- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04114201
Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation (TKA PSI)
Evaluation of Zimmer® Patient Specific Instrumentation vs. Conventional Instrumentation in Total Knee Arthroplasty Procedures: Clinical and Economic Outcomes
연구 개요
상세 설명
The aim of this study was to compare OR resource use and clinical Outcome after Total Knee Arthroplasty (TKA) using Patient-specific (PSI) or conventional Instrumentation.
For this purpose, economic variables of the surgery (number of instrument trays, setup and cut-sew-time), radiological alignment and patient reported outcomes (VAS Pain Scale, Oxford Knee Score, EQ-5D) were assessed. Cost per QALY (quality-adjusted life year) was assessed using the German DRG reimbursement and the EQ-5D.
A total of 139 TKA with PSI or conventional instrumentation were included in three Centers and were assessed before surgery, as well as 6 weeks, 6 and 12 months postoperatively.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hesse
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Lorsch, Hesse, 독일, 64653
- Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch
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Lower Saxony
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Nienburg, Lower Saxony, 독일, 31582
- Department for Orthopaedic and Trauma Surgery, Helios Kliniken Mittelweser
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Saxony
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Dresden, Saxony, 독일, 01307
- University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Painful, disabled knee joint resulting from osteoarthritis requiring primary TKA
- Informed Consent: Patient has signed a "Patient Informed Consent.
- Able and willing to undergo a preoperative MRI scan (for PSI cases) and full-leg, standing radiographs (all cases)
- Able and willing to follow instructions and complete follow-up
- Patient receiving Zimmer NexGen Solutions CR-Flex (including Gender Solutions)
Exclusion Criteria:
- Patient is skeletally immature
- Active Infection (including septic knee, distant infection, or osteomyelitis)
- Severe hip arthrosis
- Neurological disorders (including, but not limited to Parkinson's disease)
- Prior unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
- Hip or knee ankylosis
- Either rheumatoid or post-traumatic knee arthritis
- Scheduled for simultaneous bilateral TKA
- Indications of intra- and/or extra-articular deformations that would inhibit the use of PSI guides
- Any metal within 150 mm of the joint line for the operative-side knee
- Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination
- An existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study
- A female who is pregnant or lactating
- Current involvement in any personal injury litigation, medical-legal or worker's compensation claims
- Arterial disease or stents that would exclude the use of a tourniquet
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: PSI
Patients received TKA using patient-specific Instrumentation.
|
Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
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활성 비교기: Conventional
Patients received TKA conventional Instrumentation.
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Implantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
OR time
기간: during surgery
|
Operating Room (OR) time: incision to Close in minutes
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during surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
OR resource use: number of instrument trays
기간: during surgery
|
OR Efficiency measured by number of instrument trays used
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during surgery
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OR Setup Time
기간: during surgery
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Operating Room (OR) Setup Time in minutes
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during surgery
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Oxford Knee Score
기간: 1 year after surgery
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clinical outcome measured by the Oxford Knee Scoring System.
The Oxford Knee Score is aggregated to a single score where 0 is the worst and 48 is the best Outcome.
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1 year after surgery
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visual analog scale (VAS)
기간: 1 year after surgery
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patient-reported pain scores as measured by the visual analog scale (VAS), ranging from 0 (worst) to 10 (best).
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1 year after surgery
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device alignment
기간: 1 year after surgery
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device alignment as determined using radiographs (A/P long-standing and lateral films)
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1 year after surgery
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EQ-5D-3L
기간: 1 year after surgery
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patients' health-related Quality of life is measured by the EQ-5D-3L, which aggregates to a single index where 0 is the worst and 1 is the best outcome
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1 year after surgery
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공동 작업자 및 조사자
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. .
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-
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