Clinical trial NCT06893250: Orthobiologic Treatment for Knee Osteoarthritis
Official title: Orthobiologic Treatment for Knee Osteoarthritis (Ortobiologisk Behandling av Kneleddsartrose)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis Knee
Keywords: osteoarthritis
knee
platelet rich plasma
adipose tissue
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients will be randomized into one of four treatment groups and then be followed up at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after intervention. They will fill out scores and be clinically evaluated, as well as radiologically examined at inclusion and at the final check up (x-ray and MRI).

Eligibility criteria: 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 \&lt;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

Primary outcomes:
measure: 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)
measure: 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)
measure: VAS (Visual analogue scale)
timeFrame: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)
Secondary outcomes:
measure: Radiological findings after treatment
timeFrame: At inclusion and 2 years after intervention.
Other outcomes:
Locations:
city: Tromso
country: Norway
facility: University Hospital in Northern Norway
state: Tromsø
Study officials:
References: