Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty: A Single-Blinded Randomized Controlled Trial Evaluating Implant Migration, Acetabular Liner Wear, and Patient Reported Outcome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA.
研究概览
简要总结
The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •• Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty.
- •Participants must be 18-75 years of age.
- •Participants must be able to speak and understand Danish (or depending on country where patient is enrolled).
- •Participants must be able to give informed consent and be cognitively intact.
- •Participants must be expected to be able to complete all postoperative controls.
- •Participants must not have severe comorbidities, ASA-score ≤ 3.
排除标准
- •Terminal illness.
- •Rheumatoid arthritis.
- •Previous fracture of the hip.
- •Osteonecrosis of the hip.
- •Previous infection of the hip.
- •Severe bony deformity warranting the use of non-standard implants.
- •Metastasis in the periarticular bone or proximal femur.
- •Female patients that are pregnant or planning pregnancy during follow-up period
- •If bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation.
- •Documented osteoporosis with patient in active medical treatment.
- •Comorbidity with altered pain perception (e.g. DM with neuropathy).
- •Participants that develop deep infection in the follow-up period are excluded from the project.
结局指标
主要结局
RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA.
时间窗: 2 year
Radiostereometric analysis, RSA, is an accurate technique for measuring small relative motions from sequential sets of radiographs over time and has been used to measure polyethylene wear and implant migration. Measurements are performed in microns.
次要结局
未报告次要终点
研究者
Kirill Gromov
MD, PhD
Hvidovre University Hospital