Comparison of the Oxford Unicompartmental Knee Prosthesis With the Sigma High Performance Partial Knee Using Rontgen Stereophotogrammetric Analysis in Patients With Primary Medial Unicompartmental Knee Osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 主要终点
- Migration of prosthesis
研究概览
简要总结
Comparison of two unicompartmental knee arthroplasties (UKA), to see if Sigma UKA performs equally good as the Oxford UKA. The study focuses on how well the arthroplasty is fixated to the bone and on the difference in wear of the plastic insert. Finally, the functional outcome after surgery is compared between the two arthroplasties.
Hypothesis:
H1: The Sigma UKA has an equal migration pattern compared to the Oxford UKA with a follow up of two years - that is, no significant difference in migration between 1-2 years follow-up.
H2: The Oxford and Sigma UKA's have comparable polyethylene wear with a follow up of 5 years.
H3: The Oxford and Sigma UKA's have comparable patient perceived outcome measures (PROM) and leg extension power (LEP) postoperative.
H4: BMD of the proximal tibia does not influence migration of the tibial component
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All eligable patients with medial osteoarthritis of the knee.
排除标准
- •- Inflammatory arthritis.
- •Patients who are not able to participate in the fast-track surgery program.
- •Patients with a contralateral knee arthroplasty.
- •Patients who are unable to provide informed consent.
- •Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy.
- •Serious systemic disease (e.g.. hemiparesis and severe parkinsonism)
- •On-going case involving work injury of the knee.
- •Female patients with a wish of becoming pregnant in the study period.
研究组 & 干预措施
Oxford
Patients receiving an Oxford UKA, which is the standard treatment for patients with medial osteoarthritis of the knee at our department.
干预措施: Oxford UKA vs Sigma UKA (Other)
Sigma
Patients receiving a Sigma UKA, which is the experimental treatment.
干预措施: Oxford UKA vs Sigma UKA (Other)
结局指标
主要结局
Migration of prosthesis
时间窗: 2 years follow-up
RSA
次要结局
- Bone mineral density(2 years follow-up)
- Polyethylene wear(5 years follow-up)
研究者
Daan Koppens
MD
Regional Hospital Holstebro