Evaluation of the Clinical and Radiological Outcome of Uncemented Femoral Stems According to Their Proximal Coating.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- Engh and Massin Score
研究概览
简要总结
Evaluation of the clinical and radiological outcome of uncemented femoral stems according to their proximal coating.
Retrospective study
详细描述
On a large population of patients having undergone total hip arthroplasty, divided into two cohorts constituted according to the type of femoral stem implanted (with or without proximal coating by MectaGrip):
Primary objective: To compare between the two groups the radiological osseointegration of the stems five years after arthroplasty.
Secondary objectives: To compare between the groups
- The functional outcome of the arthroplasty
- The frequency of radiological abnormalities (stress shielding, osteolysis, periprosthetic fractures or cracks, periprosthetic ossifications)
- Frequency of complications
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Patient aged 18 years or older, having been informed of the research
- •A patient with at least five years of uncemented total hip replacement implanted as a first-line procedure
- •A patient who has been regularly monitored since surgery and for whom all clinical and radiological data are available at the five-year follow-up visit
排除标准
- •Patient operated for revision
- •History of femoral fracture (pre or per operative)
- •Chronic treatment likely to affect calcium metabolism and ossification
- •Patient under legal protection, guardianship or curatorship
- •A patient who has indicated his or her opposition to the use of his or her medical data (by completing and returning the non-opposition form that will be sent to him or her).
结局指标
主要结局
Engh and Massin Score
时间窗: 5 years
The osseointegration of each stem will be assessed by the Engh and Massin score which evaluates the fixation (bone margins and bridges) and the stability of the stem (margins, pedestal, remodelling of the calcar, deterioration of the prosthesis-bone interface, migration, and particles) by associating negative or positive values for each of the parameters. The total constitutes an anatomopathological diagnosis of "confirmed bone rehab" (+ 10 pts and more), suspected (between 0 and + 10 pts), "fibrous encapsulation" (between - 10 and 0 pts) or an "unstable" prosthesis (below - 10 pts).
次要结局
- Stability of the femoral stem: axial migration (sinking)(5 years)
- Stability of the femoral stem: frontal migration (varisation)(5 years)
- Gruen's zones assessment(5 years)
- Forgotten Joint Score(5 years)
- Life span of prostheses(5 years)
- Oxford hip score(5 years)
- Periprosthetic ossifications (Brooker classification)(5 years)
- Periprosthetic fractures (Vancouver classification)(5 years)
- Harris Hip Score (HHS)(5 years)