NCT00243295已完成1 期
A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2/Calcium Phosphate Matrix (rhBMP-2/CPM) in Subjects With Open Wedge Osteotomies
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 6 人开始时间: 2003年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 主要终点
- Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies
研究概览
简要总结
To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters:
- Injecting the desired volume of rhBMP-2/CPM within the defect
- Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.
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
- Educational Counseling Training
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 45 to 70 years of age
- •Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee.
- •Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study.
- •Other inclusion applies.
排除标准
- •Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results.
- •Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up.
- •Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma.
- •Other exclusion applies.
结局指标
主要结局
Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies
Feasibility measures include
Injection of desired volume of rhBMP-2/CPM within the osteotomy defect
Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.
次要结局
- Safety of administering different volumes of rhBMP-2/CPM in high tibial osteotomy defects. Safety assessed by evaluation of adverse events reported during the duration of the trial.
研究者
相似试验
已完成
4 期
Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone RegenerationBone FractureNCT02609074East China University of Science and Technology81
撤回
1 期
Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary InterventionMyocardial InfarctionMitral RegurgitationNCT01156441Southern Illinois University
已完成
不适用
Omega Cuff for GERD Feasibility StudyGERD, Acid Reflux, TreatmentNCT04793035Aplos Medical6
进行中（未招募）
不适用
Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in TJAOsteoarthritis, HipRheumatoid ArthritisOsteoarthritis, KneeAvascular NecrosisNCT04910048University of Arkansas46
已完成
2 期
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)Diabetic Foot UlcersNCT01154374Skingenix, Inc.7