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Prospective Catalystem CT-RSA

7 de julho de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

30

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.

Contato de estudo

Estude backup de contato

Locais de estudo

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

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

Sim

Descrição

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.

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: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: CATALYSTEM
CATALYSTEM Hip Replacement System
Dispositivo: CATALISTEM
Sistema primário de quadril sem cimento CATALYSTEM para participantes com artroplastia total de quadril

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Migration - CATALYSTEM Stem
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Subsidence - CATALYSTEM Stem
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Canadian Radiostereometric Analysis Network

Investigadores

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

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 (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2028

Conclusão do estudo (Estimado)

31 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

7 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de julho de 2026

Primeira postagem (Real)

13 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • #5179

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

Sim

produto fabricado e exportado dos EUA

Sim

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