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

NCT06564636 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CATALYST.2023.02
• Study Type: observational
• Target: 119
• Locations: 2 countries
• Sites: 10

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Collared CATALYSTEM™ femoral stem implant survivorship rates

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

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

  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)

  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

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

Study Arms (1)

CATALYSTEM

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

Device: CATALYSTEM

Interventions

CATALYSTEM DEVICE

CATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty

CATALYSTEM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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\*\*
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (10)

University of California at San Francisco

San Francisco, California, 94158, United States

Location

Connecticut Orthopaedic Institute

Hamden, Connecticut, 06518, United States

Location

Orlando Health Inc.

Orlando, Florida, 32806, United States

Location

Illinois Bone and Joint Institute

Des Plaines, Illinois, 60016, United States

Location

NYU Langone Health Orthopedic Hospital

New York, New York, 10003, United States

Location

Duke Health

Morrisville, North Carolina, 27560, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Concordia General Hospital

Winnipeg, Manitoba, R2K 2M9, Canada

Location

London Health Sciences Centre (LHSC)

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases; Arthritis; Osteonecrosis; Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rachel Jahnke

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: September 26, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2036
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (6); CA (4)