Ankle SprainsNCT05196906
The Clinical Outcomes of the Modified Broström vs Anatomic Reconstruction Operation in CLAI and GJL
An observational study of Ankle Sprains and Instability, Joint, run by Peking University Third Hospital at 1 site in China.
Trial summary
Investigators designed this prospective cohort study to compare the clinical outcomes of modified Broström operation and anatomical reconstruction for the treatment of CLAI and GJL. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankle Sprains, Instability, Joint, Joint Hypermobility
- What is being tested?
- Modified Broström operation and anatomic reconstruction operation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 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 16- 50 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: The Clinical Outcomes Comparing the Modified Broström vs Anatomic Reconstruction Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity
Investigators designed this prospective cohort study to compare the clinical outcomes of modified Broström operation and anatomical reconstruction for the treatment of CLAI and GJL.
Read the detailed description
The modified Broström operation is still the first line to treat chronic lateral ligament instability (CLAI). However, some studies indicate the modified Broström operation may bring a higher rate of re-injury in generalized joint laxity (GJL). Anatomical reconstruction was reported to generate similar results and less rate of re-injury compared in patients with CLAI. However, the clinical outcomes of the two operations are not discussed in CLAI and GJL. So, investigators designed this prospective cohort study. The primary outcomes are Karlsson, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.
- Conditions
- Ankle Sprains, Instability, Joint, Joint Hypermobility
- Being tested
- Modified Broström operation and anatomic reconstruction operation
- Keywords
- chronic lateral ankle instability, generalized joint laxity, re-injury, modified Brostrom operation, anatomic reconstruction
- Medical subject headings
- Ankle Injuries, Joint Instability, Reinjuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Broström operation and anatomic reconstruction operationProcedure or surgery
Patients with CLAI and GJL will accept the Modified Broström operation or anatomic reconstruction operation.
| Study group | Role | What they receive |
|---|---|---|
| Modified Broström operation group | Patients who accept a modified Broström operation Receives: Procedure: Modified Broström operation and anatomic reconstruction operation | |
| Anatomic reconstruction operation group | Patients who accept an anatomic reconstruction Receives: Procedure: Modified Broström operation and anatomic reconstruction operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Karlsson score
This score is a primary scale for lateral ankle instability
Measured: postoperative Karlsson score at 1 year.
Karlsson score
This score is a primary scale for lateral ankle instability
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 posted19 Jan 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 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
- 100 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
- Investigators
- Dong Jiang, MD, Principal investigator, Peking University Third Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196906
- Sponsor's protocol ID
- M2021565
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2021
- Last updated
- 11 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers
Publications
de Vries JS, Krips R, Sierevelt IN, Blankevoort L, van Dijk CN. Interventions for treating chronic ankle instability. Cochrane Database Syst Rev. 2011 Aug 10;2011(8):CD004124. doi: 10.1002/14651858.CD004124.pub3.
PubMed 21833947Michels F, Cordier G, Guillo S, Stockmans F; ESKKA-AFAS Ankle Instability Group. Endoscopic Ankle Lateral Ligament Graft Anatomic Reconstruction. Foot Ankle Clin. 2016 Sep;21(3):665-80. doi: 10.1016/j.fcl.2016.04.010.
PubMed 27524711Sacks 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 30893238Xu 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 27496909Park KH, Lee JW, Suh JW, Shin MH, Choi WJ. Generalized Ligamentous Laxity Is an Independent Predictor of Poor Outcomes After the Modified Brostrom Procedure for Chronic Lateral Ankle Instability. Am J Sports Med. 2016 Nov;44(11):2975-2983. doi: 10.1177/0363546516656183. Epub 2016 Aug 1.
PubMed 27480980
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
- The Clinical Outcomes Comparing the Modified Broström vs Anatomic Reconstruction Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity
- ClinicalTrials.gov ID
- NCT05196906
- Acronym / sponsor ID
- M2021565
- Conditions
- Ankle Sprains, Instability, Joint, Joint Hypermobility
- Keywords
- chronic lateral ankle instability, generalized joint laxity, re-injury, modified Brostrom operation, anatomic reconstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jan 2022 (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.
Investigators designed this prospective cohort study to compare the clinical outcomes of modified Broström operation and anatomical reconstruction for the treatment of CLAI and GJL.
Detailed description
The modified Broström operation is still the first line to treat chronic lateral ligament instability (CLAI). However, some studies indicate the modified Broström operation may bring a higher rate of re-injury in generalized joint laxity (GJL). Anatomical reconstruction was reported to generate similar results and less rate of re-injury compared in patients with CLAI. However, the clinical outcomes of the two operations are not discussed in CLAI and GJL. So, investigators designed this prospective cohort study. The primary outcomes are Karlsson, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Broström operation group | – | Procedure: Modified Broström operation and anatomic reconstruction operationPatients who accept a modified Broström operation |
| Anatomic reconstruction operation group | – | Procedure: Modified Broström operation and anatomic reconstruction operationPatients who accept an anatomic reconstruction |
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 16- 50 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 operation and anatomic reconstruction operationPatients with CLAI and GJL will accept the Modified Broström operation or anatomic reconstruction operation. | Procedure or surgery | Anatomic reconstruction operation group, Modified Broström operation group |
Primary outcome
Karlsson score
Time frame: postoperative Karlsson score at 1 year.
This score is a primary scale for lateral ankle instability
Karlsson score
Time frame: postoperative Karlsson score at 2 years.
This score is a primary scale for lateral ankle instability
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.
- Results publication: PubMed 21833947de Vries JS, Krips R, Sierevelt IN, Blankevoort L, van Dijk CN. Interventions for treating chronic ankle instability. Cochrane Database Syst Rev. 2011 Aug 10;2011(8):CD004124. doi: 10.1002/14651858.CD004124.pub3.
- Results publication: PubMed 27524711Michels F, Cordier G, Guillo S, Stockmans F; ESKKA-AFAS Ankle Instability Group. Endoscopic Ankle Lateral Ligament Graft Anatomic Reconstruction. Foot Ankle Clin. 2016 Sep;21(3):665-80. doi: 10.1016/j.fcl.2016.04.010.
- Results publication: 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.
- 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.
- Results publication: PubMed 27480980Park KH, Lee JW, Suh JW, Shin MH, Choi WJ. Generalized Ligamentous Laxity Is an Independent Predictor of Poor Outcomes After the Modified Brostrom Procedure for Chronic Lateral Ankle Instability. Am J Sports Med. 2016 Nov;44(11):2975-2983. doi: 10.1177/0363546516656183. Epub 2016 Aug 1.
- Individual participant dataSharing planned: No. The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers
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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.
Dong Jiang, MD principal investigator
Peking University Third Hosptial
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 Instability, 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 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 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 NCT05196906, 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.