Clinical trial NCT06564636: A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System
Official title: A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Total Hip Arthroplasty (THA)
Osteoarthritis
Degenerative Joint Disease
Inflammatory Arthritis
Avascular Necrosis
Post-traumatic Arthritis
Congenital Hip Dysplasia
Keywords: Total Hip Arthroplasty
THA
Hip System
Hip
CATALYSTEM
CATALYST
Collared
Collarless
Cementless
Primary THA
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-21
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CATALYSTEM™ femoral stem implant survivorship 2 years post-operatively by stem type (collared/collarless)
timeFrame: 2 years post-operative
Secondary outcomes:
measure: CATALYSTEM™ femoral stem implant survivorship rates by stem type (collard/collarless)
timeFrame: 6 weeks, 1 year, and 5 years post-operative
measure: Hip Disability and Osteoarthritis Outcome Score, Junior (HOOS Jr)
timeFrame: Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative
measure: EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS)
timeFrame: Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative
measure: Quality of Life (EQ-5D-5L) Index Score
timeFrame: Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Hamden
country: United States
facility: Connecticut Orthopaedic Institute
state: Connecticut
city: Orlando
country: United States
facility: Orlando Health Inc.
state: Florida
city: Des Plaines
country: United States
facility: Illinois Bone and Joint Institute
state: Illinois
city: New York
country: United States
facility: NYU Langone Health Orthopedic Hospital
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Morrisville
country: United States
facility: Duke Health
state: North Carolina
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: Concordia General Hospital
state: Manitoba
city: London
country: Canada
facility: London Health Sciences Centre (LHSC)
state: Ontario
Study officials:
affiliation: Smith & Nephew, Inc.
name: Rachel Jahnke
role: STUDY_DIRECTOR
References: