- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00604734
A Prospective Clinical Study On A Total Hip Resurfacing System
연구 개요
상세 설명
The study is designed as a prospective, multi-center, non-randomized study. It is designed to evaluate the effects of metal-on-metal acetabular articulating bearing surfaces.
The device will be used in conjunction with a cemented metal femoral resurfacing prosthesis.
The objective of this clinical investigation is to evaluate the safety and effectiveness of the metal-on-metal Recap Total Resurfacing System.
Performance will be assessed trough Harris Hip Score, radiographic evaluation at various postoperative visits. Adverse events and revisions will be documented for safety assessments.
Primary endpoints:
- Total Harris hip score
- Device revisions or removals
Secondary endpoints:
- Total Harris hip score
- Radiographic changes as evidenced by:
I. Acetabular component migration, change in angle of inclination or presence of osteolysis II. Femoral component subsidence, femoral neck Fracture or presence of osteolysis
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Sint Niklaas, 벨기에
- Az Nikolaas Campus Sint Niklaas
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with a preoperative Total Harris Hip Score of < 70
- Conservative treatment has proven unsuccessful
- Primary hip surgery
Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of:
- Osteoarthritis
- Avascular necrosis
- Legg Perthes
- Rheumatoid Arthritis
- Juvenile Rheumatoid Arthritis
- Systemic Lupus Erythematosus
- Developmental Dysplasia, which does not prevent stable acetabular reconstruction
- Post traumatic arthritis S. Patients at least 18 years of age
6. Patients of all races and gender 7. Patients who are able to follow post-operative care instructions 8. Patients who are willing and able to return for scheduled follow-up evaluations 9. Patient has signed the IRB approved Informed Consent Form
Exclusion Criteria:
- Patients with a preoperative Total Harris Hip Score of > 70
- Previous prosthetic hip replacement device (including other surface arthroplasty, endoprosthesis,etc) in the operative hip
- Contralateral hip prosthesis (total hip replacement or surface replacement),including staged or simultaneous procedures
- Developmental dysplasla, which prevents stable acetabular reconstruction
- Patients with previous Girdlestone procedures
- Patients with above knee amputation of the contralateral and/or ipsilateral leg
- Severe osteoarthritis or marked bone loss,which would preclude proper fixation of the prosthetic device(s)
- Active or suspected systemic or localized Infection
- Parkinson's or Alzheimer's Disease
- Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue,which would preclude stability of the prosthesis
- Patients less than 18 years of age
- Patients with condition(s) that may Interfere with the survival of the femoral resurfacing or acetabular replacements or their outcomes,including Paget's Disease, Charcot's Disease, Sickle Cell Anemia or traits Severe osteoporosis compromising bone stock (I.e.Dorr type C bone Lower extremity muscular atrophy Neuromuscular disease
- Patients with a clinical conditions that may limit follow-up,including: immunocompromised conditions, hepatitis, active tuberculosis, neoplastic disease, chronic renal failure, organ transplant recipients, known terminal disease process
- Patients with a "fused"hip
- Patients with metal allergy or hypersensitivity
- Participation in a study of any investigational product (drug or device) within the past 12 months
- Prisoners,known drug or alcohol abuser,or mentally incompetent individuals
- Systemic steroids within 6 months
- Patients with a known malignancy
- Patients who are pregnant
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 요약
ReCap 토탈 힙 재포장 시스템
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이것은 고관절 재포장 시스템입니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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해리스 고관절 점수, 장치 수정/제거, 방사선 평가
기간: 수술 후 2년
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수술 후 2년
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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합병증
기간: 언제든지
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언제든지
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Jo De Schepper, MD, AZ Nikolaas
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 (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. .