Early Stability Assessment of the REDAPT Revision Hip System With Radiostereometric Analysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year
研究概览
简要总结
The principal objectives of the study are to evaluate early and mid-term fixation of the REDAPT revision hip stem and acetabular cup as measured by stem subsidence and proximal cup migration at 2 and 5 years post-surgery through model-based RSA. Secondary objectives include; evaluate the progression of migration between 1 and 2 years and between 2 and 5 years, assess pre- to post-surgery patient improvement in function and health status, evaluate femoral and acetabular radiolucency at 2 and 5 years, and assess patterns of stem migrate on for different revision scenarios (preservation of the trochanters and extended trochanteric osteotomy).
详细描述
This is a prospective, single arm, consecutive series study of patients undergoing revision hip arthroplasty. Patients will be grouped based on the revision implants they receive during surgery. Patients who receive a full hip revision (stem and cup), will be counted in both study groups. The two study groups are:
- femoral stem revision (n=30 hips)
- acetabular cup revision (n=22 hips)
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients needing revision hip arthroplasty in which either the femoral stem or the acetabular cup, or both components, will be revised
- •Ability to use study device (not requiring specialized implants)
- •Patients between the ages of 18+ older
- •Patients willing and able to comply with follow-up requirements and self-evaluations
- •Ability to give informed consent
排除标准
- •Acute infection requiring washout, debridement, and liner exchange
- •Unresolved infection
- •Undergoing stage 1 of a 2-stage revision for infection
- •Known metal allergy to device components
- •Active participation in another clinical study (within the past 30 days)
- •Known risk for loss to follow-up (significant geographical distance from treatment centre)
- •BMI>40 (severe obesity)
- •Unable to provide informed consent (cognitive impairment)
- •Patients requiring a bearing couple different than metal on polyethylene
- •Patients requiring extreme distal press-fit revision stems (greater than 240 mm in length)
- •Patients with severe defects, dysplasia, or tumor
- •Inflammatory joint disease
结局指标
主要结局
Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year
时间窗: Pre-op, Post-op (6 months, 1 year, and 2 years)
The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living.
Changes in Patient Satisfaction (Likert scale) from baseline(pre-op) to 6-month, 1-year and 2-year
时间窗: Pre-op, Post-op (6 months, 1 year, and 2 years)
Patient satisfaction with their hip surgery will be assessed using a 5-point Likert scale: Very Unsatisfied (1), Unsatisfied (2), Neutral (3), Satisfied (4), and Very Satisfied (5).
Change is Pain VAS from baseline(pre-op) to 6-month, 1-year and 2-year
时间窗: Pre-op, Post-op (6 months, 1 year, and 2 years)
Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)
Changes in RSA Migrations from baseline(2-week) to 6-month, 1-year and 2-year
时间窗: Post-op: 2-week, 6-month, 1-year, 2-year
Stability over a period of two year measured by migration with Röntgen Stereometric Analysis
Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year
时间窗: Pre-op, Post-op (6 months, 1 year, and 2 years)
The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
次要结局
- Stem subsidence(1-year, 2-year)