CREST: Capsular Repair During Hip Arthroscopy

Overview

Información sobre este estudio

Capsular REpair randomiSed controlled Trial (CREST) is a multi-center, randomized controlled trial with a sample size of 240 patients (120 patients in each group). The primary outcome measure is functional outcome as measured by the change in Hip Outcome Score at 6 months with secondary outcomes being hip range of motion, i-HOT 12, overall satisfaction, and VAS. Patients are stratified based on gender. Patients, outcome assessors, and data analysts are blinded to surgical allocation. Using an intention-to-treat approach, outcome analyses will be performed using an analysis of covariance and descriptive statistics.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Adults aged 18 to 60 (men or women).
  • Hip pain for greater than 3 months that has failed non-operative treatment (physical therapy, NSAIDS, rest).
  • FAI documented on X-Ray or Magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA).
  • Intraoperative labral repair or intact labrum.
  • Informed consent from the participant.
  • Ability to comprehend and speak English and the study design.

Pre-operative Exclusion Criteria are the following:

  • Hypermobility/Ehlers-Danlos syndrome.
  • Evidence of hip dysplasia (Center edge angle less than 20).
  • Previous surgery or trauma of the affected hip.
  • Severe acetabular deformities such as circumferential labral ossification, acetabular protrusion.
  • Inflammatory/ autoimmune disease.
  • Immunosuppressant medication.
  • Significant medical co-morbidities such as uncontrolled diabetes, hypertension, congestive heart failure, etc.
  • Severe mental or physical disability requiring assistance in daily living.
  • History of pediatric hip disease with previous operation (developmental dysplasia, Legg-Calve-Perthes, Slipped capital femoral epiphysis).
  • Presence of advanced hip osteoarthritis (Tonnis grade 2 or 3).
  • Worker's compensation status.
  • Intraoperative microfracture, or other procedure that would alter postoperative rehabilitation.
  • Intraoperative labral debridement or labral reconstruction.
  • Peri-trochanteric or deep gluteal space arthroscopy.
  • Avascular necrosis.

Intra-operative Exclusion Criteria are the following:

  • Labral debridement.
  • Labral reconstruction.
  • Poor quality capsular tissue.
  • Hyperlaxity based on excessive subluxation of the joint greater than 2 cm with standard 50 pounds of traction.
  • MFX procedures that would change post-op rehabilitation are excluded.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Aaron Krych, M.D.

Cerrado para la inscripción

Contact information:

Jennifer Krogman

(507)538-3562

Krogman.Jennifer@mayo.edu

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Aaron Krych, M.D.

Cerrado para la inscripción

Contact information:

Brynn Goldberg M.S.N., R.N.

(480)342-2762

goldberg.brynn@mayo.edu

More information

Publicaciones

  • The primary objective of this study was to determine whether capsular management technique influences clinical outcomes at a minimum of 2 years after arthroscopic hip preservation surgery. Read More on PubMed
  • Hip capsular management after hip arthroscopic surgery for femoroacetabular impingement (FAI) is controversial. Read More on PubMed
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CLS-20409726

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