The Use of APSI: Long Term Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Radiographic outcome
研究概览
简要总结
Scaphoid proximal pole fracture with avascular necrosis is a complex surgical problem. In some cases, it's possible to perform a scaphoid hemiarthroplasty with an adaptative proximal scaphoid implant (APSI), made of pyrocarbon, replacing the necrotic proximal pole. APSI allows an early mobilization of the wrist, an optimal recovery of strength and a rapid return to normal daily and work activities without limitations. This implant delays palliative and more invasive surgical treatments in patients that are generally young with high functional demands. The investigators have performed a long-term follow up (with a mean follow-up of 17 years) of the early cases of APSI implant performed, starting from 1999. Radiographic and clinical strength recovery, along with subjective outcomes, have been shown to be good, with a rapid return to daily and work activities, indicating that APSI implants are a good alternative to traditional and invasive techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who underwent APSI implant surgery in the period from December 1999 to December 2016, with surgery performed via dorsal or volar approach in the case of previous surgical access;
- •collection of informed consent to the processing of personal data by the Patients contacted in order to be included in the study.
排除标准
- •patients for whom it was not possible to obtain informed consent to the processing of personal data.
研究组 & 干预措施
Long term follow-up of patients treated with APSI
Long-term clinical and radiographic outcomes in patients undergoing APSI (Adaptive Proximal Scaphoid Implant); evaluation of wrist strength and ROM (Range of Motion) on the operated side compared with the healthy side; evaluation of daily, work and sports autonomy with DASH (Disabilities of the Arm, Shoulder, and Hand) and PRWE (Patient Rated Wrist Evaluation) questionnaires and evaluating the return to normal daily, work and sports activities pre-surgery; quantification of pain at the site of surgery.
干预措施: APSI prosthesis implant (Device)
结局指标
主要结局
Radiographic outcome
时间窗: Through study completion, an average of 17 year
X-Rays showed that all the implants were correctly positioned, without any particular or evident erosion of the surrounding bone structures. A pattern of moderate or non-severe degree of arthrosis of the wrist could generally be found. By comparing the X-rays taken at the follow-up, it was possible to detect a general slight evolution of the arthritic in the wrist compared to what was visible at the beginning of the treatment, in all the patients.
次要结局
- DASH (Disabilities of the Arm, Shoulder, and Hand)(Through study completion, an average of 17 year)
- PRWE (Patient Rated Wrist Evaluation)(Through study completion, an average of 17 year)
- VAS (Visual Analogue Scale)(Through study completion, an average of 17 year)
研究者
Massimo Corain
Director, Head of Hand Surgery Unit, Principal Investigator
Azienda Ospedaliera Universitaria Integrata Verona