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Chronic Pain Canada

Knee Arthritis Treatment With Autologous Fragmented Adipose Tissue and PRP - Comparison of Two Treatment Methods

Unknown statusPhase 2NCT04321629
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This is a prospective, randomized, controlled study. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or PRP and to compare the efficacy of both therapeutic methods. We hypothesize that adipose tissue injections will improve patients' quality of life and functional status and will decrease pain level significantly more than PRP injections. In addition to the functional tests and muscle strength measurement, the patient reported outcome measures (PROMs) of the knee joint function and quality of life will be used to assess each participant. The same inclusion criteria have been established for an Experimental Group (subjects treated with autologous fat tissue) and a Control Group (subjects treated with PRP). Those criteria consist of: symptomatic knee OA, age between 45 and 65 y.o., Kellgren- Lawrence grades I - III OA, no or minimal positive effects of previous conservative treatment (rehabilitation, hyaluronic acid injections, steroid injections). Those patients who meet inclusion criteria will be allocated to Fat Tissue Group or PRP Group randomly. Patients will be assessed five times: before treatment and 1, 3, 6 and 12 months after the treatment. The PROMs consist of the four questionnaires: The Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee 2000 (IKDC 2000), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (21,22), the Health Questionnaire EQ- 5D- 5L. Moreover, three functional tests will be performed to assess patient's functional status: The Timed Up and Go Test (TUG), The 5 Times Sit to Stand Test (5xSTS), The 10m Walk Test (10mWT). To assess strength parameters of the knee flexors and extensors the Maximal Voluntary Isometric Contraction (MVIC) will be measured. Each test will be supervised by the same one physiotherapist to avoid any interexaminer bias an…

Study details

Official title
Autologous Adipose Tissue Injection Versus Platelet-rich Plasma (PRP) Injection in the Treatment of Knee Osteoarthritis: a Randomized, Controlled Study - Study Protocol
Conditions
Interventions
  • Combination product: autologous adipose tissue transfer
  • Combination product: PRP injections
Sponsor
Rehasport Clinic
Start date
2018-07-30
Primary completion
2021-12-31
Sex
All
Age range
from 45 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
Poland
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * symptomatic knee OA * Kellgren- Lawrence grades I - III OA * no or minimal positive effects of previous conservative treatment (rehabilitation, hyaluronic acid injections, steroid injections) * VAS pain level minimum 4 in one knee, VAS pain \< 2 in the contralateral knee Exclusion Criteria: * Use of local corticosteroids up to three months or hyaluronic acid injections up to six months prior to the study * Past or present joint infection * Previous knee arthroscopy surgery up to one year prior to examination * Peripheral inflammatory diseases (rheumatoid arthritis, spondyloarthropathies, etc.) * Total arthroplasty and osteotomy * Ankylosis of the joint * Dermatitis or dermatological disease at the intended injection site * Coexistence of degenerative changes in other limb joints (hip, foot) * Cancer * Oral corticosteroid therapy * Use of medicines that affect blood clotting * Pregnancy or breast-feeding

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04321629