비만 환자에서 슬관절 전치환술 시행 시 얻은 정렬에 내비게이션 사용이 미치는 영향 원문보기 KCI 원문보기 인용
NAOBE is a randomized, open and prospective clinical trial that evaluates the accuracy to achieve an adequate mechanical axis of the lower extremity in obese patients after total knee replacement.
연구 개요
상태
상세 설명
Randomized, open and prospective clinical trial.
Following the surgical indication for a total knee replacement as treatment for symptomatic osteoarthritis and the confirmation of obesity (BMI equal or greater than 30 Kg/m2 ), patients will be randomly assigned (ratio 1:1) to one of the following treatments:
Control group: Total knee arthroplasty implanted with standard guides . Experimental group: Total knee arthroplasty(TKA) implanted with GPS navigation system Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.
After the surgery, patients will be followed-up at 6 weeks, 3, 6 and 12 months. At those times, data regarding physical and radiological examinations, pain and functionality and health status questionnaires will be collected.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Madrid
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Madrid, Madrid, 스페인, 28009
- Hospital Universitario Santa Cristina
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Majadahonda, Madrid, 스페인, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and women over 18 years old.
- Written informed consent according to ICH / GCP and Spanish legislation, obtained before any study procedure.
- Patient with a BMI equal to or greater than 30 Kg / m2
- Patients with clinical and radiological criteria of knee osteoarthritis.
- Patients with indication for primary TKA according to medical criteria.
Exclusion Criteria:
- Pregnancy or lactation.
- Inability to give informed consent in the absence of a legal representative.
- Subjects that are participating in a study with medicines or other medical devices.
- Those who show inability to follow the instructions or collaborate during the development of the study.
- If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could have a negative influence
- Having had a previous surgical procedure on or around the knee in the last 12 months (such as proximal tibial osteotomy, femoral osteotomy, open reduction and internal fixation for a fracture, patellectomy or patellar realignment).
- Need a simultaneous bilateral TKA.
- Have a varus angle or valgus ≥ 15 °.
- Total revision knee arthroplasty.
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 |
|---|---|
|
실험적: Experimental
Total knee arthroplasty implanted with GPS navigation system. |
Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment |
|
활성 비교기: Control
Total knee arthroplasty implanted with standard guides. |
Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Deviation in a mechanical axis of knees
기간: 12 months
|
Proportion of knees after surgery with a mechanical axis with a deviation greater than 3º |
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Radiological axes (femoral)
기간: 12 months
|
Position angle of the femoral component: angle formed between the anatomical axis of the femur and the articular surface of the femoral component of the TKA (α). |
12 months
|
|
Radiological axes (tibial)
기간: 12 months
|
Position angle of the tibial component: angle formed between the anatomical axis of the tibia and the proximal surface of the tibial component of the TKA (β). |
12 months
|
|
Surgical procedure time
기간: Week 1
|
Surgical time |
Week 1
|
|
Admission (hospital) duration
기간: Week 1
|
Number of days of the hospital admission |
Week 1
|
|
Number of Surgical complications (Intraoperative)
기간: Week 1
|
Intraoperative complications |
Week 1
|
|
Number of Surgical complications (perioperative)
기간: 1 to 6 weeks
|
perioperative complications |
1 to 6 weeks
|
|
Number of Surgical complications (post-operative)
기간: 1-12 months
|
postoperative complications |
1-12 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Knee Society Score Questionaire
기간: 6 weeks-12 months
|
KSS Questionaire, developed by the Knee Society, assesses the function of the knee replacement and the functional capabilities of patients after their implantation. It has to separate sections ("Knee Score" and "Functional Score") that are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. |
6 weeks-12 months
|
|
Range of Motion
기간: 6 weeks-12 months
|
The maximum extension and flexion |
6 weeks-12 months
|
|
Visual Analogic Scale for pain
기간: 1-12 months
|
VAS measure the intensity of the pain that the patient describes. It consists of a horizontal line of 10 centimeters, with 0cm being "no pain" and 10cm being "extreme pain". |
1-12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Pedro José Torrijos Garrido, MD, PhD, Hospital Universitario Puerta de Hierro
간행물 및 유용한 링크
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
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