Platelet-rich Plasma in Patients With Tibiofemoral Cartilage Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change of the width of cartilage in the knee joint assessed by magnetic resonance imaging before and after nine Platelets Rich Plasma injections.
研究概览
简要总结
Recently an articular cartilage repair has been given much attention in the orthopaedic field. Cartilage regeneration capacity is very limited. Optimal approach seems to be a delivery of natural growth factors. Autologous platelet-rich plasma (PRP) contains proliferative and chemoattractant growth factors. The objective of the present study was to determine if PRP can increase tibiofemoral cartilage regeneration and improve knee function.
详细描述
Fifty consecutive and strictly selected patients, affected by Grade II or III chondromalacia, underwent one year treatment (9 injections) with autologous PRP in a liquid form with 2,0 to 2,5-fold platelets concentration. Outcome measures included hte Lysholm, Tegner, IKDC, and Cincinnati scores. Magnetic resonance imaging was used to evaluate cartilage thickness and degree of degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 31 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •isolated Grade II or Grade III nontraumatic chondromalacia according to Outerbridge grading scale
排除标准
- •Grade I (only softening) or Grade IV (exposed subchondral bone) tibiofemoral chondromalacia;
- •patellofemoral chondral damage;
- •associated intraarticular lesions confirmed during arthroscopy (menisci, ligaments, osteochondral defects);
- •associated extraarticular lesions confirmed by magnetic resonance imaging (ligaments, tendons, bursae);
- •lower limb axial deviation confirmed by whole leg weight-bearing radiograph; knee trauma in patients history;
- •body mass index (BMI) higher than 35;
- •hyaluronic acid intraarticular injection 6 months prior the arthroscopy and up to last follow-up control;
- •steroids intraarticular injection 3 months prior the arthroscopy and up to last follow-up control;
- •symptomatic slow acting drugs for osteoarthritis (SYSADOA) and/or non-steroidal anti-inflammatory drugs (NSAID) administration during the PRP treatment;
- •systemic autoimmune rheumatic and/or polyarticular disease; gout, pseudogout and hyperuricaemia.
- •Other exclusion criteria included: non-informed consent; treated knee injury during the PRP therapy; PRP injection cycle not completed; impediments to fill out the questionnaires; blood disease and/or immunosuppressant treatment and/or dicoumarol therapy; immunosuppressant and/or neoplastic and/or infectious diseases.
结局指标
主要结局
Change of the width of cartilage in the knee joint assessed by magnetic resonance imaging before and after nine Platelets Rich Plasma injections.
时间窗: 11 months after first Platelets Rich Plasma injection
50 patients with Grade II or III chondromalatia in the knee joint, underwent one year treatment with autologous Platelets Rich Plasma. Magnetic resonance imaging was used to evaluate cartilage thickness and degree of degeneration before and after the treatement of nine Platelets Rich Plasma injection.
次要结局
- Changes in the subjective and objective clinical outcomes before and after nine Platelets Rich Plasma injections.(11 months)
研究者
Komzak Martin, M.D.
Hart Radek, M.D., Ph.D., FRS, prof.; Orthopaedic- Traumatologic department
Hospital Znojmo