- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07608237
Labral Repair vs Reconstruction
Labral Repair Versus Reconstruction in Symptomatic Femoroacetabular Impingement in Patients Over 40 Years of Age - A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Femoroacetabular impingement syndrome (FAIS) is an increasingly common cause hip pain. It is known to cause labral pathology and if left untreated, can also contribute to the development of hip osteoarthritis. While non-operative treatment has been shown to be effective and can improve patients' quality of life, surgical treatment has often been shown to yield superior outcomes, while also potentially decreasing the future risk of osteoarthritis.
Mid- to long-term outcomes have shown durable results following hip arthroscopy with significant improvements in patient reported outcome measures (PROMs). Consequently, hip arthroscopy utilization has continued to increase. Several retrospective cohort studies have attempted to identify prognostic variables associated with procedural outcomes. In terms of patient selection, age has historically been identified as a negative prognostic variable, with inferior clinical outcomes observed in patients over the age of 40. However, more recent studies have disputed this finding, suggesting that earlier studies reporting this included patients with concomitant hip osteoarthritis, which was more to blame than their chronological age. Recent case series have reported significant improvements in PROMs in patients over the age of 40 who have minimal concomitant OA (Tönnis 0 or 1), with durable results out to 5 years14-16.
Despite these encouraging results, newer concerns have been raised when it comes to labral treatment in this demographic. It has been suggested that in patients over 40 years of age, the labrum may be too traumatized to allow repair or that it may have diminished healing capacity from repetitive impingement or age-related degeneration. As such, there have been proponents of performing a primary labral reconstruction in this patient population, with better associated outcomes. Others have reported equivocal outcomes between repair and reconstruction for this group. As such, there is no consensus on the best treatment strategy to manage these patients.
The results of this pilot study will allow the investigators to determine whether a full-scale study will be feasible. The investigators will not move forward with the full study: 1) if the proportion of eligible patients providing consent is <80%; 2) If the 95% confidence intervals around the difference between groups does not include even the possibility of a small, but important effect (0.2 SD); 3) if the proportion of patients completing their one-year follow-up is <85%, then the study is not feasible.
Ultimately, for the full-scale study, the investigators hypothesize that patients treated with labral reconstruction will have significantly better outcome scores compared with patients who underwent a traditional labral repair. If the hypothesized findings are true in the full study, this will change clinical practice patterns by providing objective evidence to guide treatment of labral pathology in patients over the age of 40 undergoing hip arthroscopy for FAIS.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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London, Ontario, Canadá, N6A 3K7
- Fowler Kennedy Sport Medicine Clinic
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Contacto:
- Ashley Ambrose
- Número de teléfono: 87528 5196612111
- Correo electrónico: ashley.ambrose@lhsc.on.ca
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Investigador principal:
- Ryan Degen
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion:
-Cam or pincer morphology who have failed a trial of conservative treatment
Exclusion:
- Moderate concomitant OA (Tönnis 2+)
- Have had previous hip surgery
- Active joint or systemic infection
- Significant muscle paralysis
- Inflammatory arthropathies
- Significant medical comorbidity that may alter effectiveness of surgical intervention
- Active smoker
- Major medical illness
- Unable to speak and understand English
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for 2 years
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Labral Repair
Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
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Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
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Comparador activo: Labral Reconstruction
Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
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Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
International Hip Outcome Tool (iHOT) - 12
Periodo de tiempo: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Hip Outcome Score- Activities of Daily Living (HOS-ADL)
Periodo de tiempo: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
|
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Hip Outcome Score- Sport Specific Subscale (HOS-SSS)
Periodo de tiempo: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
|
|
modified Harris Hip Score (mHHS)
Periodo de tiempo: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
|
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EQ-5D
Periodo de tiempo: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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Cost Diary
Periodo de tiempo: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Patient Satisfaction Scale
Periodo de tiempo: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Post-operative complication rates
Periodo de tiempo: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
|
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Subsequent surgery rates
Periodo de tiempo: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 127777
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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