Autologous adipose tissue injection versus platelet-rich plasma (PRP) injection in the treatment of knee osteoarthritis: a randomized, controlled study - study protocol

• Published in: BMC musculoskeletal disorders Vol. 21; no. 1; p. 314
• Main Authors: Bąkowski, Paweł, Kaszyński, Jakub, Wałecka, Joanna, Ciemniewska-Gorzela, Kinga, Bąkowska-Żywicka, Kamilla, Piontek, Tomasz
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 20-05-2020; BioMed Central; BMC
• Subjects: Adipose tissue; Adipose Tissue - transplantation; Arthritis; Autografts; Autologous subcutaneous adipose tissue; Body fat; Bone surgery; Care and treatment; Cartilage; Cartilage (articular); Cartilage diseases; Clinical Trials, Phase II as Topic; Contraction; Disease; Exercise; Humans; Injection; Injections, Intra-Articular; Intra- articular injection; Isometric; Joint surgery; Knee; Knee OA; Manipulative therapy; Medical research; Mesenchyme; Osteoarthritis; Osteoarthritis, Knee - therapy; Pain; Pain Measurement; Patient Reported Outcome Measures; Patients; Physical therapy; Platelet rich plasma; Platelet-Rich Plasma - metabolism; Platelets; Prospective Studies; Quality of Life; Questionnaires; Randomized Controlled Trials as Topic; Social interactions; Stem cell transplantation; Stem cells; Study Protocol; Treatment Outcome; Poland; Platelet rich plasma; Knee OA; Autologous subcutaneous adipose tissue; Intra- articular injection
• ISSN: 1471-2474; 1471-2474
• DOI: 10.1186/s12891-020-03345-8

Knee osteoarthritis (OA) is a common, chronic, progressive and degenerative disease which affects patients' quality of life and may cause disability and social isolation. OA is a huge economic burden for the patient and a large strain for the whole healthcare system. Articular cartilage has a small potential to repair, with progressively more clinicians emphasizing cellular therapy. Subcutaneous fat tissue in human body is a large reservoir of mesenchymal stem cells (MSCs) and is been harvested in minimally invasive, simple procedure. Up to date there is no prospective randomized controlled studies demonstrating effectiveness and role of adipose tissue injections in OA treatment. 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 platelet rich plasma (PRP) and to compare efficacy of both therapeutic methods.
This is a prospective, randomized, controlled study. Patients who meet inclusion criteria will be allocated to Fat Tissue group or PRP group randomly. Subjects will receive an intra articular injection with autologous adipose tissue and PRP respectively. Patients will be assessed five times: before treatment and 1, 3, 6 and 12 months after the treatment. The assessment consists of patient reported outcome measures (The Knee injury and Osteoarthritis Outcome Score, International Knee Documentation Committee 2000, the Western Ontario and McMaster Universities Osteoarthritis Index, the Health Questionnaire EQ- 5D- 5 L), three functional tests (The Timed Up and Go Test, The 5 Times Sit to Stand Test, The 10 m Walk Test) and Maximal Isometric Voluntary Contraction.
This study protocol has several strengths and weaknesses. One of strongest point of this study is the wide, multidimensional functional assessment which will give a large amount of objective data. On the other hand, lack of blinding has to be considered as a risk of both subject and investigator bias.
name of registry: ClinicalTrials.gov, trial registration number: NCT04321629, retrospectively registered on date of registration.