Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects (Mfxbracing)
Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
Redwood City, California, États-Unis, 94063
- Stanford University Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
- age 15-40
- neutral knee alignment
Exclusion Criteria:
- prior cartilage procedures performed in the same knee
- other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Unloader Bracing
This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.
|
The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
Autres noms:
|
|
Comparateur actif: Non-Bracing Arm
This group will be randomly selected and assigned to wear no brace post-operatively.
|
Microfracture performed with no post-operative unloader bracing
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
Délai: 2 years
|
KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures.
Scores between 0 and 100 represent the percentage of total possible score achieved.
|
2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Tegner Score (Clinical Outcome)
Délai: 2 years
|
The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports.
The patient is asked to select the level of participation that best describes their current level of activity and that before injury.
A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports.
A score >6 can only be achieved if the person participates in recreational or competitive sport.
|
2 years
|
|
Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
Délai: 2 years
|
SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.
A higher value indicates a better quality of life of the patient.
The scores range from 0 to 100.
|
2 years
|
|
Change From Baseline in Lysholm Score (Clinical Outcome)
Délai: 2 years
|
The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.
|
2 years
|
|
Change From Baseline in T2 Relaxation Time (Radiographic Outcome)
Délai: 2 years
|
T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.
|
2 years
|
|
Change From Baseline in Cartilage Volume (Radiographic Outcome)
Délai: 2 years
|
2 years
|
|
|
Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Délai: 2 years
|
2 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jason Dragoo, MD, Stanford University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- oss-mfx-2013
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .