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Prospective Catalystem CT-RSA

7 de julio de 2026 actualizado por: Canadian Radiostereometric Analysis Network

Multi-center, Non-controlled, Prospective CT-based Radiostereometric Analysis of Catalystem Primary Hip System

Multi-Centre Study in patients undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System. The primary objective is to establish the mean inferior stem migration (subsidence) of the CATALYSTEM™ stem using CT-RSA over the first two postoperative years.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This study is designed as a prospective, multi-center, non-controlled study of subjects implanted with the CATALYSTEM™ Primary Hip System for primary Total Hip Arthroplasty (THA). Subjects will be enrolled and followed for 2 years post-operatively.

Radiostereometric analysis (RSA) is a tool to measure implant migration, originally developed in the 1970s. It is now well-established that early migration (micromotion) of implants with respect to bone is a predictor for later aseptic loosening. Traditional RSA used dual x-ray to estimate implant migration and has been standardized. CT-based methods (CT-RSA), which do not require metal reference beads have been developed since, and have been validated with equivalent results. International guidelines have since been updated to reflect this move to CT-RSA.

The primary objective is to establish the mean inferior stem migration (subsidence) of the CATALYSTEM™ stem using CT-RSA over the first two postoperative years.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

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.

Estudio Contacto

  • Nombre: Sarah Tran
  • Número de teléfono: 204-926-1231
  • Correo electrónico: stran@orthoinno.com

Copia de seguridad de contactos de estudio

  • Nombre: Shalini Hari Kumar
  • Número de teléfono: 204-926-1232
  • Correo electrónico: skumar@orthoinno.com

Ubicaciones de estudio

  • Canadá
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R2K 2M9
        • Orthopaedic Innovation Centre
        • Investigador principal:
          • Thomas Turgeon, MD
        • Sub-Investigador:
          • Eric Bohm, MD
        • Sub-Investigador:
          • Colin Burnell, MD
        • Contacto:
        • Sub-Investigador:
          • Pakpoom Ruangsomboon, MD
        • Sub-Investigador:
          • Bryan Flynn, MD
        • Sub-Investigador:
          • Christopher Graham, MD
        • Sub-Investigador:
          • Elias Saidy, MD

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

Sí

Descripción

Inclusion Criteria:

  1. Patient requires primary unilateral THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital dysplasia.
  2. Patients is at least 21 years old at the time of informed consent.
  3. Patient is able to read and comprehend the informed patient consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information for study purposes.
  4. Patient is able and willing to return for follow-up as specified by the study protocol.
  5. Patient is able and willing to complete the required questionnaires and patient-completed portions of the study protocol.

Exclusion Criteria:

  1. Patient requires implants other than the planned components or would not be a candidate for allowable components to be used (see 4) in the judgement of the surgeon.
  2. Patient is planned to have simultaneous bilateral hip arthroplasty
  3. Patient had contralateral hip arthroplasty less than 6 months prior to the day of surgery.
  4. Patient is expected to have contralateral hip arthroplasty in the following 6 months at the time of consent into this study.
  5. Patient has active local or systemic infection.
  6. Patient has amputations in either leg that would impact rehabilitation following surgery.
  7. Patient has loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery.
  8. Patient has poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis, or require additional fixation, or a significant chance of periprosthetic fracture, or the lack of adequate bone to support the implant(s).
  9. Patient has Charcot's or Paget's disease.
  10. Patient is pregnant or lactating.
  11. Patient is bedridden.
  12. Patient has participated in a clinical investigation with an investigational product (drug or device) in the last 3 months.
  13. Patient is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
  14. Patients is, in the opinion of the surgeon, a drug or alcohol abuser or has psychological disorder(s) that could affect their ability to complete patient-reported questionnaires or be compliant with follow-up requirements.
  15. Patient is diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: CATALYSTEM
CATALYSTEM Hip Replacement System
Dispositivo: CATALISTEMA
Sistema primario de cadera no cementado CATALYSTEM para participantes con artroplastia total de cadera

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Migration - CATALYSTEM Stem
Periodo de tiempo: 2 Years
CT-RSA software (V3MA, Leiden, Netherlands) will be used for the analysis of CT images based on extracted 3-dimensional computer models of the Catalystem stem and surrounding bone from the images to represent the respective rigid bodies.
2 Years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Subsidence - CATALYSTEM Stem
Periodo de tiempo: 6 months and 1 Year
RSA measured subsidence of the CATALYSTEM stem at 6 months and 1 year and to compared to literature values of other stems, using t-test where appropriate.
6 months and 1 Year
Other RSA measurements - CATALYSTEM stem
Periodo de tiempo: 6 Weeks, 6 Months, 1 Year and 2 Years
Other RSA measurements of the Emphasys Stem (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points. These endpoints will be compared to literature values of other stems, using t-test where appropriate.
6 Weeks, 6 Months, 1 Year and 2 Years
Oxford Hip Score
Periodo de tiempo: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living.
Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Forgotten Joint Score (FJS-12)
Periodo de tiempo: 6 Weeks, 6 Months, 1 Year and 2 Years
Functional and health status will be measured with the Forgotten Joint Score (FJS-12). The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily lower degree of joint awareness.
6 Weeks, 6 Months, 1 Year and 2 Years
European Quality of Life (EQ-5D-5L)
Periodo de tiempo: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
EQ5D consists of 5 subscales; Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety / depression. A health state score is obtained based on the responses from 1-5 in each subscale, from which a single index value is calculated representing patients' overall health state. EQ5D includes a so called EQ VAS score which is the patients' self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled "the best health you can imagine" and "the worst health you can imagine".
Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Patient Satisfaction (VAS)
Periodo de tiempo: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Evaluate and compare the change from preoperative to 2 years between the timepoints in patient-reported Satisfaction as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied)
Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Complication
Periodo de tiempo: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Evaluate the type and frequency of the complications/adverse events.
Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Canadian Radiostereometric Analysis Network

Investigadores

  • Investigador principal: Thomas Turgeon, MD, University of Manitoba

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 (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

7 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de julio de 2026

Publicado por primera vez (Actual)

13 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • #5179

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.

Sí

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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