Prospective Evaluation of Adler Laboratory's Massive Prosthetic Implants in Oncological and Non-oncological Situations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Evaluation of prosthesis survival
研究概览
简要总结
Massive prostheses are the standard treatment for extensive bone loss, whether caused by cancer or other factors (complex fractures, multiple revisions, infections).
The emergence of modular systems such as the Pantheon range provides rapid restoration of function and precise intraoperative adaptation to anatomical constraints and specific bone loss characteristics.
The Pantheon range also offers an innovative intramedullary ring system that promotes osseointegration and potentially long-term mechanical stability of implants.
However, few studies have evaluated its clinical efficacy. In this context, a prospective cohort study is warranted in order to obtain robust data on implant survival, patient quality of life and predictors of medium- and long-term complications.
详细描述
The IMPULSION study is an observational study. The primary objective is to evaluate prosthesis survival within 5 years post-operatively.
The secondary objectives are: to evaluate functional outcomes, quality of life, the occurrence of complications, and the osseointegration of the intramedullary ring.
Patients are included during the consultation to plan the surgery. Following surgery, the patient is followed up at 1 year, 2 years and 5 years post-operatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 15 years or older at the time of inclusion
- •Surgery scheduled at one of the participating centres with an Adler implant from the list below:
- •Implants from the Pantheon prosthesis:
- •Proximal Femur Recontruction (PFR) Distal Femur Reconstruction (DFR) Proximal Tibia Reconstruction (PTR) Total Femur Reconstruction (TFR) Hybrid connector implants Custom-made implants
- •Follow-up scheduled at one of the participating centres for the duration of the study
- •Patient who has been informed about the study and does not object to participating In the case of minor patients, the patient's parents will also be informed, and their non-objection will be sought.
- •Patient affiliated with a Social Security scheme in France.
排除标准
- •Patient or parent of a minor patient who objects to participation in the study and data collection.
- •Patient deprived of liberty or under legal protection (guardianship or curatorship)
研究组 & 干预措施
Femur reconstruction Proximal (PFR)/Distal (DFR)/Total (TFR), Proximal Tibia (PTR), Custom implants
Massive prosthetic reconstruction using the Pantheon prosthesis from Adler Laboratories. The prostheses are:
- Proximal Femur Recontruction (PFR)
- Distal Femur Reconstruction (DFR)
- Proximal Tibia Reconstruction (PTR)
- Total Femur Reconstruction (TFR)
- Custom implants
结局指标
主要结局
Evaluation of prosthesis survival
时间窗: 1 year, 2 years and 5 years post-operative
The survival of the prosthesis is defined by the absence of revision surgery. This objective will be analysed in subgroups according to the type of implant used (PFR, DFR, PTR, TFR) or other implants (hybrid connector, custom-made).
次要结局
- Evaluation of functional outcomes(1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5))
- Evaluation of quality of life(1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5))
- Evaluation of complications occurring within 5 years post-operatively(1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5))
- Evaluation of osseointegration of the intramedullary ring(1 year after surgery (Y1), 2 years (Y2) and 5 years (Y5))