Prospective Catalystem CT-RSA
ConditionHip Osteoarthritis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorCanadian Radiostereometric Analysis Network
About this trial
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.
Eligibility criteria
Qualifiers
Patient requires primary unilateral THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital dysplasia.
Patients is at least 21 years old at the time of informed consent.
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.
Patient is able and willing to return for follow-up as specified by the study protocol.
Disqualifiers
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.
Patient is planned to have simultaneous bilateral hip arthroplasty
Patient had contralateral hip arthroplasty less than 6 months prior to the day of surgery.
Patient is expected to have contralateral hip arthroplasty in the following 6 months at the time of consent into this study.
Trial design
Treatments tested in this trial
- CATALYSTEM
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov