- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00710840
Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function
Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty
Aperçu de l'étude
Statut
Les conditions
Description détaillée
More than 400,000 TKAs are performed each year in the United States to alleviate pain and disability associated with knee OA. Although this procedure reliably reduces pain and improves function in people with knee OA, recovery of the strength of the quadriceps muscle to normal levels is rare. For years after a TKA, performance while walking or while doing a more physically demanding activity, such as stair climbing, is also significantly lower in people who have had a TKA than in healthy adults of the same age. Within the past few years, less invasive TKA surgical techniques have been developed as promising alternatives to traditional TKA. Minimally invasive TKA, or TKA(min), achieves the same surgical objectives, but possibly without doing as much damage to the quadriceps muscle as is seen with traditional TKA. No studies, however, have specifically investigated how TKA(min) might preserve quadriceps muscle function. This study will determine whether TKA(min) is better than TKA at improving quadriceps muscle force production and activation, increasing knee range of motion, and reducing post-operative pain to improve overall functional outcomes.
Participants who are scheduled to undergo knee replacement surgery will be randomly assigned to receive either traditional TKA or TKA(min). Prior to surgery, participants will attend a 30-minute orientation session and undergo certain tests to evaluate knee function. Functional testing will include timed walking, stair climbing, balance testing, and knee flexibility measurements. Other evaluations will include thigh muscle strength and activation testing, which uses brief electrical pulses to determine if the muscles are contracted as much as possible, and health status questionnaires. After the operation, participants will be instructed to use walking aids, such as a walker, crutches, or a cane, for a period of time. Participants will attend study visits for repeat testing 48 hours following surgery; at Months 1, 3, and 6; and at Years 1 and 2.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Colorado
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Boulder, Colorado, États-Unis, 80304
- University of Colorado Health Sciences Center
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Denver, Colorado, États-Unis, 80262
- University of Colorado Health Sciences Center
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Denver, Colorado, États-Unis, 80206
- National Jewish Medical and Research Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Diagnosis of osteoarthritis
- Eligible for a unilateral or bilateral primary TKA to be performed by Dr. Michael Dayton (University of Colorado Hospital)
- Minimum of 110 degrees of active knee flexion
- No greater than 10 degrees of anatomic knee varus, 15 degrees anatomic valgus, and 10 degrees flexion contracture
- Body mass index less ≤ 40 kg/m2
Exclusion Criteria:
- Any brain, circulation, or heart problems that limit function
- Severe osteoarthritis or other orthopedic conditions that limit function in the lower extremity that is not undergoing the TKA
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 1
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TKA Min is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
TKA Min, as opposed to TKA Traditional, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee.
This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
Autres noms:
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Comparateur actif: 2
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TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Quadriceps Muscle Force
Délai: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Knee Range of Motion
Délai: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Knee Flexion Active Range of Motion (AROM)
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Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Functional Performance: 6 Minute Walk (6MW) Distance
Délai: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Functional Performance: Stair Climb Test
Délai: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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This outcome measures the time (seconds) it takes to climb up and back down 12 steps.
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Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jennifer E. Stevens, MPT, PhD, University of Colorado, Denver
- Chercheur principal: Michael Dayton, MD, University of Colorado, Denver
- Chercheur principal: Wendy Kohrt, PhD, University of Colorado School of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
- 06-0183
- R03AR054538 (Subvention/contrat des NIH des États-Unis)
- 1R03AR054538-01A2 (Subvention/contrat des NIH des États-Unis)
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Essais cliniques sur Minimally Invasive Total Knee Arthroplasty [TKA Min]
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Northwest Surgical Specialists, VancouverStryker MAKO Surgical CorpRésilié