A Pragmatic, Multicenter, Patient-Blinded, Preference-Tolerant Randomized Clinical Trial Comparing Ceramic Hip Resurfacing With Total Hip Arthroplasty Using Activity Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Mean Daily Walking Distance Over the Postoperative Period From 3 to 24 Months
研究概览
简要总结
MOVE-HIP is a pragmatic, multicenter randomized clinical trial comparing ceramic hip resurfacing arthroplasty with contemporary total hip arthroplasty in adults with symptomatic hip osteoarthritis who are considered clinically eligible for both procedures. Participants in the randomized cohort are allocated 1:1 to either ceramic hip resurfacing or total hip arthroplasty and are kept blinded to treatment allocation where feasible through the 24-month primary follow-up.
The primary objective is to determine whether ceramic hip resurfacing results in greater objectively measured mean daily walking distance over the postoperative period from 3 to 24 months. Activity is assessed during standardized 7-day wearable monitoring periods at 3, 12, and 24 months. The primary estimand is the adjusted overall between-group difference across these postoperative time points. A parallel observational preference cohort may include otherwise eligible patients who decline randomization; this cohort is analyzed separately and does not contribute to the primary randomized inference.
详细描述
The trial is designed to test whether a contemporary ceramic-on-ceramic hip resurfacing strategy provides a clinically meaningful advantage over modern total hip arthroplasty in real-world physical activity. Randomization is stratified by study site and sex. All participants undergo baseline assessment including patient-reported outcomes, radiographs, clinical data, and 7-day wearable activity monitoring before surgery.
The randomized cohort includes 220 participants, 110 per treatment group. Follow-up is planned at 3 months, 12 months, 24 months, 5 years, and 10 years. Secondary outcomes include walking distance at 24 months, daily step count, patient-reported outcomes, radiographic outcomes, perioperative outcomes, complications, reoperations, revisions, implant survival, and health-economic outcomes. The study is academically led, and the observational preference cohort follows the same assessment schedule but is analyzed separately.
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)
盲法说明
Participant blinding is maintained where feasible until completion of the 24-month primary follow-up. The surgical team is aware of treatment allocation. All participants undergo identical wearable monitoring procedures irrespective of allocation.
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
- •Adults aged 18 years or older.
- •Symptomatic hip osteoarthritis for which primary hip arthroplasty is indicated according to routine clinical practice.
- •Considered suitable for both ceramic hip resurfacing arthroplasty and uncemented total hip arthroplasty by the treating surgeon.
- •Ability and willingness to comply with study procedures, including patient-reported outcome measures, radiographs, registry linkage, and repeated wearable monitoring.
- •Provision of written informed consent.
排除标准
- •Anatomical or pathological conditions that clearly preclude hip resurfacing arthroplasty or total hip arthroplasty, including severe deformity requiring non-standard implants or techniques.
- •Insufficient femoral head or acetabular bone quality, including large or multiple cysts, advanced femoral head necrosis, severe osteopenia, or osteoporosis where this would contraindicate hip resurfacing arthroplasty.
- •Body mass index greater than 40 kg/m^
- •Requirement for specialized implants outside routine study procedures.
- •Medical comorbidity rendering the patient unfit for surgery.
- •Cognitive impairment, severe psychiatric disease, alcohol or substance abuse, language barrier, or other reason judged to prevent informed consent or compliance with follow-up.
- •Inability to complete patient-reported outcome measures or to participate in wearable monitoring.
研究组 & 干预措施
Ceramic Hip Resurfacing Arthroplasty
Participants undergo cementless ceramic-on-ceramic hip resurfacing arthroplasty using the selected study system according to manufacturer instructions, surgeon training requirements, and local surgical routines.
干预措施: Ceramic-on-Ceramic Hip Resurfacing Arthroplasty (Procedure)
Total Hip Arthroplasty
Participants undergo contemporary standard primary total hip arthroplasty using established implants and bearing combinations according to local routine and individual clinical assessment. Cementless fixation is expected in most cases where clinically appropriate.
干预措施: Contemporary Total Hip Arthroplasty (Procedure)
结局指标
主要结局
Mean Daily Walking Distance Over the Postoperative Period From 3 to 24 Months
时间窗: 3, 12, and 24 months after surgery
Mean daily walking distance is assessed during standardized 7-day wearable monitoring periods at each postoperative time point. The primary estimand is the adjusted overall between-group difference in mean daily walking distance across 3, 12, and 24 months, with adjustment for preoperative walking distance and prespecified covariates.
次要结局
- Mean Daily Walking Distance at 24 Months(24 months after surgery)
- Mean Daily Step Count Over the Postoperative Period From 3 to 24 Months(3, 12, and 24 months after surgery)
- Forgotten Joint Score-12 (FJS-12) at 24 Months(24 months after surgery)
- Proportion of Participants With FJS-12 Score of 80 or Higher(24 months after surgery)
- Hip Disability and Osteoarthritis Outcome Score (HOOS) Subscales(24 months after surgery)
- University of California, Los Angeles (UCLA) Activity Score(24 months after surgery)
- High-Activity Arthroplasty Score (HAAS)(24 months after surgery)
- EuroQol 5-Dimension (EQ-5D-5L Index)(24 months after surgery)
- EuroQol Visual Analogue Scale (EQ VAS)(24 months after surgery)
- Radiographic Implant and Hip Biomechanics Outcomes(24 months after surgery)
- Adverse Events and Postoperative Complications(From surgery through 24 months)
- Reoperations and Revisions of the Index Hip(From surgery through 24 months)
- Health-Economic Outcomes(From surgery through 24 months)
- Long-Term Implant Survival(5 and 10 years after surgery)
研究者
Olof Skoldenberg
Professor
Karolinska Institutet