson-Peterson score
Time frame: postoperative Karlsson score at 2 years
This score is a primary scale for lateral ankle instability, with a maximum value of 100 and minimum value of 0. Larger Karlsson-Peterson score represents better ankle functional outcomes.
1 secondary outcome
Anterior displacement and talar tilt angle in stress radiography
Time frame: postoperative radiographic measures 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 11 Apr 2025.
- Background: 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.
- Background: PubMed 30893238Sacks HA, Prabhakar P, Wessel LE, Hettler J, Strickland SM, Potter HG, Fufa DT. Generalized Joint Laxity in Orthopaedic Patients: Clinical Manifestations, Radiographic Correlates, and Management. J Bone Joint Surg Am. 2019 Mar 20;101(6):558-566. doi: 10.2106/JBJS.18.00458. No abstract available.
- Background: PubMed 35097476Lan R, Piatt ET, Bolia IK, Haratian A, Hasan L, Peterson AB, Howard M, Korber S, Weber AE, Petrigliano FA, Tan EW. Suture Tape Augmentation in Lateral Ankle Ligament Surgery: Current Concepts Review. Foot Ankle Orthop. 2021 Oct 20;6(4):24730114211045978. doi: 10.1177/24730114211045978. eCollection 2021 Oct.
- Background: PubMed 26410096Michels F, Cordier G, Burssens A, Vereecke E, Guillo S. Endoscopic reconstruction of CFL and the ATFL with a gracilis graft: a cadaveric study. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1007-14. doi: 10.1007/s00167-015-3779-1. Epub 2015 Sep 26.
- Background: PubMed 29409289Cho BK, Park JK, Choi SM, SooHoo NF. A randomized comparison between lateral ligaments augmentation using suture-tape and modified Brostrom repair in young female patients with chronic ankle instability. Foot Ankle Surg. 2019 Apr;25(2):137-142. doi: 10.1016/j.fas.2017.09.008. Epub 2017 Oct 18.
- Individual participant dataSharing planned: Yes. The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers
Related trials for Ankle Sprains
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 Sprains and Hypermobility Syndrome, 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 1 inclusion and 1 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 11 Apr 2025. 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?
Karlsson-Peterson score (time frame: postoperative Karlsson score at 1 year). The study lists 2 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 NCT05698446, which also lists 5 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 11 Apr 2025.