'A Randomized Clinical Trial on the Clinical Efficacy of Bone Marrow Stimulation Combined With the Insertion of Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Small Primary and Non-primary Talar Osteochondral Lesions'
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Numeric Rating Scale of Pain During Weightbearing
研究概览
简要总结
Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed conservative management, surgical intervention may be necessary. For small cystic defects the current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell population from the underlying bone marrow. This procedure has been reported to have a 75% successful long-term outcome. Recently, the additional use of biological adjuncts has become popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may therefore theoretically improve the quality of subchondral plate and cartilage repair. The current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in comparison to BMS alone.
详细描述
Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed conservative management, surgical intervention may be necessary. For small cystic defects the current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell population from the underlying bone marrow. This procedure has been reported to have a 75% successful long-term outcome. Recently, the additional use of biological adjuncts has become popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may therefore theoretically improve the quality of subchondral plate and cartilage repair. The current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in comparison to BMS alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a symptomatic OCL of the talus who are scheduled for arthroscopic debridement and microfracture
- •OCL depth and/or diameter ≤ 15 mm on computed tomography medial-lateral and/or anterior-posterior
- •Age 18 years or older
- •Intact remaining articular cartilage of the joint Kellgren-Lawrence stage 0-1
排除标准
- •Concomitant OCL of the tibia
- •Ankle osteoarthritis grade 2 or 3 van Dijk et al. [53]
- •Ankle fracture < 6 months before scheduled arthroscopy
- •Inflammatory arthropathy (e.g Rheumatoid arthritis)
- •History of (or current) hemopoeitic disease or immunotherapy
- •Acute or chronic instability of the ankle
- •Use of prescribed orthopaedic shoewear
- •Other concomitant painful or disabling disease of the lower limb
- •Pregnancy
- •Implanted pacemaker
- •Participation in previous trials < 1 year, in which the subject has been exposed to radiation (radiographs or CT)
- •Patients who are unable to fill out questionnaires and cannot have them filled out
- •No informed consent
- •HIV positive or hepatitis B or C infection (based on the anamnesis of the patient)
结局指标
主要结局
Numeric Rating Scale of Pain During Weightbearing
时间窗: 2 years post-operatively
次要结局
- EQ5D(two years post-operatively)
- AOFAS(two years post-operatively)
- FAOS(two years post-operatively)
- NRS in rest(2 years postoperatively)
- FAAM(2 years postoperatively)
- NRS during running(2 years postoperatively)
- NRS during stair-climbing(2 years postoperatively)
- NRS during performing sports(2 years post-operatively)
- NRS during weight-bearing(1 year post-operativley)
- SF-12(2 years postoperatively)
- Ankle Activity Scale (AAS)(2 year post-operatively)
- Return to sports(post-operatively until 2 years of follow-up post-operatively)
- Return to work(post-operatively until 2 years of follow-up post-operatively)
- Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)(2 years postoperatively)
- Cost-effectiviness(From per-operatively to post-operatively at 2 years (one period))
- Cell-subset analysis(per-operatively)
- Demographic data(Pre-operatively)
- Complications(From per-operatively to post-operatively at 2 years (one period))
- Re-operations(From per-operatively to post-operatively at 2 years (one period))
- Radiological outcomes: MRI scan (T2 relaxation times)(2 years post-operatively)
研究者
Jari Dahmen
MD, BSc
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)