Comparing Outcomes of Labrum Preservation vs Excision in Primary Total Hip Arthroplasty
3 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Iscrizione su invito
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
200
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Georgia
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Sandy Springs, Georgia, Stati Uniti, 30328
- Total Joint Surgery Center Atlanta
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Veterans RAND 12-Item Health Survey (VR-12) Physical Component Score (PCS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Iliopsoas Pain
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
7 luglio 2026
Completamento primario (Stimato)
1 luglio 2027
Completamento dello studio (Stimato)
1 luglio 2028
Date di iscrizione allo studio
Primo inviato
22 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
3 settembre 2026
Primo Inserito (Effettivo)
10 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- NSH1444
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .