Comparing Outcomes of Labrum Preservation vs Excision in Primary Total Hip Arthroplasty
3 de setembro de 2026 atualizado 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.
Visão geral do estudo
Status
Inscrevendo-se por convite
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
200
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Georgia
-
Sandy Springs, Georgia, Estados Unidos, 30328
- Total Joint Surgery Center Atlanta
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Group A: Labrum Excision
This group has their labrum excised, with is the standard of care for THA.
|
The acetabular labrum will be removed during surgery, prior to final cup placement.
|
|
Experimental: Group B: Labrum Preservation
The experimental group to test recovery outcomes from preserving the labrum.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Veterans RAND 12-Item Health Survey (VR-12) Physical Component Score (PCS)
Prazo: 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.
|
Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
|
Veterans RAND 12-Item Health Survey (VR-12) Mental Component Score (MCS)
Prazo: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
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.
|
Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
|
Procedure Satisfaction (5-Point Likert Scale)
Prazo: 12 weeks postoperatively
|
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.
|
12 weeks postoperatively
|
|
Numeric Pain Rating Scale (NPRS)
Prazo: 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.
|
Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
|
HOOS, JR. (Hip Disability and Osteoarthritis Outcome Score for Joint Replacement)
Prazo: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
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.
|
Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
|
Forgotten Joint Score-12 (FJS-12)
Prazo: 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.
|
Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
|
Intraoperative Soft-Tissue/Labral Interference with Cup Position
Prazo: Intraoperative (at time of surgery)
|
Surgeon-judged determination (yes/no) of whether soft tissue or the labrum interfered with acetabular cup positioning during the procedure, compared between groups.
|
Intraoperative (at time of surgery)
|
|
Protocol Deviation Rate (Labral Removal in Preservation Arm)
Prazo: Intraoperative (at time of surgery)
|
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.
|
Intraoperative (at time of surgery)
|
|
Operative Time
Prazo: Intraoperative (at time of surgery)
|
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.
|
Intraoperative (at time of surgery)
|
|
Total Fluoroscopy Time
Prazo: Intraoperative (at time of surgery)
|
Total fluoroscopy time recorded during the surgical procedure, compared between labrum excision and labrum preservation groups.
|
Intraoperative (at time of surgery)
|
|
Incidence of Supplemental Acetabular Screw Use
Prazo: Intraoperative (at time of surgery)
|
Proportion of patients requiring supplemental acetabular screws for component fixation, compared between labrum excision and labrum preservation groups.
|
Intraoperative (at time of surgery)
|
|
Estimated Blood Loss (EBL)
Prazo: Intraoperative (at time of surgery)
|
Estimated intraoperative blood loss, compared between labrum excision and labrum preservation groups.
|
Intraoperative (at time of surgery)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Iliopsoas Pain
Prazo: Within 90 days postoperatively
|
Incidence of iliopsoas pain reported within 90 days after surgery, compared between labrum excision and labrum preservation groups.
|
Within 90 days postoperatively
|
|
Instability
Prazo: 90 days and 1 year postoperatively
|
Incidence of postoperative hip instability, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Dislocation
Prazo: 90 days and 1 year postoperatively
|
Incidence of postoperative hip dislocation, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Periprosthetic Joint Infection (PJI)
Prazo: 90 days and 1 year postoperatively
|
Incidence of periprosthetic joint infection, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Reoperation
Prazo: 90 days and 1 year postoperatively
|
Incidence of reoperation for any cause, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
All-Cause Revision
Prazo: 90 days and 1 year postoperatively
|
Incidence of revision surgery for any cause, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Wound Complications
Prazo: 90 days and 1 year postoperatively
|
Incidence of postoperative wound complications, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Venous Thromboembolism (DVT/PE)
Prazo: 90 days and 1 year postoperatively
|
Incidence of venous thromboembolism, including deep vein thrombosis and pulmonary embolism, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Readmission
Prazo: 90 days and 1 year postoperatively
|
Incidence of hospital readmission, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de julho de 2026
Conclusão Primária (Estimado)
1 de julho de 2027
Conclusão do estudo (Estimado)
1 de julho de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
22 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de setembro de 2026
Primeira postagem (Real)
10 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- NSH1444
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .