Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- The rate of bone healing after spinal stenosis surgery
研究概览
简要总结
Parathyroid (PTH) hormone has been shown to enhance fracture healing in animal studies. There are so far only three published papers concerning humans. Postero-lateral fusions have shown a healing rate of less than 50% after bone. The purpose of this study is to determine if PTH 1-34 (teriparatide) improves the healing rate and the clinical course after spinal stenosis surgery.
详细描述
100 patients undergoing surgery due to spinal stenosis and intraoperatively treated with autologous bone graft, will be randomised to either 4 weeks of daily injections with teriparatide or control.
Primary outcome: The rate of healing at 6 months on CT Scans. Secondary outcomes; Pain (VAS), function (Oswestry Disability Index), quality of life (EQ-5D) at 3 and 6 months.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lumbar spinal stenosis operated on with decompression and bone grafting. All ages are accepted, but women must be postmenopausal.
排除标准
- ••dementia or psychiatric disorder
- •known malignancy < 5 years prior to fracture
- •calcium above reference value
- •signs of liver disease
- •creatinine over ref. value
- •inflammatory joint disease
- •alcohol or drug abuse
- •oral corticosteroid medication
- •long-term NSAID-treatment (=> 3 months prior to fracture)
研究组 & 干预措施
Teriparatide
One injection daily for 4 weeks
干预措施: Teriparatide (Drug)
结局指标
主要结局
The rate of bone healing after spinal stenosis surgery
时间窗: 6 months + more than 2 years postoperatively.
A radiologist, blinded to the treatment, will review all CT scans and judge whether there is a bony healing between the vertebrae.
次要结局
- Pain(At 3 and 6 months.)
- Function(At 3 and 6 months.)
研究者
Torsten Johansson
MD, PhD
University Hospital, Linkoeping