- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07600632
Retrospective and Prospective Evaluation of Hip Short Stem Performed by Anterior Approach (AMISP)
Clinical and Radiographic Evaluation of a Short Stem for Primary Hip Replacement Performed by Anterior Approach: A Retrospective and Prospective Study
This study aims to evaluate the clinical, radiographic, and perioperative outcomes of short femoral stems implanted during primary total hip arthroplasty performed through a minimally invasive direct anterior approach (DAA). Short femoral stems have been developed to preserve proximal femoral bone stock, potentially provide a more physiological load transfer, and facilitate implantation through less invasive surgical exposures, particularly in younger and more active patients.
The stem is a cementless hydroxyapatite-coated triple-tapered short stem, has been previously used because its design allows simplified femoral canal preparation and easier implant insertion during minimally invasive anterior approaches, where femoral exposure may be technically demanding. However, previous reports have shown conflicting results regarding implant survivorship and radiographic outcomes, including increased rates of radiolucent lines, pedestal formation, and stem subsidence, particularly among younger and more active patients.
The present study will investigate the technical and clinical implications of using short femoral stems through a minimally invasive anterior approach. Primary outcomes will include perioperative complication rates, wound characteristics, peri-incisional tissue condition, postoperative bleeding, and other surgery-related complications. Secondary outcomes will include postoperative pain, functional recovery, clinical outcome scores, implant survivorship, and serial radiographic findings at short- and mid-term follow-up.
Given the limited evidence currently available regarding the short- and mid-term performance of short femoral stems implanted through the direct anterior approach, this study aims to provide a comprehensive clinical and radiographic evaluation of these implants over time. Adverse events will be continuously monitored through scheduled clinical and radiographic assessments.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Stefano Lucchini, MD
- 전화번호: 0516366961
- 이메일: stefano.lucchini@ior.it
연구 장소
-
-
-
Bologna, 이탈리아, 40136
- 모병
- IRCCS Istituto Ortopedico Rizzoli
-
연락하다:
- Stefano Lucchini, MD
- 전화번호: 0516366961
- 이메일: stefano.lucchini@ior.it
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Diagnosis of primary hip osteoarthritis or osteonecrosis
- Minimally invasive direct anterior approach
- Cementless femoral component
- Minimum follow-up of 2 years
- Patient willingness to participate in the study with written informed consent
- Age over 18 years
- Male or female patients
Exclusion Criteria:
- Other diagnoses of secondary hip osteoarthritis
- Non-anterior surgical approach
- Cemented or other types of components
- Patient unwillingness to participate in the study
- Inadequate clinical and radiological documentation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
patients
Patients undergoing total hip arthroplasty for osteoarthritis through a direct anterior approach with a short femoral stem
|
Total Hip Arthroplasty via Direct Anterior Approach
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Implants survival
기간: at least 5 years after surgery
|
Survival of hip implants at the follow up period (survival meaning implants which were not revised for any cause at the follow up perios)
|
at least 5 years after surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Intra and perioperative complications
기간: On the day of the surgery
|
The Clavien-Dindo score is a system used to classify and standardize postoperative surgical complications according to their severity and the type of treatment required to manage them.
It is widely used in clinical studies and surgical registries because it allows objective comparison of outcomes between different techniques or procedures.
It was originally proposed by Pierre-Alain Clavien and later modified by Daniel Dindo.
|
On the day of the surgery
|
|
radiological outcomen 1
기간: at least 5 years after surgery
|
osteointegration of the stem according to Le Beguec: Classification of osseointegration according to Emmanuel L. L. Le Béguec: bone ingrowth (stable biological fixation), fibrous fixation (stable but non-osseointegrated interface), and unstable fixation (radiographic and/or clinical signs of loosening).
|
at least 5 years after surgery
|
|
radiological outcome 2
기간: at least 5 years after surgery
|
osteointegration of the stem according to Engh: Classification according to Charles A. Engh: stable bone ingrowth fixation (definitive osseointegration), stable fibrous fixation (no progressive loosening despite absence of full bone ingrowth), and unstable fixation (evidence of implant loosening or migration).
|
at least 5 years after surgery
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Garavaglia G, Gonzalez A, Barea C, Peter R, Hoffmeyer P, Lubbeke A, Hannouche D. Short stem total hip arthroplasty with the direct anterior approach demonstrates suboptimal fixation. Int Orthop. 2021 Mar;45(3):575-583. doi: 10.1007/s00264-020-04910-5. Epub 2021 Jan 11.
- Giardina F, Castagnini F, Stea S, Bordini B, Montalti M, Toni A. Short Stems Versus Conventional Stems in Cementless Total Hip Arthroplasty: A Long-Term Registry Study. J Arthroplasty. 2018 Jun;33(6):1794-1799. doi: 10.1016/j.arth.2018.01.005. Epub 2018 Jan 11.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AMISP 277/2025/Oss/IOR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
고관절염에 대한 임상 시험
-
Azienda Unita Sanitaria Locale di PiacenzaUniversity of Parma모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)체코, 이탈리아
Total Hip Arthroplasty에 대한 임상 시험
-
Biomimedica, Inc종료됨
-
Mount Sinai Hospital, Canada알려지지 않은
-
Samsung Medical CenterSamsung Electronics완전한
-
McGill University Health Centre/Research Institute...Canadian Institutes of Health Research (CIHR); Greybox Solutions Inc.완전한
-
University of AarhusAarhus University Hospital; Zimmer Biomet완전한