Comparing Outcomes of Labrum Preservation vs Excision in Primary Total Hip Arthroplasty
2026년 9월 3일 업데이트: Total Joint Specialists
Labral Excision vs Preservation in Primary Total Hip Arthroplasty: A Prospective Randomized Controlled Trial
This research is being done to determine whether removing or preserving the acetabular labrum, a ring of cartilage around the hip socket, during hip replacement surgery affects post-operative outcomes, operative time, or ease of placing the hip implant.
Both techniques (labrum removal and labrum preservation) are commonly performed by surgeons during total hip arthroplasty (THA). However, there is no definitive evidence showing whether one approach is better than the other. The goal of this study is to compare recovery and surgical factors between these two routinely used methods.
연구 개요
연구 유형
중재적
등록 (추정된)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Georgia
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Sandy Springs, Georgia, 미국, 30328
- Total Joint Surgery Center Atlanta
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age ≥ 18 years.
- Indication for primary unilateral total hip arthroplasty for osteoarthritis (Tonnis grade ≥2 or surgeon's standard indication).
- Able to provide informed consent and complete PROMs in English (or validated local language instruments).
Exclusion Criteria:
- Prior ipsilateral hip replacement or resurfacing.
- Active infection or inflammatory arthritis where labral management is judged by the surgeon to be non-standard.
- Severe acetabular bone loss or deformity requiring custom implants or complex reconstruction (Crowe III/IV dysplasia).
- Planned simultaneous bilateral hip arthroplasty.
- Preoperative heterotopic ossification.
- Cognitive impairment preventing consent or completion of PROMs.
- Patients for whom the surgeon believes leaving the labrum would be unsafe (e.g., gross interposed soft tissue preventing any reasonable cup placement without removal)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Group A: Labrum Excision
This group has their labrum excised, with is the standard of care for THA.
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The acetabular labrum will be removed during surgery, prior to final cup placement.
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실험적: Group B: Labrum Preservation
The experimental group to test recovery outcomes from preserving the labrum.
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The acetabular labrum will be left in place during surgery unless it physically prevents proper implant seating, in which case it may be trimmed as necessary.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Veterans RAND 12-Item Health Survey (VR-12) Physical Component Score (PCS)
기간: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
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Change in physical health status measured by the Veterans RAND 12-Item Health Survey (VR-12), Physical Component Score.
Scores range from 0 to 100, with higher scores indicating better physical health status.
Compared between labrum excision and labrum preservation groups.
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Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
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Veterans RAND 12-Item Health Survey (VR-12) Mental Component Score (MCS)
기간: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
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Change in mental health status measured by the Veterans RAND 12-Item Health Survey (VR-12), Mental Component Score.
Scores range from 0 to 100, with higher scores indicating better mental health status.
Compared between labrum excision and labrum preservation groups.
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Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
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Procedure Satisfaction (5-Point Likert Scale)
기간: 12 weeks postoperatively
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Patient-reported satisfaction with the surgical procedure, assessed via a 5-point Likert scale at 12 weeks postoperatively.
Scores range from 1 (Very Dissatisfied) to 5 (Very Satisfied), with higher scores indicating greater satisfaction.
Compared between labrum excision and labrum preservation groups.
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12 weeks postoperatively
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Numeric Pain Rating Scale (NPRS)
기간: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
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Patient-reported pain intensity measured by the Numeric Pain Rating Scale, an 11-point scale ranging from 0 to 10, with higher scores indicating worse (greater) pain.
Compared between labrum excision and labrum preservation groups.
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Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
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HOOS, JR. (Hip Disability and Osteoarthritis Outcome Score for Joint Replacement)
기간: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
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Change in hip-specific patient-reported outcome measured by the Hip disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR.).
Scores range from 0 to 100, with higher scores indicating better hip function and less disability.
Compared between labrum excision and labrum preservation groups.
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Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
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Forgotten Joint Score-12 (FJS-12)
기간: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
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Change in joint awareness during daily activities measured by the Forgotten Joint Score-12 (FJS-12).
Scores range from 0 to 100, with higher scores indicating better outcomes (less awareness of the joint, i.e., the joint is more "forgotten").
Compared between labrum excision and labrum preservation groups.
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Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
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Intraoperative Soft-Tissue/Labral Interference with Cup Position
기간: Intraoperative (at time of surgery)
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Surgeon-judged determination (yes/no) of whether soft tissue or the labrum interfered with acetabular cup positioning during the procedure, compared between groups.
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Intraoperative (at time of surgery)
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Protocol Deviation Rate (Labral Removal in Preservation Arm)
기간: Intraoperative (at time of surgery)
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Incidence of labral removal in patients randomized to the labrum preservation arm, performed per the predefined protocol deviation criteria when needed for safe cup or liner seating.
These cases remain in the intention-to-treat analysis and are also assessed in a per-protocol sensitivity analysis.
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Intraoperative (at time of surgery)
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Operative Time
기간: Intraoperative (at time of surgery)
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Total surgical time in minutes from skin incision to skin closure, recorded from the operative record and compared between labrum excision and labrum preservation groups.
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Intraoperative (at time of surgery)
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Total Fluoroscopy Time
기간: Intraoperative (at time of surgery)
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Total fluoroscopy time recorded during the surgical procedure, compared between labrum excision and labrum preservation groups.
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Intraoperative (at time of surgery)
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Incidence of Supplemental Acetabular Screw Use
기간: Intraoperative (at time of surgery)
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Proportion of patients requiring supplemental acetabular screws for component fixation, compared between labrum excision and labrum preservation groups.
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Intraoperative (at time of surgery)
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Estimated Blood Loss (EBL)
기간: Intraoperative (at time of surgery)
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Estimated intraoperative blood loss, compared between labrum excision and labrum preservation groups.
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Intraoperative (at time of surgery)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Iliopsoas Pain
기간: Within 90 days postoperatively
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Incidence of iliopsoas pain reported within 90 days after surgery, compared between labrum excision and labrum preservation groups.
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Within 90 days postoperatively
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Instability
기간: 90 days and 1 year postoperatively
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Incidence of postoperative hip instability, compared between labrum excision and labrum preservation groups.
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90 days and 1 year postoperatively
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Dislocation
기간: 90 days and 1 year postoperatively
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Incidence of postoperative hip dislocation, compared between labrum excision and labrum preservation groups.
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90 days and 1 year postoperatively
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Periprosthetic Joint Infection (PJI)
기간: 90 days and 1 year postoperatively
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Incidence of periprosthetic joint infection, compared between labrum excision and labrum preservation groups.
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90 days and 1 year postoperatively
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Reoperation
기간: 90 days and 1 year postoperatively
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Incidence of reoperation for any cause, compared between labrum excision and labrum preservation groups.
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90 days and 1 year postoperatively
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All-Cause Revision
기간: 90 days and 1 year postoperatively
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Incidence of revision surgery for any cause, compared between labrum excision and labrum preservation groups.
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90 days and 1 year postoperatively
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Wound Complications
기간: 90 days and 1 year postoperatively
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Incidence of postoperative wound complications, compared between labrum excision and labrum preservation groups.
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90 days and 1 year postoperatively
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Venous Thromboembolism (DVT/PE)
기간: 90 days and 1 year postoperatively
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Incidence of venous thromboembolism, including deep vein thrombosis and pulmonary embolism, compared between labrum excision and labrum preservation groups.
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90 days and 1 year postoperatively
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Readmission
기간: 90 days and 1 year postoperatively
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Incidence of hospital readmission, compared between labrum excision and labrum preservation groups.
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90 days and 1 year postoperatively
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 7일
기본 완료 (추정된)
2027년 7월 1일
연구 완료 (추정된)
2028년 7월 1일
연구 등록 날짜
최초 제출
2026년 7월 22일
QC 기준을 충족하는 최초 제출
2026년 9월 3일
처음 게시됨 (실제)
2026년 9월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 3일
마지막으로 확인됨
2026년 9월 1일
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