Prospective Randomized Trial of Navigated and Conventional TKA
Prospective Randomized Trial of Navigated and Conventional TKA With Radiographic and CT Evaluations
연구 개요
상세 설명
Component position, kinematics After skin closure lateral x-rays were done in different flexion angles in order to evaluate the kinematic behaviour of the TKA.
A full-length standing and a lateral radiograph as well as CT scans of the hip, knee and ankle joint were performed 5 to 7 days postoperatively before discharge.
- clinical outcome Patient sociodemographic and anamnestic data were collected. The written interview was complemented by the EuroQol questionnaire (release EQ-5D) and the assessment of the patients' functional status (Knee Society Score) one week before surgery and 18 to 24 month after surgery.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Dresden, 독일, 01307
- University Hospital Dresden, Orthopaedic Department
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- primary or secondary osteoarthritis of the knee
- indication to TKA
- a mechanical axis between 20° varus and 5° valgus
- signed informed consent
Exclusion Criteria:
- previous hemi- or total arthroplasty
- severe instability that could not be treated with an unconstrained, cruciate-retaining TKA
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: navigated TKA
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In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases. The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation. The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides.
다른 이름들:
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다른: conventional TKA
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In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases. The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation. The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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rotational component position
기간: postoperatively
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postoperatively
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2차 결과 측정
결과 측정 |
기간 |
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leg axis
기간: postoperatively
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postoperatively
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kinematics
기간: postoperatively
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postoperatively
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clinical outcome
기간: 18 to 24 month postoperatively
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18 to 24 month postoperatively
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공동 작업자 및 조사자
수사관
- 연구 책임자: Klaus-Peter Günther, MD, PhD, Orthopaedic Department, University Hospital Dresden
간행물 및 유용한 링크
일반 간행물
- Lutzner J, Krummenauer F, Wolf C, Gunther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1302/0301-620X.90B8.20553.
- Beyer F, Pape A, Lutzner C, Kirschner S, Lutzner J. Similar outcomes in computer-assisted and conventional total knee arthroplasty: ten-year results of a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 18;22(1):707. doi: 10.1186/s12891-021-04556-3.
- Harman MK, Banks SA, Kirschner S, Lutzner J. Prosthesis alignment affects axial rotation motion after total knee replacement: a prospective in vivo study combining computed tomography and fluoroscopic evaluations. BMC Musculoskelet Disord. 2012 Oct 23;13:206. doi: 10.1186/1471-2474-13-206.
- Lutzner J, Krummenauer F, Gunther KP, Kirschner S. Rotational alignment of the tibial component in total knee arthroplasty is better at the medial third of tibial tuberosity than at the medial border. BMC Musculoskelet Disord. 2010 Mar 25;11:57. doi: 10.1186/1471-2474-11-57.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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