Comparing Outcomes of Labrum Preservation vs Excision in Primary Total Hip Arthroplasty
2026年9月3日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Georgia
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Sandy Springs、Georgia、アメリカ、30328
- Total Joint Surgery Center Atlanta
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Veterans RAND 12-Item Health Survey (VR-12) Physical Component Score (PCS)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Iliopsoas Pain
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月7日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2028年7月1日
試験登録日
最初に提出
2026年7月22日
QC基準を満たした最初の提出物
2026年9月3日
最初の投稿 (実際)
2026年9月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月10日
QC基準を満たした最後の更新が送信されました
2026年9月3日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- NSH1444
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