Prospective, Multicentre Study to Assess Performance of the Mpact 3D Metal MonoCer Cup Implant in Primary Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Survival rate at 2 years compared to all other acetabular cups utilising AOANJRR data revision rates.
研究概览
简要总结
This study titled "Prospective, Multicentre Study to Assess Performance of the MonoCer Acetabular Cup in Primary Total Hip Replacement" is a multi-centre prospective registry-nested cohort study, using AOANJRR's web-based data collection system integrated with Registry data collection, designed to assess the ten-year clinical outcome of the MonoCer Acetabular Cup in Primary Total Hip Replacement. The primary outcome measure is mortality and secondary measures are PROMs and complications.
详细描述
This study titled "Prospective, Multicentre Study to Assess Performance of the MonoCer Acetabular Cup in Primary Total Hip Replacement" is a multi-centre prospective registry-nested cohort study, using AOANJRR's web-based data collection system integrated with Registry data collection, designed to assess the ten-year clinical outcome of the MonoCer Acetabular Cup in Primary Total Hip Replacement. The primary outcome measure is mortality and secondary measures are PROMs and complications.
The purpose and objectives of this study are to assess and document the clinical outcomes in a group of primary total hip arthroplasty patients having this surgery for the management of end-stage osteoarthritis. Survivorship and changes in pain and function as well as death will be assessed. The design of this study will also allow, if required the continued follow-up after the initial 2 years to determine mid and long-term survivorship and performance of this cohort.
All patients will receive primary hip arthroplasty standard of care (pre and post operatively) as defined by each participating surgeon. In addition to the Medacta MonoCer Acetabular Cup. There shall be no investigational, experimental or "off-label" use of the device. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labelling.
A prospective study will be conducted using the AOANJRR web-based data collection system (RAPID). Eligible and consented participants are registered in the RAPID system. The PROMs will be completed by patients via the RAPID system.
• Surgeons will determine patient eligibility, providing informed consent prior to enrolment and registration in RAPID.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a primary total conventional hip replacement and are suitable for cementless acetabular cup according to the indications for use (On-label use).
- •Use of the Medacta Mpact 3D Metal MonoCer acetabular cup prosthesis.
- •Adults aged between 18 and 75 years at the time of registration.
- •Ability to give informed consent.
- •Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.
排除标准
- •Exclusion Criteria
- •Rheumatoid arthritis.
- •Patients with a history of active infection.
- •Any case not described in the inclusion criteria.
- •Revision procedures.
结局指标
主要结局
Survival rate at 2 years compared to all other acetabular cups utilising AOANJRR data revision rates.
时间窗: 2 years
Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.
Survival rate at 5 years compared to all other acetabular cups utilising AOANJRR data revision rates.
时间窗: 5 years
Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.
Survival rate at 10 years compared to all other acetabular cups utilising AOANJRR data revision rates.
时间窗: 10 years
Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates. Analysis of reasons for revisions.
次要结局
- Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with EQ-5D-5L(pre-op, 6 months, 1 year, 2 years, 5 years, 10 years)
- Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with OHS(pre-op,6 months, 1 year, 2 years, 5 years, 10 years)
- Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with HOOS(pre-op,6 months, 1 year, 2 years, 5 years, 10 years)
- Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with MONA(6 months, 1 year, 2 years, 5 years, 10 years)
- Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with VAS(pre-op,6 months, 1 year, 2 years, 5 years, 10 years)