Soporte de peso total versus parcial durante las primeras seis semanas de rehabilitación. Después de la reconstrucción del ligamento colateral del peroné
Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: A Randomized Controlled Trial
This is a prospective randomized controlled trial with the purpose to determine if patients undergoing fibular collateral ligament (FCL) reconstruction alone or combined FCL and anterior cruciate ligament (ACL) reconstructions can safely begin full controlled weightbearing for the first six weeks after surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:
- partial weightbearing
- full controlled weightbearing
An immobilizer brace in extension will be used from post-operative day 0 through 13 and a CTi ligament knee brace (Össur Americas, Foothill Ranch, California) will be used from 14 to 42 days post-surgery to protect against side-to-side motion while weight bearing.
Specific Aims
- Primary Aim: To determine if there is a difference in millimeters of varus gapping on anteroposterior (AP) stress radiographs at six months post-surgery between patients who are partial weight bearing versus full controlled weight bearing during the first six weeks of post-surgical rehabilitation. This distance will be compared to varus gapping measured on the contralateral uninjured control knee.
- Secondary Aim: To determine if there is a difference in pain, edema, and range of motion, gait, quadriceps strength, and patient reported outcomes between groups.
The Investigators hypothesize that there will be no clinically significant difference (< 2 mm change) in varus gapping between the control and treatment groups. Results of this study will help to expedite return to pre-injury levels of activity and decrease adverse sequelae associated with non-weight bearing such as osteopenia, muscle atrophy, loss of ankle range of motion, and increased risk of deep vein thrombosis.
The current standard of care for FCL reconstruction is early controlled partial weight -bearing for the first six weeks after surgery.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Becky Stone
- Número de teléfono: 952-456-7136
- Correo electrónico: research@tcomn.com
Copia de seguridad de contactos de estudio
- Nombre: Kayla Seiffert
- Número de teléfono: 952-456-7085
- Correo electrónico: research@tcomn.com
Ubicaciones de estudio
-
-
Minnesota
-
Edina, Minnesota, Estados Unidos, 55435
- Reclutamiento
- Twin Cities Orthopedics
-
Contacto:
- Becky Stone
- Número de teléfono: 952-456-7136
- Correo electrónico: research@tcomn.com
-
Investigador principal:
- Robert F LaPrade, MD, PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- ≥ 14 years old, <60
- Reconstruction of FCL alone
- Combined FCL + ACL reconstructions
- Males or females
- Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
Exclusion Criteria:
- < 14 years old, > 60
- Pregnant
- Revision FCL reconstructions
- Concurrent biceps femoris or lateral capsular repairs
- Concurrent PCL or MCL reconstructions
- Concomitant meniscus root or radial repair surgery with transtibial technique
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Partial weight -bearing for the first six weeks after surgery
Partial weightbearing will be defined as 40% of the patient's body weight. |
Patient is randomized to the weightbearing group the day after surgery. |
|
Experimental: Full weight -bearing for the first six weeks after surgery
If the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities. |
Patient is randomized to the weightbearing group the day after surgery. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Gapping (mm) measured on Standard of Care Varus stress radiographs
Periodo de tiempo: Pre-operative
|
stress radiograph |
Pre-operative
|
|
Gapping (mm) measured Standard of Care Varus stress radiographs
Periodo de tiempo: 6 months post-surgery
|
stress radiograph |
6 months post-surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Numeric Pain Scale (NPS) (0-10 rating)
Periodo de tiempo: Baseline and 6 months
|
Pain scale 0-100 |
Baseline and 6 months
|
|
Measurements by physical therapists (Edema, thigh circumference)
Periodo de tiempo: 4,7, and 10 months after surgery
|
Measurements with tape |
4,7, and 10 months after surgery
|
|
Measurements by physical therapists (Range of Motion)
Periodo de tiempo: 4,7, and 10 months after surgery
|
Measurements with goniometer |
4,7, and 10 months after surgery
|
|
Measurements by physical therapists (Quadriceps strength, gait analysis)
Periodo de tiempo: 4,7, and 10 months after surgery
|
Measurements by biomechanics lab |
4,7, and 10 months after surgery
|
|
Patient reported outcome scores
Periodo de tiempo: Baseline, 3 months, 6 months, 1 year
|
Surveys: International Knee Documentation Committee (IKDC), Cincinnati Knee Rating System (Cincinnati), Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner, Lysholm Knee Scoring Scale (Lysholm), and Veterans Rand 12 (VR-12) or Short Form-12 (SF-12) General Health Survey, lower extremity functional scale, Sports Medicine Questionnaire and survey/patient satisfaction |
Baseline, 3 months, 6 months, 1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert F LaPrade, MD, PhD, Twin Cities Orthopedics
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RFL_FWB vs PWB-FCL
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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