ACTRN12620000870954
Active, Not Recruiting
Phase 3
Evaluating the efficacy and cost-effectiveness of stem cell injections in people with mild to moderate knee osteoarthritis: a randomised placebo-controlled trial (The SCUlpTOR trial)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Knee osteoarthritis
- Sponsor
- niversity of Sydney
- Enrollment
- 321
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability and willingness to participate and complete the study
- •Having internet access and an active email account
- •Having functional English
- •Australian Citizen or Permanent resident
- •People \>\=40 years of age
- •Knee OA as defined by the clinical and radiographic American College of Rheumatology (ACR) criteria
- •Presence of pain in the study knee for at least half of the days in the previous month
- •Average pain intensity \>\= 40 and \<\= 90 on a 0\-100 visual analogue scale (VAS) over the past week before the Online Screening and Baseline surveys
- •Kellgren\-Lawrence grade (KLG) 2 or 3 of the study knee based on knee radiographs
- •Medial or lateral minimal joint space width (mJSW) between 0\.5 and 4 mm of the study knee based on radiographs
Exclusion Criteria
- •Incomplete online screening surveys
- •Participants that are non\-responders after completing the screening survey but before being enrolled
- •Women who are pregnant or breastfeeding, or women of childbearing potential not willing to use contraceptive methods for the duration of the study
- •Bilateral symptomatic knee OA if the patient\-reported pain intensity in the contralateral knee is \>\= 30 on a 0\-100 VAS
- •Significant injury in the study knee that led to substantial loss of function or surgeries within the past 6 months
- •Prior knee joint replacement or high tibial osteotomy in the study knee
- •Surgery on the study knee within the past 12 months
- •Planned surgery for the study knee in the next 24 months
- •History of crystalline arthropathy, autoimmune arthritis, hemochromatosis or fibromyalgia. Except for the following conditions:
- •i. participants diagnosed with gout are eligible for the study as long as the condition is being appropriately treated and they have not experienced flare\-ups for at least 12 months
Outcomes
Primary Outcomes
Not specified
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