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Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®

2026년 8월 18일 업데이트: Soheil Ashkani Esfahani, Massachusetts General Hospital

The Effect of Augmented Brostrom Repair Using Bioinductive Implant in Patients With Lateral Ankle Instability

The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after open non-augmented Broström repair or open Broström repair augmented with the BioBrace Implant.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This is a single-center, prospective, randomized (1:1) interventional study investigating the use of the BioBrace® Implant in lateral ankle ligament repair procedures performed using the Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms:

Control Group: Open standard Broström repair of the lateral ankle

Treatment Group: Open Broström repair of the lateral ankle using a suture-anchor construct augmented with the BioBrace® Implant.

Both groups will be immobilized for 2 weeks and then will undergo standard accelerated rehabilitation protocols (early weight-bearing and sport-specific training) unless they are not tolerated which will lead to using traditional standard protocols.

Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 2 weeks, 2 months, 6 months, and 12 months using various patient-reported outcome measures to asses pain, function, satisfaction, activity and safety post surgery. Participants will also receive biweekly (every 2 weeks) electronic questionnaires assessing return to sport and return to daily/recreational activity. These biweekly assessments will continue until the participant reports full return to their preoperative level of activity or sport. Participants who do not reach preoperative activity/sport level will continue receiving biweekly questionnaires through the 1 year final visit.

연구 유형

중재적

등록 (추정된)

75

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • 모병
        • Brigham and Women's Hospital
        • 연락하다:
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Age 18-65 years
  • Chronic lateral ankle instability (>3 months) confirmed by clinical examination (positive anterior drawer test or talar tilt >10°) and imaging (stress X-ray or MRI).
  • No prior ankle surgery on the affected limb.
  • Willingness to follow postoperative visits and rehabilitation protocols and filling out the patient reported outcome measures (PROMs) forms.

Exclusion Criteria:

  • BMI>40
  • Significant secondary procedures done at the time of repair, including micro-fracture, or any other treatment of osteochondral lesions of the talus or tibia.
  • Concomitant deltoid ligament insufficiency.
  • Any worker's compensation case or any subject with a history of infection of the ankle predating the ankle repair. Current orthopedic issues, not related to the ankle, that prevented the patient from performing the functional tests.
  • Concomitant osteochondral lesions, significant degenerative changes, or severe varus/valgus deformity, neuromuscular disorders or non-adherence concerns.
  • Pregnant
  • Diagnosis of Ehlers-Danlos Syndrome or other connective tissue / hyperlaxity disorder.
  • Prior revision ankle ligament surgery on the affected limb (any revision Broström or lateral ligament reconstruction).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Standard Brostrom Repair (SBR)
Standard-of-care Brostrom repair
절차: Standard Brostrom Repair
Standard-of-care Brostrom repair for chronic lateral ankle instability
실험적: Augmented Brostrom Repair (ABR)
Brostrom repair augmented with BioBrace
장치: 보강술을 동반한 브로스트롬 수술
BioBrace를 이용한 브로스트롬 수술

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pain VAS
기간: From enrollment to the last follow-up at 12 months
The pain VAS (Visual Analog Scale) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients. It consists of a line marked from 0 to 10, with 0 representing "no pain" at one end and 10 "worst imaginable pain" at the other; patients mark their pain level on the line, which is then measured to provide a numerical score from 0 to 10.
From enrollment to the last follow-up at 12 months
PROMIS Scale v2.0 - Pain Intensity 3a
기간: From enrollment to the last follow-up at 12 months.
The PROMIS Scale v2.0 - Pain Intensity 3a scale utilizes a 3-question questionnaire to assess patients' pain experiences over the previous 7 days. The items include the intensity of pain at its worst, the intensity of pain on average, and the level of pain right now. The items are scored on a scale from "Had no pain" to "Very severe".
From enrollment to the last follow-up at 12 months.
NIH Toolbox Pain Interference CAT Ages 18 v3.0
기간: From enrollment to the last follow-up at 12 months.
The NIH Toolbox Pain Interference CAT Ages 18 v3.0 is a computerized adaptive test that evaluates how much pain has interfered with and affected a person's life and daily activities over the previous 7 days. The questions are generated dynamically based on previous answers. Results are reported as a T-score. A higher T-score indicates a greater degree of pain interference.
From enrollment to the last follow-up at 12 months.
PROMIS Scale v1.2 - Global Mental 2a
기간: From enrollment to the last follow-up at 12 months.
The PROMIS Scale v1.2 - Global Mental 2a is a two-question questionnaire assessing participants' mental health, mood, ability to think, and satisfaction with social activities and relationships. The questions are scored from "Excellent" to "Poor".
From enrollment to the last follow-up at 12 months.
PROMIS Scale v1.2 - Global Physical 2a
기간: From enrollment to the last follow-up at 12 months.
The PROMIS Scale v1.2 - Global Physical 2a is a two-question questionnaire designed to assess a participant's overall physical well-being. The participants are asked to rate their physical health on a scale from "Excellent" to "Poor" and their ability to carry out physical activities of daily living on a scale from "Completely" to "Not at all".
From enrollment to the last follow-up at 12 months.
Foot and Ankle Outcome Score (FAOS)
기간: From enrollment to the last follow-up at 12 months.
The Foot and Ankle Outcome Score (FAOS) is a 42-item questionnaire with 5 subscales: symptoms (5 items), stiffness (2 items), pain (9 items), daily living (17 items), sports and recreational activities (5 items), and quality of life (4 items). Each question is graded on a 5-point scale (none, mild, moderate, severe, and extreme problems).
From enrollment to the last follow-up at 12 months.
Foot and Ankle Ability Measure Scored
기간: From enrollment to last follow-up at 12 months.
The Foot and Ankle Ability Measure Scored tool has two sections. The first section asks participants to rate their difficulty completing activities of daily living on a scale from "No difficulty" to "Unable to do" over 21 different questions along with a rating their current level of function from 0 to 100, with 100 being their prior level of function. The second section asks participants to rate their difficulty in participating in sports activities on a scale from "No difficulty at all" to "Unable to do" over 7 different questions along with a rating their current level of function during sport activities from 0 to 100, with 100 being their prior level of function.
From enrollment to last follow-up at 12 months.
Clinical Assessment
기간: From enrollment to the last follow-up at 12 months.
Clinicians will assess participants during their follow-up appointments. The clinicians will measure an anterior drawer test, range of motion assessment, hindfoot alignment, wound/incision assessment, complications assessment, and a physical activity assessment.
From enrollment to the last follow-up at 12 months.

2차 결과 측정

결과 측정
측정값 설명
기간
Return to Activity
기간: From baseline until participants report full return to activity or until last follow-up at 12 months.
Participants will fill out biweekly (2 weeks) surveys assessing their participation in any physical activities or sport, participation in their primary physical activities or sport, how often and how long they participated, their performance in those activities, and their own subjective understanding of why their performance may be different than before their injuries.
From baseline until participants report full return to activity or until last follow-up at 12 months.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Massachusetts General Hospital

협력자

CONMED Corporation

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2028년 6월 1일

연구 완료 (추정된)

2028년 6월 1일

연구 등록 날짜

최초 제출

2026년 7월 13일

QC 기준을 충족하는 최초 제출

2026년 7월 13일

처음 게시됨 (실제)

2026년 7월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 18일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 2026P000101

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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