RObotic 보조 대 기존 무릎 관내 인공 삽입물 기술 비교 (ROCKETS)
로켓: 무작위, 다기관, 선호도 관용 연구에서 로봇 보조 대 기존 무릎 관내 인공 삽입물 기술 비교
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Olof Sköldenberg, MD, PhD
- 전화번호: 46+700891253
- 이메일: olof.skoldenberg@ki.se
연구 장소
-
-
-
Hässleholm, 스웨덴, 281 38
- 모병
- Hässleholm Hospital
-
Stockholm, 스웨덴, 182 88
- 모병
- Danderyd Hospital
-
연락하다:
- Olof Skoldenberg, MD, PhD
- 전화번호: +46 8 123 572 45
- 이메일: olof.skoldenberg@ki.se
-
수석 연구원:
- Olof Skoldenberg, MD, PhD
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults aged 18 years and older.
- Eligible for total knee arthroplasty according to local guidelines and routines.
- Willingness to participate in the study.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: RTKR
Robot-assisted total knee arthroplasty (RTKR). |
Robot-assisted total knee arthroplasty using an approved robotic surgical system to assist intraoperative planning, bone preparation, implant positioning and balancing according to the participating centre's approved technique. |
|
활성 비교기: TKR
Conventional total knee arthroplasty (TKR). |
Conventional total knee arthroplasty using standard manual instrumentation according to local clinical routine. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of participants achieving a Forgotten Joint Score (FJS) ≥80 points
기간: 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. |
24 months after surgery
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Forgotten Joint Score (FJS), continuous score
기간: Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
FJS is scored from 0 to 100, with higher scores indicating less awareness of the replaced knee. |
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
|
Knee injury and Osteoarthritis Outcome Score (KOOS)
기간: Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
KOOS assesses knee-related pain, symptoms, activities of daily living, sport/recreation and knee-related quality of life. Each subscale ranges from 0 to 100, with higher scores indicating better outcome. |
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
|
Self-reported knee instability (ADLS items)
기간: Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
Self-reported slipping/partial giving way and buckling/full giving way are assessed using items from the Activities of Daily Living Scale of the Knee Outcome Survey. |
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
|
EQ-5D and EQ VAS
기간: Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
Health-related quality of life is assessed using EQ-5D and EQ VAS. |
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
|
Patient activity and walking distance
기간: Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
Patient activity and walking distance are assessed during follow-up using the study's prespecified activity measurements. |
Baseline, 6 weeks, 12 months, 24 months, 5 years and 10 years after surgery
|
|
Knee alignment
기간: Preoperative and approximately 6 weeks after surgery
|
Coronal knee alignment is assessed using long-standing radiographs, including Hip-Knee-Ankle alignment and Coronal Plane Alignment of the Knee (CPAK) classification. |
Preoperative and approximately 6 weeks after surgery
|
|
Surgery time
기간: During the index operation
|
Duration of the surgical procedure is recorded in minutes. |
During the index operation
|
|
Technical and intraoperative surgical outcomes
기간: During the index operation
|
Technical difficulties and prespecified intraoperative surgical details are recorded. |
During the index operation
|
|
Range of motion (ROM)
기간: 24 months after surgery
|
Knee range of motion is assessed at the 24-month follow-up. |
24 months after surgery
|
|
Reoperations and revisions
기간: Up to 24 months, with additional follow-up at 5 and 10 years
|
Reoperations and revisions of the index knee are recorded during the primary study period and assessed during long-term follow-up where data are available. |
Up to 24 months, with additional follow-up at 5 and 10 years
|
|
Adverse events and complications
기간: Up to 24 months, with additional long-term assessment at 5 and 10 years
|
Adverse events and complications related to the index knee arthroplasty are recorded. Long-term complications may additionally be assessed using approved registry or other data sources. |
Up to 24 months, with additional long-term assessment at 5 and 10 years
|
|
Mortality
기간: 90 days, 1 year, 5 years and 10 years after surgery
|
Mortality is assessed using available approved registry or other data sources. |
90 days, 1 year, 5 years and 10 years after surgery
|
|
Health-economic outcomes
기간: Up to 24 months; exploratory long-term analyses at 5 and 10 years where data are available
|
Health-economic analyses include direct and indirect costs and cost-effectiveness using health-related quality-of-life data. |
Up to 24 months; exploratory long-term analyses at 5 and 10 years where data are available
|
공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2024DS
- Knee (기타 식별자: Danderyds sjukhus)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .