Ankle SprainsNCT05284188
The Clinical Outcomes of the Arthroscopic and Open Modified Broström Operation in CLAI and GJL
A study testing Open or arthroscopic Modified Broström operation in people with Ankle Sprains and Instability, Joint, run by Peking University Third Hospital at 1 site in China.
Trial summary
Investigators designed this randomized controlled trial to compare the clinical outcomes of open and arthroscopic modified Broström operation 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?
- Open or arthroscopic Modified Broström operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2018to 1 Dec 2021
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
About this study
Official title: The Clinical Outcomes Comparing Open and Arthroscopic Modified Broström Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity
Investigators designed this randomized controlled trial to compare the clinical outcomes of open and arthroscopic modified Broström operation for the treatment of CLAI and GJL.
Read the detailed description
The open modified Broström operation is the first line to treat chronic lateral ligament instability (CLAI). Arthroscopic techniques gain popularity for less invasivity, quick recovery to normal and sports activities, and the possibility to treat other intraarticular disorders. Studies have shown significantly poor clinical and radiological outcomes and a higher rate of failure in patients with generalized joint laxity (GJL) than patients without after open modified Broström operation. However, there is no study to compare the open and arthroscopic modified Brostrom operation for patients with GJL and CLAI. So, investigators designed this randomized controlled trial. The primary outcomes are Karlsson, American Orthopaedic Foot \& Ankle Society, and visual analogue scales. 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
- Open or arthroscopic Modified Broström operation
- Keywords
- chronic lateral ankle instability, generalized joint laxity, modified Brostrom operation, arthroscopic, open
- 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.
Open or arthroscopic Modified Broström operationProcedure or surgery
Patients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström operation.
| Study group | Role | What they receive |
|---|---|---|
| Open Modified Broström operation group | Active comparator | Patients who accept an open modified Broström operation Receives: Procedure: Open or arthroscopic Modified Broström operation |
| Arthroscopic Modified Broström operation group | Active comparator | Patients who accept an arthroscopic modified Broström operation Receives: Procedure: Open or arthroscopic Modified Broström 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 posted17 Mar 2022
- Study start8 Jan 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
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
- NCT05284188
- Sponsor's protocol ID
- M2021052
- Status last verified
- Jan 2018
- First submitted
- 9 Mar 2022
- Last updated
- 27 Jun 2022
- 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 21833947Sacks 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 27480980Li H, Hua Y, Li H, Ma K, Li S, Chen S. Activity Level and Function 2 Years After Anterior Talofibular Ligament Repair: A Comparison Between Arthroscopic Repair and Open Repair Procedures. Am J Sports Med. 2017 Jul;45(9):2044-2051. doi: 10.1177/0363546517698675. Epub 2017 Apr 10.
PubMed 28394631Wang AH, Su T, Jiang YF, Zhu YC, Jiao C, Hu YL, Guo QW, Jiang D. Arthroscopic modified Brostrom procedure achieved similar favorable short term outcomes to open procedure for chronic lateral ankle instability cases with generalized joint laxity. Knee Surg Sports Traumatol Arthrosc. 2023 Sep;31(9):4043-4051. doi: 10.1007/s00167-023-07431-x. Epub 2023 May 10.
PubMed 37162539
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcomes Comparing Open and Arthroscopic Modified Broström Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity
- ClinicalTrials.gov ID
- NCT05284188
- Acronym / sponsor ID
- M2021052
- Conditions
- Ankle Sprains, Instability, Joint, Joint Hypermobility
- Keywords
- chronic lateral ankle instability, generalized joint laxity, modified Brostrom operation, arthroscopic, open
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 17 Mar 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 randomized controlled trial to compare the clinical outcomes of open and arthroscopic modified Broström operation for the treatment of CLAI and GJL.
Detailed description
The open modified Broström operation is the first line to treat chronic lateral ligament instability (CLAI). Arthroscopic techniques gain popularity for less invasivity, quick recovery to normal and sports activities, and the possibility to treat other intraarticular disorders. Studies have shown significantly poor clinical and radiological outcomes and a higher rate of failure in patients with generalized joint laxity (GJL) than patients without after open modified Broström operation. However, there is no study to compare the open and arthroscopic modified Brostrom operation for patients with GJL and CLAI. So, investigators designed this randomized controlled trial. The primary outcomes are Karlsson, American Orthopaedic Foot \& Ankle Society, and visual analogue scales. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Modified Broström operation group | Active comparator | Procedure: Open or arthroscopic Modified Broström operationPatients who accept an open modified Broström operation |
| Arthroscopic Modified Broström operation group | Active comparator | Procedure: Open or arthroscopic Modified Broström operationPatients who accept an arthroscopic modified Broström operation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Open or arthroscopic Modified Broström operationPatients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström operation. | Procedure or surgery | Arthroscopic Modified Broström operation group, Open 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
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 27 Jun 2022.
- Background: 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.
- 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 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 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.
- Background: PubMed 28394631Li H, Hua Y, Li H, Ma K, Li S, Chen S. Activity Level and Function 2 Years After Anterior Talofibular Ligament Repair: A Comparison Between Arthroscopic Repair and Open Repair Procedures. Am J Sports Med. 2017 Jul;45(9):2044-2051. doi: 10.1177/0363546517698675. Epub 2017 Apr 10.
- Derived from this study: PubMed 37162539Wang AH, Su T, Jiang YF, Zhu YC, Jiao C, Hu YL, Guo QW, Jiang D. Arthroscopic modified Brostrom procedure achieved similar favorable short term outcomes to open procedure for chronic lateral ankle instability cases with generalized joint laxity. Knee Surg Sports Traumatol Arthrosc. 2023 Sep;31(9):4043-4051. doi: 10.1007/s00167-023-07431-x. Epub 2023 May 10.
- 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. This study is not recruiting at the moment.
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?
A study testing Open or arthroscopic Modified Broström operation in people with 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: finished, as of the sponsor's last update on 27 Jun 2022. 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?
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?
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 NCT05284188, which also lists 6 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 27 Jun 2022.