Comparing Outcomes of Labrum Preservation vs Excision in Primary Total Hip Arthroplasty
3. září 2026 aktualizováno: 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.
Přehled studie
Postavení
Zápis na pozvánku
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
200
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Georgia
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Sandy Springs, Georgia, Spojené státy, 30328
- Total Joint Surgery Center Atlanta
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Veterans RAND 12-Item Health Survey (VR-12) Physical Component Score (PCS)
Časové okno: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
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)
Časové okno: 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)
Časové okno: 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)
Časové okno: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Iliopsoas Pain
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
7. července 2026
Primární dokončení (Odhadovaný)
1. července 2027
Dokončení studie (Odhadovaný)
1. července 2028
Termíny zápisu do studia
První předloženo
22. července 2026
První předloženo, které splnilo kritéria kontroly kvality
3. září 2026
První zveřejněno (Aktuální)
10. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
10. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. září 2026
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- NSH1444
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