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Prospective Catalystem CT-RSA

7. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 2M9
        • Orthopaedic Innovation Centre
        • Hovedetterforsker:
          • Thomas Turgeon, MD
        • Underetterforsker:
          • Eric Bohm, MD
        • Underetterforsker:
          • Colin Burnell, MD
        • Ta kontakt med:
        • Underetterforsker:
          • Pakpoom Ruangsomboon, MD
        • Underetterforsker:
          • Bryan Flynn, MD
        • Underetterforsker:
          • Christopher Graham, MD
        • Underetterforsker:
          • Elias Saidy, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: CATALYSTEM
CATALYSTEM Hip Replacement System
Enhet: KATALYSTEM
CATALYSTEM Cementless Primary Hip System for deltakere med total hofteprotese

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Migration - CATALYSTEM Stem
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Subsidence - CATALYSTEM Stem
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Canadian Radiostereometric Analysis Network

Etterforskere

  • Hovedetterforsker: Thomas Turgeon, MD, University of Manitoba

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

7. juli 2026

Først innsendt som oppfylte QC-kriteriene

7. juli 2026

Først lagt ut (Faktiske)

13. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • #5179

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

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