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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Avascular Necrosis; Inflammatory Arthritis; Post-traumatic Arthritis; Congenital Hip Dysplasia; Degenerative Joint Disease; Total Hip Arthroplasty (THA)
• Intervention / Treatment: Device: CATALYSTEM

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.

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • University of British Columbia
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 2M9
      • Concordia General Hospital
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre (LHSC)
• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California at San Francisco
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Connecticut Orthopaedic Institute
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health Inc.
  • Illinois
    • Des Plaines, Illinois, United States, 60016
      • Illinois Bone and Joint Institute
  • New York
    • New York, New York, United States, 10003
      • NYU Langone Health Orthopedic Hospital
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • Duke Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. 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

1. 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

   • 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:

1. 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
2. Subject has a Body Mass Index (BMI) >/= 45 at time of surgery.
3. Subject has a known allergy to one or more components of the study device.
4. 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).
5. 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.
6. Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
7. Women who are pregnant or nursing.
8. Subject has participated previously in this clinical trial and has been withdrawn.
9. Subject has an active infection - systemic or at the site of intended surgery.
10. 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').
11. Subject with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CATALYSTEM; Participants who have already received or are due to receive the CATALYSTEM Cementless Primary Hip System	Device: CATALYSTEM; CATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collared CATALYSTEM™ femoral stem implant survivorship 2 years post-operatively	Stem survivorship is defined as no aseptic revision of the implanted femoral stem	2 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collared CATALYSTEM™ femoral stem implant survivorship rates	Implant survivorship is defined as no aseptic stem revision	6 weeks, 1 year, 3 years, 5 years, 7 years and 10 years post-operative
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.	Pre-operative, 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years post-operative
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.	Pre-operative, 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years post-operative
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.	Pre-operative, 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years post-operative

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Rachel Jahnke, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2036

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: THA; Hip; Total Hip Arthroplasty; Cementless; CATALYST; Hip System; CATALYSTEM; Collared; Collarless; Primary THA
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Rheumatic Diseases; Necrosis; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Arthritis; Joint Diseases; Osteoarthritis; Hip Dislocation, Congenital; Osteonecrosis
• Other Study ID Numbers: CATALYST.2023.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No