NCT01305356已完成不适用
A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
BioMimetic Therapeutics25 个研究点 分布在 2 个国家目标入组 299 人开始时间: 2011年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 299
- 试验地点
- 25
- 主要终点
- Pain on Weight Bearing
研究概览
简要总结
STUDY OBJECTIVES:
To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions)
STUDY HYPOTHESIS:
Augment® Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness
STUDY RATIONALE:
To evaluate a fully synthetic bone graft material to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as Autologous Bone Graft without necessitating an additional invasive procedure to harvest the graft
详细描述
STUDY DESIGN:
Prospective, randomized, controlled, non-inferiority, multi-center trial
NUMBER OF STUDY CENTERS:
25
NUMBER OF SUBJECTS:
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 (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
- •at least 18 years old and considered skeletally mature
- •diagnosed with degenerative joint disease (DJD) affecting the hindfoot due to a congenital or acquired deformity, osteoarthritis, rheumatoid arthritis, post- traumatic arthritis or ankylosing spondylitis of the ankle, subtalar, calcaneocuboid, and/or talonavicular joints
- •requires one of the following hindfoot fusion proceduress with supplemental bone graft/substitute: ankle fusion (tibiotalar), subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints) OR double fusions (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints)
- •fusion site able to be rigidly stabilized with no more than 3 screws across the fusion site
- •supplemental pins or staples allowed
- •supplemental screws external to the fusion site(s) allowed
- •signed informed consent document, independent, ambulatory, and can comply with all post-operative evaluations and visits
排除标准
- •undergone previous fusion surgery at the proposed location, i.e., revision of a failed fusion
- •more than one previous procedure at the involved joints
- •retained hardware spanning the joint(s) intended for fusion
- •procedure anticipated to require plate fixation (including claw plates), IM nails or more than 3 screws to achieve rigid fixation based on pre-op planning
- •procedure expected to require more than 9cc of graft material based on pre-op planning
- •procedure expected to require structural bone graft, allograft, bone graft substitute, platelet rich plasma (PRP) or bone marrow aspirate
- •procedure expected to require a pantalar fusion, i.e., fusion of ankle plus all hindfoot joints (talonavicular, subtalar, and calcaneocuboid) or an ankle fusion in combination with any hindfoot fusion
- •radiographic evidence of bone cysts, segmental defects or growth plate fracture near the fusion site that could negatively impact the proposed fusion procedure
- •tested positive or been treated for a malignancy in the past or is suspected of having a malignancy or currently undergoing radio- or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed surgical site
- •pre-existing sensory impairment, e.g., diabetics with baseline sensory impairment, which limits ability to perform objective functional measurements and may be at risk for complications
- •- diabetics not sensitive to the 5.07 monofilament (Semmes-Weinstein) are to be excluded
- •metabolic disorder known to adversely affect the skeleton other than primary osteoporosis or diabetes, e.g., renal osteodystrophy or hypercalcemia
- •use of chronic medications known to affect the skeleton, e.g., glucocorticoid usage > 10mg/day
- •pre-fracture neuromuscular or musculoskeletal deficiency which limits the ability to perform objective functional measurements
- •physically or mentally compromised, e.g., current treatment for a psychiatric disorder, senile dementia, Alzheimer's disease, etc., to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant
- •allergic to yeast-derived products or bovine collagen or other bovine-sourced products
- •received an investigational therapy within 30 days of proposed surgery or during the follow-up phase of the study
- •is a prisoner, known or suspected transient or a history of drug/alcohol abuse within the 12 months prior to screening
- •pregnant or intending to become pregnant within 12 months of the study procedure
- •morbidly obese defined as BMI > 45 kg/m2
- •currently has an acute infection at the surgical site
研究组 & 干预措施
Augment® Injectable Bone Graft
Experimental
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
干预措施: Augment® Injectable Bone Graft (Device)
Autologous bone graft
Active Comparator
Standard Rigid Fixation + Autologous bone graft
干预措施: Autologous bone graft (Procedure)
结局指标
主要结局
Pain on Weight Bearing
时间窗: Baseline, 9, 12, 16, 24, 36, and 52 weeks
Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
次要结局
- AOFAS Hindfoot and Ankle Score(Baseline, 9, 12, 16, 24, 36, and 52 weeks)
- Fusion Site Pain(Baseline, 9, 12, 16, 24, 36, and 52 weeks)
- Foot Function Index (FFI)(Baseline, 9, 12, 16, 24, 36, and 52 weeks)
- SF-12 Physical Component Score(Baseline, 9, 12, 16, 24, 36, and 52 weeks)
研究者
研究点 (25)
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