Louis
Marseille, 13008, France
NCT Number: NCT04352075
The hypothesis of this project is that the injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
Marseille, 13008, France
Osteoarthritis is the most common joint disease in the world and one of the most common causes of pain and functional disability. The incidence of cartilage pathology has grown due to the ageing population, and the increase in sports participation and its associated trauma. The treatment of these cartilage damage is limited and remains a major public health issue.
The aim of the medical treatment and intra articular injections consists in reducing pain and improving the knee function in order to limit the sport, professional and social negative impact in the youngest patients. Nevertheless their efficacy remain non predictable in patients.
The arthroplasty will be proposed in the final intention. Insofar arthroplasty is a surgical procedure 1 / which presents a potential infectious risk associated with its invasive nature, 2 / it requires iterative revision surgery, especially in young patients given the limited lifetime of the implants and 3 / whose complete postoperative recovery take several months, it seems justified to continue studies to validate effective alternative treatments to delay the use of joint replacements.
Recently, the emergence of biotherapy in orthopedics has developed the use of intra-articular injections of platelet-rich plasma (PRP). Their use has increased substantially and is based on the demonstration that platelet-rich plasma concentrate growth factors, can stimulate cartilage regeneration in vitro and in vivo preclinical models. In humans, recent data from the literature show that these autologous products are very well tolerated. Their scientific evaluation remains difficult in that 1 / indications and surgical procedures are not harmonized 2 / manufacturing processes PRP are not standardized 3 / quantitative and qualitative composition of PRP is rarely documented.
PRP administration procedures can be optimized: indeed in that, it is a liquid preparation (platelet suspension), its administration in a interface tissue allows to limit its spread and potentiate its trophic effect on the injured cartilage site. Adipose tissue is the most relevant interface tissue given, because it's a tissue rich in stem cells with full therapeutic potential and is easily accessible by subcutaneous minimally invasive procedure. Thus, autologous microfat (fat removed under local anesthesia by manual liposuction using fine cannulas specific) administered in the synovial capsule, could play the matrix to receive the injection of PRP.
The hypothesis of this project is that the standardized injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment. This treatment, minimally invasive and with economically reasonable cost, would provide a new treatment for second intention. In terms medicoeconomic if this treatment is effective over a period of several years, even in cases where it is necessary to do it one or two times, it would significantly reduce the financial and societal impact of joint replacements.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Articular knee injection of microfat associated with a dose of 3 billions of platelets or associated with a dose of 1 billion of platelets or with saline solution
Time frame: Baseline and 3 months post injection
The primary objective of this study is to demonstrate the efficacy of intra-articular injection of autologous microfat associated with a standardized preparation of autologous PRP, by changes in the cartilage relaxation time on MRI T2-mapping at 3 months.
Time frame: Baseline and 3 and 6 months post injection
Improved chondral lesions at 3 months and 6 months on specific MRI cartilage sequences (DP FATSAT Axial, Axial T1, T2 mapping): quantitative morphological sequences resolution and qualitative structural sequences.
Time frame: Baseline and 1 and 3 and 6 months post injection
The evolution of pain with the visual analogic scale compared to the initial state (scores at baseline) and the evolution of pain (VAS score) at 1, 3 and 6 months post-injection. Scale from 0 (no pain) to 10 (maximal pain)
Time frame: Baseline and 3 and 6 months post injection
The proportion of patients not responding to treatment.
Time frame: Baseline and 3 and 6 months post injection
The correlation between clinical efficacy and dose of PRP administered and dose of growth factors administered.
Time frame: Baseline and 1 and 3 and 6 months post injection
The evolution of the functional impact of knee osteoarthritis with the Western Ontario and McMaster University Osteoarthritis score at 1, 3 and 6 months post-injection. Score from 0 to 96 (the worst)
Clinique Juge
Other
Intra Articular Injection of Autologous Microfat and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis: a Pilot Study
Acronym: MICROPREP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07717957
Arthritis, Joint Diseases
Kuantan, Pahang, Malaysia
View Trial DetailsNCT07291791
Arthritis, Joint Diseases
Ismailia, Egypt
View Trial DetailsNCT03112200
Arthritis, Bone Marrow Edema
Encinitas, California, United States
View Trial DetailsNCT07568691
Arthritis, Balance Board
Jakarta Pusat, DKI Jakarta, Indonesia
View Trial Details