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Total Hip Arthroplasty (THA)CATALYSTEMNCT06564636

A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System

An observational study of Total Hip Arthroplasty (THA) and Osteoarthritis, run by Smith & Nephew, Inc. at 10 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A Multi-Center Study in Patients Undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System. The purpose of the study is to assess safety and performance of the CATALYSTEM™ and to support product approval in global markets. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
CATALYSTEM
Type of treatment
Medical device
How many people
119 participants
Where
10 sitesin 2 countries
Study dates
26 Sep 2024to Mar 2036
Phase
Observational
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants who meet the inclusion and exclusion criteria at participating sites in both the United States and Canada.

Who may be able to join

  • a. Subject needing primary THA due to end stage degenerative joint disease (primary diagnosis of osteoarthritis), avascular necrosis, post-traumatic arthritis, inflammatory arthritis, or congenital hip dysplasia and, as part of standard of care, the surgeon determines that surgical treatment with the CATALYSTEM™ is the recommended implant for the subject.
  • OR
  • b. Subject has undergone primary THA with the S+N CATALYSTEM™ Primary Hip stem in the past 12 months for end stage degenerative joint disease (primary diagnosis of osteoarthritis), avascular necrosis, post-traumatic arthritis, inflammatory arthritis, or congenital hip dysplasia and all the following conditions have been met for the appropriate timepoint:
  • Preoperative Patient Reported Outcome Measures (PROMs):
  • Hip Disability and Osteoarthritis Outcome Score Junior (HOOS, JR.)
  • European Quality of Life (EuroQol) Five-dimensional Five-level (EQ-5D-5L), and
Show all 40Show fewer
  • Radiographs have been obtained:
  • ° Anterior Posterior (AP) Pelvis
  • AP Hip*, and
  • Lateral**
  • 6-Weeks
  • ° PROMs (HOOS, JR., and EQ-5D-5L), and
  • Radiographs (AP Pelvis, AP Hip*, and Lateral**) have been obtained or these can be collected prospectively in window per schedule of events, and
  • 1-Year
  • ° PROMs (HOOS, JR., and EQ-5D-5L), and
  • ° Radiographs (AP Pelvis, AP Hip, and Lateral) have been obtained or these can be collected prospectively in window per schedule of events
  • 2. Subject agrees to consent and to follow the prospective study visit schedule by signing the Independent Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF).
  • 3. Subject is eighteen to eighty (18-80) years old (inclusive).
  • 4. Subject can read, understand, and communicate responses to the PROMs.
  • footnote:
  • For the AP radiographs, Standing AP is preferred. For standardization, sites MUST ensure that positioning (standing AP or supine AP) is consistent across all study visits for subjects (i.e., if subject had standing AP at pre-op then collect standing AP at all visits).
  • Frog-lateral is preferred. However, lateral radiograph may include any one of the following: Cross-Table Lateral (CTL) or Frog-lateral or lateral femoral/Lauenstein. For standardization, sites MUST ensure consistency across all study visits for subjects (i.e., if subject had frog-leg lateral at pre-op then collect frog-leg lateral at all visits).
  • Exclusion Criteria: Any one (1) of the following criteria will disqualify a potential subject from participation in the study:
  • Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
  • Blood supply limitations
  • Insufficient quantity or quality of bone support e.g., osteoporosis, or metabolic disorders which may impair bone formation, and or osteomalacia
  • Mental or neurological conditions which may tend to impair the patient's ability or willingness to restrict activities; or impairing or precluding cooperation with post-operative protocols including mental illness, drug or alcohol abuse.
  • Physical conditions or activities which tend to place extreme loads on implants and may impair short and long-term satisfactory results of the implant, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc.
  • Infections or other conditions which may lead to increased bone resorption
  • Skeletal immaturity
  • Subject has a Body Mass Index (BMI) >/= 45 at time of surgery.
  • Subject has a known allergy to one or more components of the study device.
  • Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).
  • Subject is entered in another drug, biologic, or device study or has been treated with an investigational product 30 days prior to the surgery date.
  • Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
  • Women who are pregnant or nursing.
  • Subject has participated previously in this clinical trial and has been withdrawn.
  • Subject has an active infection - systemic or at the site of intended surgery.
  • Subject had a contralateral (opposite) hip replacement that was implanted less than 3 months prior to consent, is scheduled for a simultaneous contralateral hip implant, or plans to have their contralateral hip implanted within 3 months following this study-specific implant (known as 'staged bilateral THA').
  • Subject with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Who cannot join

None listed.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States6 sites

  • Illinois Bone and Joint Institute

    Des Plaines, Illinois, 60016

  • Connecticut Orthopaedic Institute

    Hamden, Connecticut, 06518

  • Duke Health

    Morrisville, North Carolina, 27560

  • NYU Langone Health Orthopedic Hospital

    New York, New York, 10003

  • Orlando Health Inc.

    Orlando, Florida, 32806

  • University of California at San Francisco

    San Francisco, California, 94158

Other trials in United States

Canada4 sites

  • University of Alberta

    Edmonton, Alberta, T6G 2B7

  • London Health Sciences Centre (LHSC)

    London, Ontario, N6A 5A5

  • University of British Columbia

    Vancouver, British Columbia, V5Z 1M9

  • Concordia General Hospital

    Winnipeg, Manitoba, R2K 2M9

Other trials in Canada

About this study

A Multi-Center Study in Patients Undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System. The purpose of the study is to assess safety and performance of the CATALYSTEM™ and to support product approval in global markets.

Read the detailed description

This study is a multi-center, prospective, non-randomized study of subjects implanted with the CATALYSTEM™ Primary Hip System for primary Total Hip Arthroplasty (THA). Subjects will be enrolled and followed for 10 years post-operatively to assess safety and efficacy of the CATALYSTEM™ Primary Hip System. The primary objective is to assess 2-year post-operative stem survivorship of the Collared CATALYSTEM™ Hip System femoral stem with standard or high offset in primary THA procedures. Stem survivorship is defined as no aseptic revision (i.e., revision for any reason except infection) of the implanted femoral stem.

Being tested
CATALYSTEM
Keywords
Total Hip Arthroplasty, THA, Hip System, Hip, CATALYSTEM, CATALYST, Collared, Collarless, Cementless, Primary THA
Medical subject headings
Osteoarthritis, Joint Diseases, Arthritis, Osteonecrosis, Hip Dislocation, Congenital

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 groups in NCT06564636
Study groupRoleWhat they receive
CATALYSTEMParticipants who have already received or are due to receive the CATALYSTEM Cementless Primary Hip System
Receives: Device: CATALYSTEM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Collared CATALYSTEM™ femoral stem implant survivorship 2 years post-operatively

    Stem survivorship is defined as no aseptic revision of the implanted femoral stem

    Measured: 2 years post-operative

Secondary outcomes (4)

  1. Collared CATALYSTEM™ femoral stem implant survivorship rates

    Implant survivorship is defined as no aseptic stem revision

    Measured: 6 weeks, 1 year, 3 years, 5 years, 7 years and 10 years post-operative

  2. Hip Disability and Osteoarthritis Outcome Score, Junior (HOOS Jr)

    Patient-administered self-report survey based on the HOOS that specifically focuses on the outcome after THA. HOOS, JR. consists of 2 areas: pain (2 items) and function, daily living (4 items). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes - none, mild, moderate, severe, extreme) and each question gets a score from 0 to 4. An interval score from 0 -100 (0 indicating total hip disability and 100 indicating perfect hip health) is calculated.

    Measured: Pre-operative, 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years post-operative

  3. EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS)

    The VAS records the subject's self-rated health on a vertical visual analogue scale. The endpoints on the scale are labelled "The best health you can imagine" and "The worst health you can imagine". Participants indicate a numerical value from 1-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents.

    Measured: Pre-operative, 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years post-operative

  4. Quality of Life (EQ-5D-5L) Index Score

    The descriptive system is used to describe the subject's health state \& consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems, and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'.) The digits for the 5 dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. A higher number is a better outcome.

    Measured: Pre-operative, 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2024
  2. Study start26 Sep 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06564636
Sponsor's protocol ID
CATALYST.2023.02
Acronym
CATALYSTEM
Status last verified
Mar 2026
First submitted
19 Aug 2024
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Total Hip Arthroplasty (THA) and Osteoarthritis, run by Smith & Nephew, Inc. at 10 sites in 2 countries.

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 40 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Collared CATALYSTEM™ femoral stem implant survivorship 2 years post-operatively (time frame: 2 years post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06564636.

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 12 Mar 2026.

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