Osteoarthritis Knee
Conditions
Keywords
osteoarthritis, knee, platelet rich plasma, adipose tissue
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).
Interventions
BIOLOGICALPRP injection
Platelet rich plasma, blood from the patient that is centrifuged.
Adipose tissue stem cells, from abdominal fat.
BIOLOGICALInjection
PRP + adipose tissue stem cells
BIOLOGICALSaline (NaCl 0,9 %) (placebo)
Sterile saline injection.
Sponsors
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KOOS (The Knee injury and Osteoarthritis Outcome Score) | Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years) | KOOS score filled out by the patient, from 0-100 where a higher score indicates worse outcomes. |
| WOMAC score (Western Ontario og McMaster Universities Osteoarthritis Index) | Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years) | Clinical outcome scores (WOMAC) filled out by the patient. Scale from 0-96 in total (0-4 on each question, added together). A higher score indicates a worse score. |
| VAS (Visual analogue scale) | Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years) | Pain score (VAS) from 0-10 where a higher score indicates worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiological findings after treatment | At inclusion and 2 years after intervention. | Cartilage status on MRI (magnetic resonance imaging) 2 years after intervention as compared with at time of inclusion |
Countries
Norway
Outcome results
None listed