Orthobiologic Treatment for Knee Osteoarthritis (NCT06893250) | Clinical Trial Compass
By InvitationPhase 2/3
Orthobiologic Treatment for Knee Osteoarthritis
Norway160 participantsStarted 2024-09-23
Plain-language summary
The goal of this randomized clinical trial is to compare treatment for osteoarthritis in the knee using platelet rich plasma (PRP) or adipose stem cells (ADS). The main questions it aims to answer are:
* Will the patients clinically benefit from the treatment, and if so, which treatment is better?
* Will there be radiological findings to support this? Participants will be randomized into one of four groups: PRP, ADS, PRP + ADS or placebo treatment (saline) and will be examined and get an X-ray and MRI of the knee taken at inclusion and after 1 and 2 years.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic osteoarthritis in the knee grade I-III using the Kellgren-Lawrance Grading Scale
* Age 40-70 years
* Minimum VAS 3
* No use of NSAIDs or steroids the last 14 days
* No injections of hyaluronic acid the last three months
* Varus/valgus deformity \<5 degrees as evaluated on x-ray imaging
Exclusion Criteria:
* Pregnant or breastfeeding women
* Cancer
* Other etiologies of knee pain (refered pain, pain from the back, dislocated meniscus on MRI, osteoarthritis grade IV using the Kellgren-Lawrance Grading Scale)
* Previous knee surgery on the affected knee
* Secondary osteoarthritis in the knee
* Previous infection in the knee
* Other diseases (rheumatoid arthritis, diabetes, systemic diseases or corticosteroid-demaning disease)
* Patients with a high risk of deep vein thrombosis
* Patients who cannot cooperate/are low compliance (psychiatric disease) or has contraindications for MRI
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
KOOS (The Knee injury and Osteoarthritis Outcome Score)
Timeframe: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)
2
WOMAC score (Western Ontario og McMaster Universities Osteoarthritis Index)
Timeframe: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)
3
VAS (Visual analogue scale)
Timeframe: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)