ROCKETS: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques in a Randomized, Multicenter, Preference-tolerant Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- Proportion of participants achieving a Forgotten Joint Score (FJS) ≥80 points
研究概览
简要总结
Rationale for conducting the study:
The ROCKET study evaluates the clinical and economic outcomes of robot-assisted total knee arthroplasty (RTKR) compared with conventional total knee arthroplasty (TKR). The primary endpoint is the proportion of randomized participants achieving a Forgotten Joint Score (FJS) of ≥80 points at 24 months after surgery. Secondary outcomes include patient-reported knee function, health-related quality of life, self-reported instability, physical activity, radiographic alignment, surgical and technical outcomes, complications, reoperations, revisions, and health-economic outcomes.
Study design:
International multicentre, preference-tolerant, randomized, controlled superiority trial with two treatment arms comparing RTKR with conventional TKR. Participants in the randomized part are allocated 1:1. At selected centres where feasible, an optional participant-blinded randomized component may be implemented. Eligible patients who do not undergo randomization may participate in a parallel observational/preference cohort, which is analysed separately from the primary randomized comparison.
Study population:
Adults aged 18 years and older who are eligible for total knee arthroplasty according to local guidelines and who provide informed consent.
Number of patients:
Up to 1,600 randomized participants. Eligible non-randomized participants may additionally be included in the observational/preference cohort.
Primary outcome:
Proportion of randomized participants achieving FJS ≥80 points at 24 months after surgery.
Long-term follow-up:
Patient-reported and registry-based outcomes are planned at 5 and 10 years after surgery where feasible.
详细描述
The ROCKET study is an international multicentre, prospective, preference-tolerant randomized controlled superiority trial comparing robot-assisted total knee arthroplasty with conventional total knee arthroplasty.
Participants in the randomized component are allocated 1:1 to robot-assisted or conventional total knee arthroplasty. Randomization is stratified by participating centre and sex. At selected centres where practical and approved, participants may remain blinded to treatment allocation until completion of the 24-month follow-up unless earlier unblinding is clinically required or requested by the participant. Surgeons and operating-room personnel cannot be blinded. Outcome assessment is performed blinded to treatment allocation whenever feasible.
Eligible patients who are unwilling to undergo randomization, or for whom treatment equipoise cannot be achieved, may enter a parallel observational/preference cohort. Treatment in this cohort follows patient and surgeon preference. The observational/preference cohort is analysed separately from the primary randomized comparison.
The primary endpoint is the proportion of randomized participants achieving a Forgotten Joint Score (FJS) of ≥80 points at 24 months after surgery. Follow-up includes patient-reported outcomes, activity, radiographic alignment, surgical and technical variables, complications, reoperations, revisions and health-economic outcomes. Long-term follow-up is planned at 5 and 10 years after surgery, including PROMs where available and registry-based outcomes such as reoperations, revisions, complications and mortality.
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 (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to treatment allocation whenever feasible. At selected participating centres, an optional participant-blinded randomized component is implemented: randomized participants are not informed of their allocated surgical method until after the 24-month follow-up unless unblinding is clinically required or requested by the participant. Surgeons and operating-room personnel cannot be blinded.
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 and older.
- •Eligible for total knee arthroplasty according to local guidelines and routines.
- •Willingness to participate in the study.
排除标准
- •Patients with extreme malalignment necessitating special implants or techniques.
- •Patients unfit for surgery due to other medical reasons.
- •Patients who, for other reasons such as alcohol or substance abuse, are deemed unsuitable to participate in the study.
- •Patients who, for other reasons, cannot fulfil the required patient-reported outcome measures.
研究组 & 干预措施
TKR
Conventional total knee arthroplasty (TKR).
干预措施: Conventional total knee arthroplasty (Procedure)
RTKR
Robot-assisted total knee arthroplasty (RTKR).
干预措施: Robot-assisted total knee arthroplasty (Procedure)
结局指标
主要结局
Proportion of participants achieving a Forgotten Joint Score (FJS) ≥80 points
时间窗: 24 months after surgery
The primary endpoint is the proportion of randomized participants achieving an FJS of ≥80 points at 24 months after surgery. The FJS ranges from 0 to 100, with higher scores indicating less awareness of the replaced knee during everyday activities.
次要结局
- Forgotten Joint Score (FJS), continuous score(Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery)
- Self-reported knee instability (ADLS items)(Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery)
- EQ-5D and EQ VAS(Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery)
- Patient activity and walking distance(Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery)
- Knee alignment(Preoperative and approximately 6 weeks after surgery)
- Surgery time(During the index operation)
- Technical and intraoperative surgical outcomes(During the index operation)
- Range of motion (ROM)(24 months after surgery)
- Reoperations and revisions(Up to 24 months, with additional follow-up at 5 and 10 years)
- Adverse events and complications(Up to 24 months, with additional long-term assessment at 5 and 10 years)
- Mortality(90 days, 1 year, 5 years and 10 years after surgery)
- Health-economic outcomes(Up to 24 months; exploratory long-term analyses at 5 and 10 years where data are available)
研究者
Olof Skoldenberg
Professor
Danderyd Hospital