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

• Conditions: Osteoarthritis; Avascular Necrosis; Post-traumatic Arthritis; Degenerative Joint Disease; Total Hip Arthroplasty (THA); Inflammatory Arthritis; Congenital Hip Dysplasia
• Interventions: Device: CATALYSTEM

• Registration Number: NCT06564636
• Lead Sponsor: Smith & Nephew, Inc.

Brief 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.

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 5 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 CATALYSTEM™ Hip System (i.e. the femoral stem with all its variants and instrumentation) in primary THA procedures for each stem type (Collared/Collarless). Stem survivorship is defined as no aseptic revision of the implanted femoral stem.

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-21
• Study Start: 2024-09-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-12
• Study Completion: 2030-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 198

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.

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 Hip radiograph, sites MUST ensure that positioning (standing AP Hip vs. supine AP Hip) is consistent across all study visits for an individual subject (i.e. if subject had standing AP Hip at pre-op then collect standing AP Hip at all visits for that subject).

** Lateral radiograph is to include any one of the following, but for standardization, sites MUST ensure consistency across all study visits for an individual subject: Cross-Table Lateral (CTL) or Frog-lateral or lateral femoral/Lowenstein (i.e. if subject had frog-leg lateral at pre- op then collect frog-leg lateral at all visits for that subject).

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CATALYSTEM	CATALYSTEM	Participants who have already received or are due to receive the CATALYSTEM Cementless Primary Hip System

Primary Outcome Measures

Name	Time	Method
CATALYSTEM™ femoral stem implant survivorship 2 years post-operatively by stem type (collared/collarless)	2 years post-operative	Stem survivorship is defined as no aseptic revision of the implanted femoral stem

Secondary Outcome Measures

Name	Time	Method
CATALYSTEM™ femoral stem implant survivorship rates by stem type (collard/collarless)	6 weeks, 1 year, and 5 years post-operative	Implant survivorship is defined as no aseptic stem revision
Hip Disability and Osteoarthritis Outcome Score, Junior (HOOS Jr)	Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative	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.
EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS)	Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative	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.
Quality of Life (EQ-5D-5L) Index Score	Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative	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.

Trial Locations

Locations (12)

Orlando Health Inc.; 🇺🇸 Orlando, Florida, United States

Illinois Bone and Joint Institute; 🇺🇸 Des Plaines, Illinois, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Connecticut Orthopaedic Institute; 🇺🇸 Hamden, Connecticut, United States

NYU Langone Health Orthopedic Hospital; 🇺🇸 New York, New York, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Concordia General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

London Health Sciences Centre (LHSC); 🇨🇦 London, Ontario, Canada

Duke Health; 🇺🇸 Morrisville, North Carolina, United States