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Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®

18 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

75

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Reclutamiento
        • Brigham and Women's Hospital
        • Contacto:
          • Christopher Miller, MD
          • Número de teléfono: 617-525-9382
          • Correo electrónico: cpmiller@mgb.org
      • Boston, Massachusetts, Estados Unidos, 02114
        • Reclutamiento
        • Massachusetts General Hospital
        • Contacto:
          • Gregory Waryasz, MD
          • Número de teléfono: 781-487-4338
          • Correo electrónico: gwaryasz@mgb.org

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Standard Brostrom Repair (SBR)
Standard-of-care Brostrom repair
Procedimiento: Standard Brostrom Repair
Standard-of-care Brostrom repair for chronic lateral ankle instability
Experimental: Augmented Brostrom Repair (ABR)
Brostrom repair augmented with BioBrace
Dispositivo: Reparación de Broström con refuerzo
Reparación de Brostrom con BioBrace

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain VAS
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Return to Activity
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Massachusetts General Hospital

Colaboradores

CONMED Corporation

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de junio de 2028

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

13 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de julio de 2026

Publicado por primera vez (Actual)

16 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 2026P000101

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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