- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05038670
Journey II vs Persona Knee Systems - RCT
Comparison of Patients-reported Outcome After Total Knee Arthroplasty With Use of Bi-cruciate Stabilized and Personalized Implant Design - Randomized Controlled Trial
연구 개요
상세 설명
The aim of this study is to assess patient-reported outcome, survivorship and radiological analysis in patients after total knee arthroplasty, who will undergo the surgery with the use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith&Nephew Journey II Bi-Cruciate Stabilized (BCS) system.
To this study 45 consecutive patients undergoing total knee arthroplasty will be recruited to each group. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization [1:1]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.
Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity, WOMAC and KOOS scales.
1-day posteoperatively patients will undergo standard computed tomography examination to assess components placement
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Mazovia
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Warsaw, Mazovia, 폴란드, 04-749
- Department of Othopedics and Rehabilitation, Medical University of Warsaw
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw
- Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
- Aged 18 or over
- Patient willing to provide full informed consent to the trial
Exclusion Criteria:
- Listed for a single-stage bilateral TKR procedure
- Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
- Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
- Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
- Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
- Inflammatory arthritis
- Previous septic arthritis in the affected knee joint
- Previous surgery to the collateral ligaments of the affected knee
- Patients on warfarin or novel oral anticoagulants (NOACs)
- Will not be resident in the catchment area for at least 6 months post-surgery
- Undertaking the surgery as a private patient
- Patients who, in the opinion of the clinical staff, do not have capacity to consent
- Patients who are pregnant
- Unable to understand written and spoken Polish
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: PERSONA
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system
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Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
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활성 비교기: Journey II
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith&Nephew Journey II system
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Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score)
기간: baseline (preoperatively) and 1 year postoperatively
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To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis.
Results range from 0 to 100, with higher scores corresponding to better outcomes.
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baseline (preoperatively) and 1 year postoperatively
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Changes in patients reported outcome measures - WOMAC Score (Knee injury and Osteoarthritis Outcome Score)
기간: baseline (preoperatively) and 1 year postoperatively
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To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis.
Results range from 0 to 96, with higher scores corresponding to worse outcomes.
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baseline (preoperatively) and 1 year postoperatively
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Values of components rotation
기간: 1-day postoperatively
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Values of external or internal rotation of components measured in computed tomography postoperatively.
Values in degrees in regards to anatomic bone landmarks
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1-day postoperatively
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공동 작업자 및 조사자
수사관
- 수석 연구원: Artur Stolaerczyk, MD, PhD, Department of Orthopedics and Rehabilitation, Medical University of Warsaw
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
Total Knee Replacement에 대한 임상 시험
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Johnson & Johnson Medical (Suzhou) Ltd.완전한
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Biomimedica, Inc종료됨
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Smith & Nephew, Inc.Nor Consult완전한
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Stryker Orthopaedics완전한
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Smith & Nephew, Inc.완전한Journey II BCS 토탈 무릎 시스템미국, 벨기에, 뉴질랜드
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Stryker South Pacific아직 모집하지 않음
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Zimmer Biomet모집하지 않고 적극적으로류마티스 관절염 | 무릎 통증 | 만성 골관절염 | 대퇴과의 무혈성 괴사 | 중등도의 내반, 외반 또는 굴곡 기형벨기에, 스위스, 독일, 이스라엘, 이탈리아