- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05686915
세라믹 대퇴골두와 티타늄 슬리브를 사용한 수정 THA의 MARS MRI
세라믹 대퇴골두와 티타늄 슬리브를 이용한 인공 고관절 재치환술의 금속 인공물 감소 시퀀스 MRI
Revision total hip replacement using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in individuals doing well after a revision total hip replacement and ceramic bearing surface that utilizes a titanium sleeve.
연구 개요
상태
상세 설명
Metal-on-metal total hip arthroplasty (THA) were heralded as a solution for two of the most common problems in hip arthroplasty in the last decade, instability and osteolysis. Unfortunately, their failures have led to diminished enthusiasm for this bearing surface. Adverse local tissue reactions (ATLRs) have been well documented as a means of pain and failure in this population. A recent report revealed that the most commonly used bearing surface in total hip arthroplasty, metal-on-polyethylene, may have up to a 28% incidence of MRI abnormalities in asymptomatic hips. Revision THA using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in asymptomatic individuals after a revision THA and ceramic bearing surface that utilizes a titanium sleeve. To our knowledge, this has not been studied previously and may provide important baseline features of this diagnostic tool with this particular bearing surface. We hypothesize that there will be fluid collections in a small but clinically significant portion of asymptomatic patients.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Colorado
-
Denver, Colorado, 미국, 80210
- Colorado Joint Replacement
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
설명
Inclusion Criteria:
- Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
- Patient whose age ranges from 18-99
- Patients who are not experiencing groin pain, thigh pain, or pain with ROM of the hip
- Patients who are at least 2 years after a revision THA
- Acetabular implant (cup) was placed in the appropriate position
- Patients with a Harris Hip Score of >90
Exclusion Criteria:
- Patients who do not meet the above criteria
- Patients unable to have an MRI (i.e. pacemaker, metal implants or issues with claustrophobia requiring sedation)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Revision Total Hip Arthroplasty
Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve |
metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities Labs to look at titanium levels in blood Labs to look at cobalt levels in blood Labs to look at chromium levels in blood |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
MARS MRI abnormalities
기간: 2 Years Post Revision Total Hip Replacement
|
Local Tissue Reactions or Fluid collections on the MARS MRI Scan |
2 Years Post Revision Total Hip Replacement
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Titanium Lab Value
기간: 2 Years Post Revision Total Hip Replacement
|
Titanium levels in blood |
2 Years Post Revision Total Hip Replacement
|
|
Chromium Lab Value
기간: 2 Years Post Revision Total Hip Replacement
|
Chromium levels in blood |
2 Years Post Revision Total Hip Replacement
|
|
Cobalt Lab Value
기간: 2 Years Post Revision Total Hip Replacement
|
Cobalt levels in blood |
2 Years Post Revision Total Hip Replacement
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jason M Jennings, MD, Colorado Joint Replacement
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
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. .