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.
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.
Lipoaspiration procedure Lipoaspiration will take place in the operating room under general
anesthesia for patient's and doctor's comfort. The most frequent donor site is abdomen
(14,15). The patient will be placed in a supine position. At first, two small incisions at
the level of umbilicus will be made by the trained orthopaedic surgeon (TP or PB). Then Klein
solution (saline with lidocaine and epinephrine) will be infused to reduce bleeding. Ten
minutes is required for infiltration. Next step is a liposuction performed with a thin
cannula inserted through incisions. Finally, skin sutures and the pressure dressing will be
applied. To minimize risk of bleeding and hematoma, an elastic belt will be recommended, as
well as partial weight bearing within first two weeks. Harvested adipose tissue will be
prepared in a Lipogems kit (14). The final product will be transferred into 10-ml syringes.
About 10 ml of the product will be injected into the affected knee joint.
PRP procedure PRP preparation takes place in an outpatient clinic. 10-ml sterile collecting
tubes containing citrate will be placed in a centrifuge (Centrifuge MPV- 223e) with a tilting
rotor. Rotation will last 7 minutes at 2054 rounds per minute. After centrifugation, PRP will
be collected up to 3 ml for separate 10-ml syringe. 3 ml of PRP will be injected into the
knee joint. Procedure will be repeated three times in 7 day interval.
Injection procedure Joint injection will be performed by TP or PB in the same manner for both
groups: patient placed in supine position, affected knee extended, a 21-Gauge needle inserted
into the suprapatellar pouch, in case of joint effusion - aspiration of synovial fluid and
finally administration of autologous fat tissue or PRP.
This study protocol has several strengths and weaknesses. Undoubtedly one of strongest point
of this study is wide, multidimensional functional assessment, which will give a large amount
of objective data. To our knowledge, this research is the first one which includes the
battery of functional tests and MVIC as an outcome measurement tool. This study will use 4
questionnaires, including WOMAC, which is described by physicians as a gold standard for
assessing the effectiveness of knee OA treatment (47,48).
On the other hand this study has several limitations. Primarily - the lack of blinding and we
consider this as a risk of both, subject and investigator bias. Next and equally important
limitation is a small size of the study. Furthermore, autologous fat tissue procedure is
definitely more invasive and more stressful for the patients than PRP procedure. Hence,
taking all into consideration, to adopt autologous fat tissue as a knee OA therapy, based on
the future results, we have to detect definite, statistically significant and clinically
noticeable difference.
Our PRP procedure gives us the possibility to examine the patient and assess the reaction to
intra- articular injection 3 times (3 injections) in 7 day interval. These visits are often
associated with physical therapy, which consists of manual therapy and individualized
exercise program. Autologous fat tissue procedure does not give us such a possibility. The
doctor and physiotherapist see the patient on the day of the surgery and two weeks after,
during a control visit, which is also associated with physical therapy. Thus, there are some
discrepancies between the two procedures at the beginning of the treatment process.
It has been proven that intra- articular injection of autologous fat tissue or PRP is a
safety treatment option of knee OA (49,50). The most common complications after the intra-
articular injection are pain and swelling of treated knee, but this improve after cold
compression and NSAIDs. Also there were no cancer incidents reported after autologous fat
tissue or PRP implantation(50).
Subject recruitment has started after we received Bioethical Committee approval.
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