NCT06699160撤回不适用
Post Market Clinical Follow-up Study on the Refobacin Revision-3 Bone Cement and Its Instrumentation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Survivorship
研究概览
简要总结
The goal of this post-market study is to confirm the safety, performance and clinical benefits of the Refobacin Revision-3 Bone Cement when used in knee or hip revision surgeries. This will be done by collecting information on:
- removal of any metal components of the hip or knee implants used in combination with the cement
- frequency and incidence of adverse events
- overall pain and functional performance, subject quality of life, and radiographic parameters
详细描述
Multicenter, retrospective and prospective, non-controlled Post-Market Clinical Follow-Up (PMCF) study involving orthopedic surgeons skilled in knee or hip arthroplasty procedures.
Patients will be enrolled prospectively or retrospectively (minimum 3 years after their surgery, depending on the availability of the data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 is 18 years or older and skeletally mature.
- •Patient is capable of understanding the surgeon's explanations and following his/her instructions, able and willing to participate in the follow-up program.
- •Patient gave consent to take part in the study by signing the Ethics Committee approved Informed Consent Form (ICF).
- •Patient who underwent or will undergo a hip or knee revision surgery with a Zimmer Biomet implant and the Refobacin® Revision-3 Bone Cement.
- •Patient meets at least one of the following indications, as stated in the Instructions for Use (IFU):
- •Patients requires a revision operation resulting from aseptic loosening of the prosthesis and/or infection of the prosthesis by gentamicin and/or clindamycin sensitive strains.
- •Patients undergoing a two-stage revision that requires the fabrication and fixation of short-term total or hemi joint StageOne™ spacers. The device is intended for use in conjunction with systemic antimicrobial therapy (standard approach to an infection).
- •Additional inclusion criteria for patients receiving a StageOne™ spacer, as stated in the IFU:
- •Implantation period of a maximum of 180 days.
- •The molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
排除标准
- •Patient is unwilling or unable to give consent or to comply with the follow-up program.
- •Patient is known to be pregnant or breastfeeding.
- •Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study.
- •Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
- •Patient has plans to relocate during the study follow-up period.
- •As stated in the IFU, patient with known hypersensitivity to gentamicin and/or clindamycin and/or to other constituents of the bone cement.
- •Additional exclusion criteria for patients receiving a StageOne™ spacer, as stated in the IFU:
- •The infected Total Hip/Knee Replacement (THR/TKR) devices cannot be removed.
- •A systemic or secondary remote infection is expected or confirmed.
- •Lack of adequate bone structure precludes adequate support of the prosthesis in the proximal femur or acetabular region, or
- •Lack of adequate competence (anatomical and functional) of peripheral ligamentous apparatus and extensor mechanism.
- •The patient is sensitive (allergic) to aminoglycosides.
结局指标
主要结局
Survivorship
时间窗: 3, 5 and 10 years post-operatively
* removal of any metal components of the hip or knee implants used in combination with the cement * frequency and incidence of adverse events
次要结局
- EuroQuol 5D (EQ-5D) Score(1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective))
- Harris Hip Score / Knee Society Score(1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective))
- Radiographic evaluation(1, 3, 5 and 10 years post-operatively (retrospective, if available, or prospective))
研究者
研究点 (1)
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