NCT01283737撤回4 期
A Randomized, Subject-blind, Controlled Pilot Trial to Evaluate the Effectiveness and Safety of the Use of Demineralized Bone Matrix (DBX®) Versus Mosaicplasty in the Treatment of Late-Stage Osteochondritis Dissecans (OCD) of the Knee in Patients With a Mature Skeleton
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Synthes GmbH
- 试验地点
- 1
- 主要终点
- Change of Brittberg-Peterson functional assessment score from baseline until 12 months post-op
研究概览
简要总结
This is a 1:1 randomised pilot study in 30 patients in 1 site in Helsinki, Finland.
The investigators hypothesize that function, pain, type and quality of cartilage in adult patients with osteochondritis dissecans of the knee will be better in the DBX group compared to the mosaicplasty group.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, age between 18 years and 65 years
- •Females of childbearing potential must have a negative serum or urine pregnancy test at the time of inclusion
- •Females of childbearing potential must be willing to use effective means of birth control for at least 1 year post surgery. Medically acceptable contraceptives include:
- •Surgical sterilisation
- •Approved hormonal contraceptives
- •Barriers methods combined with a spermicide
- •An intrauterine device
- •Abstinence alone is not considered an acceptable method of contraception
- •Late stage Osteochondritis Dissecans (ICD-10 code M93.2) of the knee classified as stage III or IV (Anderson MRI classification)
- •Mature skeleton
- •Written informed consent prior to any study specific procedures (except the procedures necessary to determine eligibility)
- •Ability and willingness to comply with all study specific procedures, including attending all follow-up visits up to 12 months postoperative and completing questionnaires in a local language
排除标准
- •More than 1 knee affected
- •Patients who can be treated with conservative treatment alone, unless there is evidence of at least 6 months failed previous treatment
- •Systemic disease including AIDS, HIV, Hepatitis or any other disease that would prevent normal organ and marrow function.
- •Patients undergoing systemic cortisone treatment or immunosuppressive therapy (e.g. avascular necrosis)
- •Patients undergoing active cancer therapy (chemotherapy, radiation treatment).
- •History of alcohol abuse or illegal drug use.
- •Participation in any other device or drug trial within 3 months prior to the inclusion in the study
- •Presence of at least one contraindication for DBX® Putty
结局指标
主要结局
Change of Brittberg-Peterson functional assessment score from baseline until 12 months post-op
时间窗: At enrollment (day -7), at full weight-bearing (6-8 weeks post-operative), 6 months post-operative, 12 months post-operative
Score 0-130 (see Clin Orthop Relat Res 2000 May;374:212-34) to assess function and pain
次要结局
- Number of patients with complications to assess the safety of the use of the treatment(Enrolment (day -7) until 12 months post-operative)
- Type and quality of the formed cartilage to assess the effectiveness of the treatment(12 months post-operative)
研究者
研究点 (1)
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