NCT00551941终止4 期
A Prospective Randomised Controlled Trial on the Use of BMP-7 (OP-1®) and Demineralised Bone Matrix in Tibial Non-union
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in VAS and LEFS scores
研究概览
简要总结
The researchers propose a prospective, randomised partially-blinded study to investigate the clinical and radiological outcome, effect on quality of life and socio-economic impact of non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft, in comparison to treatment with allograft together with DBM (demineralised bone matrix).
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
- Double (Participant, 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
- •Diaphysary tibial non-unions will be included (9 months after first surgery)
- •Major surgery includes exchange nailing, bone grafting, internal fixation, amputation and soft-tissue coverage procedures, such as delayed primary closure and free flaps
- •Surgery is classified as minor for removal of external fixator pins for local infection and removal of a static locking screw from intramedullary nails, a procedure known as dynamization
- •ASA 1 and ASA 2
- •Gap length/bone contact detected (1-5 cm): largest cortical gap in any radiographic incidence
- •Subject or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent, which has been approved by the Institutional Review Board
- •Agrees to participate in post-operative evaluations and required rehabilitation regimen
排除标准
- •Patients with known hypersensitivity to the active substance or collagen
- •Gap more than 5 cm
- •Immature skeleton
- •Known auto-immune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis
- •Active infection on unhealed site or active systemic infection
- •Non-healing resulting from pathological fractures, tumours or metabolic bone diseases
- •Presence of tumour in vicinity of non-union
- •Patients receiving chemotherapy, radiotherapy or immunosuppressant treatment or excessive steroids
- •Patients with severely compromised soft tissue coverage or vascularisation at the non-union site, sufficient to impair bone healing
- •Patients with congenital non-union
- •Pregnancy and lactation
- •Non-union of multiple bones interfering with walking
- •Patients with neuromuscular diseases or conditions interfering normal weight bearing
- •Patients who, judged by the surgeon, are candidates for just internal fixation alone
研究组 & 干预措施
2
Active Comparator
non-union of diaphysary tibial fractures will be treated with allograft together with DBM
干预措施: allograft together with DBM (Procedure)
1
Experimental
non-union of diaphysary tibial fractures will be treated with BMP-7 in adjunct to fresh frozen allograft
干预措施: BMP-7 in adjunct to fresh frozen allograft (Procedure)
结局指标
主要结局
Change in VAS and LEFS scores
时间窗: After 9 months
X-ray evaluation
时间窗: After 9 months
次要结局
- Change in SF-36(After 4 years)
- Total socio-economic cost estimation(After 4 years)
- Time of incapacity to work(Until ability to work)
- Repeated surgery (minor and major)(After 4 years)
- (Surgical) complications(After 4 years)
- Ability to bear weight (% of body weight)(After 4 years)
研究者
研究点 (2)
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