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Functional Recovery After Total Knee Arthroplasty

19 février 2018 mis à jour par: Mahidol University

The Evaluation of Short-term Functional Recovery of Total Knee Arthroplasty Patients

Total knee replacement is one of the most successful surgical procedures in Orthopaedics. However, 10-20% of the patients are still dissatisfied with the results of the surgery. In general, the evaluation of postoperative functional outcomes are usually measured by self-report questionnaires, such as the Western Ontario and Mcmaster Universities osteoarthritic Index (WOMAC) and the Short Form-36 health survey (SF-36). Another method to evaluate functional outcome of the patients is to use the performance-based tests such as the two-minute walk test, but there is still little information regarding its use for evaluating functional recovery in patients receiving total knee arthroplasty.

The objectives this study are: 1) to assess the relationship between self-report questionnaires and performance-based tests among patients scheduling for TKA; and 2) to identify clinical variables that are associated with pre- and postoperative functional performance of the patients.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Osteoarthritis (OA) of the knee is one of the most prevalent age-related musculoskeletal conditions, resulting in significant impairment in patients' abilities to perform activities and adversely impacting their quality of life. The level of impairment in patients with knee OA can be measured using validated self-report questionnaires, such as the disease-specific Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the generic Medical Outcomes Study Short Form-36 (SF-36). Self-report questionnaires have been recommended by some investigators for their high internal consistency and ease of administration. Another method to evaluate physical function in patients with knee OA is to use performance-based tests. These tests are tools that assess patients' ability to execute a task in a standardized environment, and include the 2-minute walk test (2MWT) and the timed get-up-and-go test (TUG).

Among all the self-reported questionnaires for knee OA, the WOMAC is one of the most commonly used for baseline assessment and for measurement of treatment outcome, and has been validated for patients undergoing total knee arthroplasty (TKA). Although the WOMAC provides information on how individuals perceive their physical function in their own environment, it does not describe their ability to perform a specific task or action. In addition, some investigators showed that scores from self-report questionnaires before and after arthroplasty can overestimate patients' actual functional capacity. For example, Parent et al demonstrated that total knee arthroplasty patients had a dramatic improvement at 2 months as assessed by the WOMAC function subscale, however there were no significant changes when measured with performance-based tests assessing gait speed and stair ascent duration. Therefore, clinicians should be cautious when interpreting findings from studies that provide only self-report questionnaire scores. Given that self-report questionnaires may over-estimate functional status after joint replacement, some authors advocate performance-based tests as measures of outcome, and recommend their use during the preoperative period as baseline measurements followed by subsequent comparison with postoperative measurements.

The objectives of this study are: 1) to assess the relationship between self-reported questionnaires (WOMAC and SF-36) and performance-based tests (2MWT, TUG) among patients scheduling for TKA; and 2) to identify clinical variables that are associated with pre- and post-operative performance of the 2MWT and TUG. Our hypothesis is that correlations between self-report questionnaires and performance-based tests would be low to moderate, and thus these two types of measurements evaluate distinct domains of functional status in patients undergoing TKA.

Type d'étude

Observationnel

Inscription (Réel)

80

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Bangkok
      • Bangkoknoi, Bangkok, Thaïlande, 10700
        • Siriraj Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients who receive uncomplicated total knee replacement by a single surgeon

La description

Inclusion Criteria:

  • Patients who aged between 40-100 years
  • Patients who diagnosed with end-stage osteoarthritis of the knee

Exclusion Criteria:

  • Patients who receive total knee replacement on the contralateral side during the past 6 months
  • Patients with diseases or conditions that may affect postoperative functional recovery such as severe cardiopulmonary disease
  • Unable to participate in postoperative follow-up visits
  • Prior surgery on the affected knee, such as high tibial osteotomy
  • Patients with complex deformity who require bone grafting or metal augments

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Total knee arthroplasty
Patients undergoing uncomplicated total knee replacement
All patients will undergo total knee replacement using midvastus approach by single surgeon.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Change of the 2-minute walk test (2MWT) from baseline to at 1 year after surgery
Délai: baseline, 6 weeks, 3 months, 6 months and 1 year after surgery
baseline, 6 weeks, 3 months, 6 months and 1 year after surgery

Mesures de résultats secondaires

Mesure des résultats
Délai
Change of the Timed get-up-and-go test (TUG) from baseline to 1 year after surgery
Délai: baseline, 6 weeks, 3 months, 6 months and 1 year after surgery
baseline, 6 weeks, 3 months, 6 months and 1 year after surgery
Change of the pain scores on the Visual Analog Scale from baseline to 1 year after surgery
Délai: baseline, 6 weeks, 3 months, 6 months and 1 year after surgery
baseline, 6 weeks, 3 months, 6 months and 1 year after surgery
Change of the functional scores on the WOMAC index (Thai version) from baseline to 1 year after surgery
Délai: baseline, 3 months, 6 months and 1 year after surgery
baseline, 3 months, 6 months and 1 year after surgery
Change of the physical function domain of the SF-36 Health Survey from baseline to 1 year after surgery
Délai: baseline, 3 months, 6 months and 1 year after surgery
baseline, 3 months, 6 months and 1 year after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Aasis Unnanuntana, M.D., Siriraj Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2013

Achèvement primaire (Réel)

1 février 2018

Achèvement de l'étude (Réel)

1 février 2018

Dates d'inscription aux études

Première soumission

2 juin 2014

Première soumission répondant aux critères de contrôle qualité

3 juin 2014

Première publication (Estimation)

5 juin 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 février 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 février 2018

Dernière vérification

1 février 2018

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 126/2556(EC2)

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 .

Essais cliniques sur Total knee arthroplasty

3
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