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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CATALYSTEM
DeviceCATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: CATALYSTEMOther 1 intervention
Trial outcomes
Primary outcomes
1
Migration - CATALYSTEM Stem
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.
Time frame
2 YearsSecondary outcomes
1
Subsidence - CATALYSTEM Stem
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.
Time frame
6 months and 1 Year2
Other RSA measurements - CATALYSTEM stem
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.
Time frame
6 Weeks, 6 Months, 1 Year and 2 Years3
Oxford Hip Score
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.
Time frame
Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years4
Forgotten Joint Score (FJS-12)
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.
Time frame
6 Weeks, 6 Months, 1 Year and 2 YearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: