Rotator Cuff Injury to Surgery (RC-IS)
Effect of Surgical Wait Times on Outcomes of Rotator Cuff Surgery
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Consented patients will undergo a pre-operative assessment conducted by a study physiotherapist, including the following: 1) demographic information (age, gender, height, weight, smoking status, employment, recreational activities, time of injury, etc.); 2) shoulder ROM, 3) shoulder strength using a handheld dynamometer, and 4) subjective shoulder-specific outcome measures which include the Western Ontario Rotator Cuff Score (WORC), American Shoulder and Elbow Score (ASES), and Simple Shoulder Test (SST). Measurement of tear size will also be documented by an experienced radiologist from the initial MRI or ultrasound.
Patients will undergo initial consultation with the orthopaedic surgeon to confirm suitability for surgical management. If deemed appropriate to continue as a participant, the individual participants will be randomized to one of the two study groups. If in the Expedited group, the patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sports medicine physician. If randomized to the Control or 'Typical Wait Time' Group, surgery will take place no earlier than 9 months and no later than 12 months after the sports medicine physician consult.
Just prior to surgery, a second diagnostic imaging test will take place, either ultrasound or MRI, to document progress in tear size and any secondary pathology in the control group. Diagnostic test findings will be confirmed intraoperatively. All rotator cuff repairs will be performed by one of four fellowship trained orthopaedic surgeons.
The control study group will be sent the subjective questionnaires at 8 week intervals while they are waiting for surgery. Post-surgery study follow-ups will take place at 6, 12, and 24 months for both groups. All patients will be provided with the same rehabilitation protocol including pain management, range of motion and strengthening exercises. The same data as that collected pre-surgery will be repeated as well as any occurrences of failure of the repair. Failure of the repair is defined as ongoing severe pain, limited ROM, and/or decreased strength. If a failure occurs, follow-ups will continue until 24 months following failure or 24 months following revision surgery, if performed.
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Manitoba
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Winnipeg, Manitoba, Canada, R3M3E4
- Pan Am Clinic
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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:
- Between the ages of 45 and 70 years old
- Acute full-thickness rotator cuff tear of supraspinatus an/or infraspinatus (as confirmed by appropriate diagnostic imagine)
Exclusion Criteria:
- Presence of a tear of the subscapularis and/or teres minor;
- Presence of a partial-thickness tear of the supraspinatus/infraspinatus;
- Patient has undergone previous RC surgery to the affected shoulder;
- Patient has an active WCB Claim or prior claim related to their shoulder;
- Previous major joint trauma, infection, or avascular necrosis;
- Chronic dislocation, inflammation, or degenerative glenohumeral arthropathy;
- Evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
- Psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
- Major medical illness where life expectancy is less than 2 years;
- Does not speak/read/understand English;
- No fixed address or means of contact;
- Unwillingness to complete necessary follow-ups
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: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Early Surgery
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Patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sport medicine physician.
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|
Expérimental: Regular Wait Time
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Surgery will take place no earlier than 9 months and no later than 12 months after the sport medicine physician consult.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Western Ontario Rotator Cuff
Délai: 24 months
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WORC score questionnaire is a tool designed for self-assessment of shoulder function for patients with rotator cuff problems.
Difference between study arm outcomes will be assessed using pre-op WOSI score as a covariate
|
24 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
American Shoulder and Elbow Surgeons (ASES)
Délai: 24 months
|
The ASES assessment (patient report section) is a region-specific questionnaire designed for self-assessment of aspects of pain and function.
Difference between study arm outcomes will be assessed using pre-op ASES score as a covariate
|
24 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Injury to Surgery Time
Délai: 24 months
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Time will be calculated from initial injury to consultation to surgery.
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24 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jeff Leiter, MSc, PhD, Pan Am Clinic
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
- B2012:112
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