Comparative Analysis of Radiotherapeutic and Medical Procedures for the Prophylaxis of Heterotopic Ossifications in the Context of Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 512
- 试验地点
- 1
- 主要终点
- Presence of heterotopic ossification (HO)
研究概览
简要总结
Aim of this study is to proof the efficacy of in Jena established prophylaxis of new bone formation aside the skeleton with irradiation and compare it with the common literature. Furthermore we want to compare irradiation treatment with the alternative prophylaxis with analgetics from the NSAID type.
详细描述
Aim of this retrospective analysis is to compare the incidence of heterotopic ossification one year after total hip arthroplasty with the at our location established concept of irradiation 24h preoperative and incidence in common literature. Furthermore the comparison between irradiated patients and patients treated with NSAIDs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with total hip arthroplasty performed at Eisenberg Patients with preoperative irradiation (24h pre-op) or postoperative diclofenac treatment Patients with x-ray images immediately (3-5 days postoperative) postoperative and at least 365 days postoperative
排除标准
- •Patients with missing follow up image
研究组 & 干预措施
Intervention group with prophylactic irradiation
Patients with total hip arthroplasty and irradiation (preoperative on the day before the operation (>24h preoperative)) Quantity: 128 Period: 01.01.2013 - 31.12.2023
干预措施: Radiation (Radiation)
Control group with prophylactic NSAID-treatment
Patients with total hip arthroplasty and diclofenac treatment Quantity: 384 Period: 01.01.2013 - 31.12.2023
干预措施: Diclofenac (Drug)
结局指标
主要结局
Presence of heterotopic ossification (HO)
时间窗: at least 365 days postoperative
X-ray controlled HO diagnostics with the Brooker classification
次要结局
未报告次要终点
研究者
Matthias Mäurer
Principal Investigator
University of Jena