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Enrolling by invitation NCT06893250

Orthobiologic Treatment for Knee Osteoarthritis

Phase II / Phase III Interventional Osteoarthritis Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRP injection, ADSTEM Inj. (Adult human mesenchymal stem cells), Injection, Saline (NaCl 0,9 %) (placebo).
Who it may be relevant to
Registry conditions: Osteoarthritis Knee. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Orthobiologic Treatment for Knee Osteoarthritis (Ortobiologisk Behandling av Kneleddsartrose)

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.

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

  • Biological PRP injection
    Platelet rich plasma, blood from the patient that is centrifuged.
  • Biological ADSTEM Inj. (Adult human mesenchymal stem cells)
    Adipose tissue stem cells, from abdominal fat.
  • Biological Injection
    PRP + adipose tissue stem cells
  • Biological Saline (NaCl 0,9 %) (placebo)
    Sterile saline injection.

Primary outcome measures

  • KOOS (The Knee injury and Osteoarthritis Outcome Score) [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) [Time frame: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)]
  • VAS (Visual analogue scale) [Time frame: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)]
Secondary outcome measures (1)
  • Radiological findings after treatment [Time frame: At inclusion and 2 years after intervention.]

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 \<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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Treatment

Study locations

Norway · 1 center
  • University Hospital in Northern Norway — Tromsø

Identifiers

NCT: NCT06893250 · 376638

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗