Comparison of MBR + Suture Tape, MBR, and Anatomic Reconstruction for CLAI in GJL Cases: A Prospective Cohort Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Modified Broström + Suture tape augmentation operation

    Procedure/Surgery

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

  • Anatomic reconstruction operation

    Procedure/Surgery

    Anatomic reconstruction operation

  • Open Modified Broström procedure

    Procedure/Surgery

    Open Modified Broström-Gould surgery

Treatment groups

114 Participants
are divided into 3 treatment groups
Group A: Open Modified Broström +Suture tape augmentation group1 intervention
Group B: Anatomic reconstruction operation group1 intervention
Group C: Open Modified Broström group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
postoperative Karlsson score at 1 year
2

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.

Time frame
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

Time frame
postoperative radiographic measures at 2 years

Other outcomes

1

Rate of re-injury

After surgery, the rate of patients re-sprain

Time frame
the rate of re-injury at 2 years

Sponsors and contacts

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