Orthobiologic Treatment for Knee Osteoarthritis

March 17, 2025 updated by: University Hospital of North Norway

Orthobiologic Treatment for Knee Osteoarthritis (Ortobiologisk Behandling av Kneleddsartrose)

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Tromsø
      • Tromso, Tromsø, Norway, 9038
        • University Hospital in Northern Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Platelet rich plasma (PRP)
Plasma taken from the patient is centrifuged and isolated before it is injected into the patients knee.
Biological: PRP injection
Platelet rich plasma, blood from the patient that is centrifuged.
Other Names:
  • PRP
  • Platelet rich plasma
Active Comparator: Adipose tissue stem cells
Adipose tissue is taken from the patients abdominal subcutaneous fat tissue and is injected into the knee.
Biological: ADSTEM Inj. (Adult human mesenchymal stem cells)
Adipose tissue stem cells, from abdominal fat.
Other Names:
  • Mesenchymal stem cells
  • Adipose tissue stem cells
Active Comparator: Platelet rich plasma + adipose tissue stem cells
A combination of platelet rich plasma and adipose tissue stem cells are taken from the patient and injected into the patients knee.
Biological: Injection
PRP + adipose tissue stem cells
Other Names:
  • PRP
  • Adipose tissue stem cells
Placebo Comparator: Placebo (saline)
Saline (NaCl) is injected into the patients knee.
Biological: Saline (NaCl 0,9 %) (placebo)
Sterile saline injection.
Other Names:
  • saline
  • placebo
  • NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
KOOS score filled out by the patient, from 0-100 where a higher score indicates worse outcomes.
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)
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.
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)
Pain score (VAS) from 0-10 where a higher score indicates worse outcomes.
Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological findings after treatment
Time Frame: 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
At inclusion and 2 years after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 376638

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only main scientists in the project will have access to IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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