Hip OsteoarthritisNCT07698717
Prospective Catalystem CT-RSA
A study testing CATALYSTEM in people with Hip Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- CATALYSTEM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Patient is able and willing to complete the required questionnaires and patient-completed portions of the study protocol.
Who cannot join
- 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.
- Patient has active local or systemic infection.
- Patient has amputations in either leg that would impact rehabilitation following surgery.
Show all 15Show fewer
- Patient has loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery.
- 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).
- Patient has Charcot's or Paget's disease.
- Patient is pregnant or lactating.
- Patient is bedridden.
- Patient has participated in a clinical investigation with an investigational product (drug or device) in the last 3 months.
- Patient is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Orthopaedic Innovation Centre
Winnipeg, Manitoba, R2K 2M9
Sarah Tran, 204-926-1231, stran@orthoinno.com
Thomas Turgeon, MD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Hip Osteoarthritis
- Being tested
- CATALYSTEM
- Keywords
- Hip Replacement, CATALYSTEM, CT-RSA
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATALYSTEMDevice
CATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| CATALYSTEM | Other | CATALYSTEM Hip Replacement System Receives: Device: CATALYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Years
Secondary outcomes (7)
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.
Measured: 6 months and 1 Year
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.
Measured: 6 Weeks, 6 Months, 1 Year and 2 Years
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.
Measured: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
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.
Measured: 6 Weeks, 6 Months, 1 Year and 2 Years
European Quality of Life (EQ-5D-5L)
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".
Measured: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Patient Satisfaction (VAS)
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)
Measured: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Complication
Evaluate the type and frequency of the complications/adverse events.
Measured: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Radiostereometric Analysis Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Turgeon, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698717
- Sponsor's protocol ID
- #5179
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Non-controlled, Prospective CT-based Radiostereometric Analysis of Catalystem Primary Hip System
- ClinicalTrials.gov ID
- NCT07698717
- Acronym / sponsor ID
- #5179
- Conditions
- Hip Osteoarthritis
- Keywords
- Hip Replacement, CATALYSTEM, CT-RSA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Canadian Radiostereometric Analysis NetworkUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CATALYSTEM | Other | Device: CATALYSTEMCATALYSTEM Hip Replacement System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Patient is able and willing to complete the required questionnaires and patient-completed portions of the study protocol.
Key exclusion criteria (15 listed)
- 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.
- Patient has active local or systemic infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CATALYSTEMCATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty | Device | CATALYSTEM |
Primary outcome
Migration - CATALYSTEM Stem
Time frame: 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.
7 secondary outcomes
Subsidence - CATALYSTEM Stem
Time frame: 6 months and 1 Year
Other RSA measurements - CATALYSTEM stem
Time frame: 6 Weeks, 6 Months, 1 Year and 2 Years
Oxford Hip Score
Time frame: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Forgotten Joint Score (FJS-12)
Time frame: 6 Weeks, 6 Months, 1 Year and 2 Years
European Quality of Life (EQ-5D-5L)
Time frame: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Patient Satisfaction (VAS)
Time frame: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Complication
Time frame: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Related trials for Hip Osteoarthritis
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
Hip OA
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Turgeon, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CATALYSTEM in people with Hip Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Tran (204-926-1231, stran@orthoinno.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migration - CATALYSTEM Stem (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.