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NCT05389371
OA Optimization Program Pilot Trial
Phase 1, PHASE2 trial testing Alberta Healthy Living Program in Osteo Arthritis Knee in 70 participants. Status unknown.
31 August 2024
Quick facts
| Lead sponsor | University of Calgary |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 70 |
| Start date | 28 June 2022 |
| Primary completion | 31 August 2024 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Alberta Healthy Living Program
- Alberta Obesity Centre Program
- Osteoarthritis advice
- Physiotherapy — full drug profile →
Conditions studied
- Osteo Arthritis Knee — all drugs for Osteo Arthritis Knee →
- Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →
- Osteoarthritis, Hip — all drugs for Osteoarthritis, Hip →
- Osteoarthritis — all drugs for Osteoarthritis →
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.
Verify or expand the search:
- PubMed search for NCT05389371
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteo Arthritis Knee
Currently open trials in the same condition.
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- NCT06485843 — An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Jo · Phase 2 · recruiting
- NCT06965946 — Intermittent Hypoxia-Hyperoxia Combined With Physical Therapy for Knee Osteoarthritis · NA · recruiting
- NCT06058169 — Effects of Home Base Whole-body Vibration in Osteoarthritis. (VIBE-Rx2) · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05389371 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Calgary
- Last refreshed: 22 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05389371.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing