Non- vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction
Non-Weight Bearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Multiple Knee Ligament Reconstruction: A Randomized Controlled Trial
This is a prospective randomized controlled trial with the purpose to determine if patients undergoing isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL), posterolateral corner (PLC), and MCL reconstructions (or any combination of multiple ligaments) can safely begin partial controlled weightbearing for the first six weeks after surgery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:
- non-weightbearing
- partial weightbearing
An immobilizer brace in extension will be used from post-operative day 0 through 4 and a dynamic stabilizing posterior knee brace (Ossur) will be used from 5 days through 6 months post-surgery to protect against increased posterior translation forces due to gravity and while weightbearing for patients with PCL reconstructions.
Specific Aims
- Primary Aim: To determine if there is clinical equivalence in millimeters of posterior tibial translation on posterior stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
- Primary Aim: To determine if there is clinical equivalence in millimeters of valgus and/or varus compartment gapping on stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
- Secondary Aim: To determine if there is a difference in pain, edema, range of motion, gait, and quadriceps strength between groups.
The current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing for the first six weeks after surgery.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kayla Seiffert
- Numéro de téléphone: 952-456-7085
- E-mail: research@tcomn.com
Sauvegarde des contacts de l'étude
- Nom: Becky McGaver
- Numéro de téléphone: 952-456-7136
- E-mail: research@tcomn.com
Lieux d'étude
-
-
Minnesota
-
Edina, Minnesota, États-Unis, 55435
- Recrutement
- Twin Cities Orthopedics
-
Contact:
- Becky Stone
- Numéro de téléphone: 952-456-7136
- E-mail: research@tcomn.com
-
Chercheur principal:
- Robert F LaPrade, MD, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- ≥ 14 years old, <60
- Reconstruction of PCL alone
- Reconstruction of MCL alone
- Reconstruction of combined multiligament injuries (PCL+ (FCL, PLC, ACL, MCL))
- Reconstruction of multiligament injuries (ACL+MCL)
- 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 years old
- Pregnant
- Revision PCL reconstructions
- Previous or concurrent vascular injury (vascular bypass procedure)
- Associated fractures requiring concurrent surgery
- Concurrent meniscal root or radial repair surgery
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Non-weightbearing for the first six weeks after surgery
Not weightbearing after surgery |
Patient is randomized to the weightbearing group the day after surgery. |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gapping (mm) measured on Standard of Care Varus stress radiographs
Délai: Pre-operative
|
stress radiographs |
Pre-operative
|
|
Gapping (mm) measured on Standard of Care Varus stress radiographs
Délai: 6 months post-surgery
|
stress radiographs |
6 months post-surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Numeric Pain Scale (NPS) (0-10 rating)
Délai: Baseline and 6 months
|
Pain scale 0-100 |
Baseline and 6 months
|
|
Measurements by physical therapists (Edema, thigh circumference)
Délai: 4,7, and 10 months after surgery
|
Measurements with tape |
4,7, and 10 months after surgery
|
|
Measurements by physical therapists (Quadriceps strength, gait analysis)
Délai: 4,7, and 10 months after surgery
|
Measurements by biomechanics lab |
4,7, and 10 months after surgery
|
|
Patient reported outcome scores
Délai: 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
|
|
Measurements by physical therapists (range of motion)
Délai: 4,7, and 10 months after surgery
|
Measurements with goniometer |
4,7, and 10 months after surgery
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Robert F LaPrade, MD, PhD, Twin Cities Orthopedics
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RFL_NWB vs PWB-Multi-Knee Lig
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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