Comparing Outcomes of Labrum Preservation vs Excision in Primary Total Hip Arthroplasty
3 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Inscripción por invitación
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Georgia
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Sandy Springs, Georgia, Estados Unidos, 30328
- Total Joint Surgery Center Atlanta
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Veterans RAND 12-Item Health Survey (VR-12) Physical Component Score (PCS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Iliopsoas Pain
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de julio de 2026
Finalización primaria (Estimado)
1 de julio de 2027
Finalización del estudio (Estimado)
1 de julio de 2028
Fechas de registro del estudio
Enviado por primera vez
22 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de septiembre de 2026
Publicado por primera vez (Actual)
10 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- NSH1444
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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