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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet rich plasma (PRP) | Active Comparator | Plasma taken from the patient is centrifuged and isolated before it is injected into the patients knee. |
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| Adipose tissue stem cells | Active Comparator | Adipose tissue is taken from the patients abdominal subcutaneous fat tissue and is injected into the knee. |
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| Platelet rich plasma + adipose tissue stem cells | Active Comparator | A combination of platelet rich plasma and adipose tissue stem cells are taken from the patient and injected into the patients knee. |
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| Placebo (saline) | Placebo Comparator | Saline (NaCl) is injected into the patients knee. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP injection | Biological | Platelet rich plasma, blood from the patient that is centrifuged. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological findings after treatment | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital in Northern Norway | Tromsø | Tromsø | 9038 | Norway |
Only main scientists in the project will have access to IPD.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D002712 | Chlorides |
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| ADSTEM Inj. (Adult human mesenchymal stem cells) | Biological | Adipose tissue stem cells, from abdominal fat. |
|
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| Injection | Biological | PRP + adipose tissue stem cells |
|
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| Saline (NaCl 0,9 %) (placebo) | Biological | Sterile saline injection. |
|
|
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |