Randomized, Double-blind Study for the Treatment of the Bone Marrow Edema:Core Decompression Versus (VS) Subchondral Injections of Autologous BMC VS Subchondral Injections of Bone Substitute
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- change of Visual Analogue Scale (VAS) score
研究概览
简要总结
Randomized, controlled, three-arm, double-blind study : control group, treated with core decompression technique VS subchondral plasty by injecting i-FactorTM VS injections of autologous BMC.
详细描述
The clinical trial is a randomized, controlled, three-arm, double-blind study, involving up to 120 patients. Eligible subjects will be randomly allocated to one of the three treatment groups: control group, treated with core decompression technique, study group 1, treated with subchondral plasty by injecting i-FactorTM, and study group 2, treated by injections of autologous BMC.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients between 18 and 75 years;
- •Symptomatic subchondral bone marrow lesions of femoral condyles (grade ≥ 1 according to the WORMS MRI score);
- •Failure after at least two months of a conservative treatment;
- •Single BME areas involving a single compartment of the knee;
- •Availability of the patients to participate actively in the rehabilitation protocol and follow-up clinic and radiology;
- •Signature of informed consent.
排除标准
- •Patients incapable of discernment;
- •History of allergy to calcium phosphates;
- •Patients with malignancies;
- •Patients with rheumatic diseases;
- •Patients with diabetes;
- •Patients suffering of metabolic disorders of the thyroid;
- •Patients with history of abuse of alcohol, drugs or medication;
- •Patients with advanced osteoarthritis (Kellgren-Lawrence grade> 3);
- •Body Mass Index> 35;
- •BME that involve more than one compartment;
- •Patients with trauma in the 6 months prior to the intervention. -
研究组 & 干预措施
core decompression technique
The standard surgical technique is the subchondral anterograde drilling, which permit a revascularization of the Bone Marrow Edema (BME) and a reduction of the intramedullary pressure (core decompression).
干预措施: core decompression (Procedure)
bone substitution (i-FactorTM)
i-FactorTM is a combination of the mineral component of bone (Anorganic Bone Mineral) with a peptide replicating the cell-binding domain of Type-I collagen (P-15). It has been used in bone defects and in spine fusion providing good clinical results. Thus, i-FactorTM could be a valid and efficient bone substitute to treat BMLs with subchondral injections.
干预措施: bone substitute i-FactorTM (Biological)
injections of autologous Bone Marrow Concentrate (BMC)
injections of autologous BMC.
干预措施: autologous bone marrow concentrate (Biological)
结局指标
主要结局
change of Visual Analogue Scale (VAS) score
时间窗: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
improvement in VAS score from baseline to follow up
次要结局
- Knee Injury and Osteoarthritis Outcome (KOOS) Score([Timepoint: Screening, 1 , 3 6, 12, 24 months])
- Tegner Activity Level Scale([Timepoint: Screening, 1 , 3 6, 12, 24 months])
- International Knee Documentation Committee (IKDC) subjective score([Timepoint: Screening, 1 , 3 6, 12, 24 months])
研究者
Federica Balboni
Sub-Investigator
Istituto Ortopedico Rizzoli