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NCT05389371

OA Optimization Program Pilot Trial

Status unknown Phase 1, PHASE2 Last updated 22 May 2024
What this trial tests

Phase 1, PHASE2 trial testing Alberta Healthy Living Program in Osteo Arthritis Knee in 70 participants. Status unknown.

Timeline
28 June 2022
Primary endpoint
31 August 2024
30 September 2025

Quick facts

Lead sponsorUniversity of Calgary
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment70
Start date28 June 2022
Primary completion31 August 2024
Estimated completion30 September 2025
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Calgary

Who can join

18 and older, any sex, with Osteo Arthritis Knee or Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Total joint replacement is a highly successful treatment option for people affected by severe osteoarthritis (OA), however, the mismatch between resources and demand for this surgery means that many patients face long wait times while enduring worsening pain and disability. The Alberta Hip and Knee Program is a centralized intake system for patients referred for total joint replacement assessment. Over 3000 patients are assessed annually at the Calgary location (Alberta Hip and Knee Clinic at Gulf Canada Square) where previously patients waited an average of 43 weeks for a surgical consult then an additional 30 weeks until surgery. Given that many elective surgeries in Alberta have been cancelled in response to the COVID19 pandemic, these wait times have increased significantly, with no clearing of the surgical backlog for the foreseeable future. Long wait times for patients can become a spiral of more debility, less mobility, and subsequent weight gain. The current standard of care for patients with obesity awaiting surgery provides little support or guidance beyond general advice about the importance of a healthy weight and remaining active. This waiting period represents an untapped window of opportunity to intervene and help patients with obesity and OA to lessen their disease burden and improve overall health, while addressing patient priorities such as regaining lost function and improving quality of life. Many patients with osteoarthritis also have obesity. The best practices in obesity treatment requires a multidisciplinary approach. Our aim is to conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility of incorporating the multidisciplinary Alberta Obesity Centre program into the clinical care pathway for patients with obesity and OA while they await surgical evaluation at the Alberta Hip and Knee Clinic at Gulf Canada Square. The results of this feasibility trial will help inform a larger scale trial that will be powered for clinical and health economics outcomes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Osteo Arthritis Knee

Currently open trials in the same condition.

Other University of Calgary trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing