Orthobiologic Treatment for Knee Osteoarthritis

Phase 3Enrolling By InvitationNCT06893250

University Hospital of North Norway160 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Osteoarthritis Knee

Interventions

PRP injectionBIOLOGICAL

Platelet rich plasma, blood from the patient that is centrifuged.

ADSTEM Inj. (Adult human mesenchymal stem cells)BIOLOGICAL

Adipose tissue stem cells, from abdominal fat.

InjectionBIOLOGICAL

PRP + adipose tissue stem cells

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital in Northern Norway

Tromsø, Tromsø, Norway

Outcomes

Primary Outcomes

KOOS (The Knee injury and Osteoarthritis Outcome Score)

KOOS score filled out by the patient, from 0-100 where a higher score indicates worse outcomes.

Time frame: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)

WOMAC score (Western Ontario og McMaster Universities Osteoarthritis Index)

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.

Time frame: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)

VAS (Visual analogue scale)

Pain score (VAS) from 0-10 where a higher score indicates worse outcomes.

Time frame: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)

Secondary Outcomes

Radiological findings after treatment

Cartilage status on MRI (magnetic resonance imaging) 2 years after intervention as compared with at time of inclusion

Time frame: At inclusion and 2 years after intervention.

Data from ClinicalTrials.gov

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