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RecruitingNCT06897293Updated May 20, 2026

Comparison of MBR + Suture Tape and MBR for CLAI : A Prospective Cohort Study

An observational study in Ankle Sprain and Hypermobility, Joint, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Peking University Third Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
86
Ages
15 Years to 55 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ankle Sprain
  • Hypermobility, Joint
03

In context

Ankle Injuries

350 studies on the registry are indexed under Ankle Injuries; 74 are open to participants now.

This study's planned enrollment of 86 is close to the median of 84 across 73 observational studies indexed under Ankle Injuries.

Browse Ankle Injuries studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of lateral ankle instability
  • Beighton score ≥4
  • Age with 18 to 60 years

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
86 participants (estimated)
Patient registry
No

Groups and cohorts

  • Open Modified Broström +Suture tape augmentation group

    Patients who accept a modified Broström procedure + Suture tape augmentation operation

    Procedure: Modified Broström procedure + Suture tape augmentation operation

  • Open Modified Broström group

    Patients who accept a modified Broström procedure operation

    Procedure: Modified Broström procedure operation

Interventions

  • ProcedureModified Broström procedure + Suture tape augmentation operation

    Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation

  • ProcedureModified Broström procedure operation

    Patients with CLAI and GJL will accept the Modified Broström procedure operation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: postoperative AOFAS score at 1 year

  2. 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.

    Time frame: postoperative AOFAS score at 2 years

  3. 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.

    Time frame: postoperative AOFAS score at 6 months

  4. 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.

    Time frame: postoperative AOFAS score at 3 months

Secondary outcomes

  1. 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

    Time frame: postoperative radiographic measures at 2 years

  2. Rate of re-injury

    The rate of patients re-sprain after the surgery

    Time frame: the rate of re-injury at 2 years

Other outcomes

  1. Signal to noise value of anterior talofibular ligament

    Signal to noise value of the anterior talofibular ligament

    Time frame: 6 months post-treatment

  2. Signal to noise value of the anterior talofibular ligament

    Signal to noise value of the anterior talofibular ligament

    Time frame: 12 months post-treatment

  3. Signal to noise value of the anterior talofubular ligament

    Signal to noise value of the anterior talofibular ligament

    Time frame: 24 months post-treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 34252562 ↗
  • 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 27496909 ↗

Individual participant data

Plan to share: Yes — The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2021 (actual). Primary completion is estimated for Jun 2026, 60 months after the start.

Of 34 non-industry observational studies under Ankle Injuries, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 45. This study's planned 60 months is above that.

Counting every sponsor, half of 38 studies reached it within 11 months; a quarter within 5 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2025
First posted
Mar 26, 2025
StartActual
Jun 1, 2021
Primary completionEst.
Jun 1, 2026
CompletionEst.
Jun 1, 2026
Last update
May 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06897293
Responsible party
Jiang Dong (Chief physician, Peking University Third Hospital) — Principal investigator
First posted
Mar 26, 2025
Start date
Jun 1, 2021
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
May 20, 2026

Study contacts

Dong Jiang, MD
Contact
bysyjiangdong@126.com
13811280948
Haoxuan Liu, MD
Contact
2210301304@stu.pku.edu.cn
13716163357

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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