Knee Osteoarthritis Clinical Trial
Official title:
Autologous Adipose Tissue Injection Versus Platelet-rich Plasma (PRP) Injection in the Treatment of Knee Osteoarthritis: a Randomized, Controlled Study - Study Protocol
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 and discrepancies during testing.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Rehasport | Poznan | Wielkopolska |
Lead Sponsor | Collaborator |
---|---|
Rehasport Clinic |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in The Knee injury and Osteoarthritis Outcome Score (KOOS) | The answers are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated. | 1, 3, 6 and 12 months after the treatment | |
Primary | Change in the International Knee Documentation Committee 2000 (IKDC 2000) score | The IKDC contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 1, 3, 6 and 12 months after the treatment | |
Primary | Change in tthe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score | Due to no polish version of the WOMAC score, it will be calculated from KOOS score. Higher scores represent worse pain, stiffness, and functional limitations. | 1, 3, 6 and 12 months after the treatment | |
Primary | Change in the quality of life score (EQ- 5D- 5L) | The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Scores range from 5 points (highest level of function and lowest level of symptoms) to 25 points (lowest level of function or highest level of symptoms). |
1, 3, 6 and 12 months after the treatment | |
Primary | Change in functional status according to The Timed Up and Go Test (TUG) | The result of this test is time measured with stopwatch. Time limit for this test is 3 minutes 30 seconds. Less time means better result. | 1, 3, 6 and 12 months after the treatment | |
Primary | Change in functional status according to The 5 Times Sit to Stand Test (5xSTS) | The result of this test is time measured with stopwatch. The stopwatch is stopped when the subject sits down after the fifth repetition. Less time means better result. | 1, 3, 6 and 12 months after the treatment | |
Primary | Change in functional status according to The 10m Walk Test (10mWT) | The result of this test is time measured with stopwatch. The patient is not allowed to run but may use the crutches or a walker if needed. Less time means better result. | 1, 3, 6 and 12 months after the treatment | |
Secondary | Strength parameters | Strength parameters of the knee flexors and extensors the Maximal Voluntary Isometric Contraction (MVIC) | 1, 3, 6 and 12 months after the treatment |
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