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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06564636
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Smith & Nephew, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rachel Jahnke
Principal Investigator Affiliation Smith & Nephew, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Total Hip Arthroplasty (THA), Osteoarthritis, Degenerative Joint Disease, Inflammatory Arthritis, Avascular Necrosis, Post-traumatic Arthritis, Congenital Hip Dysplasia
Additional Details

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.

Arms & Interventions

Arms

: CATALYSTEM

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

Interventions

Device: - CATALYSTEM

CATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Francisco, California

Status

Address

University of California at San Francisco

San Francisco, California, 94158

Connecticut Orthopaedic Institute, Hamden, Connecticut

Status

Address

Connecticut Orthopaedic Institute

Hamden, Connecticut, 06518

Orlando Health Inc., Orlando, Florida

Status

Address

Orlando Health Inc.

Orlando, Florida, 32806

Illinois Bone and Joint Institute, Des Plaines, Illinois

Status

Address

Illinois Bone and Joint Institute

Des Plaines, Illinois, 60016

NYU Langone Health Orthopedic Hospital, New York, New York

Status

Address

NYU Langone Health Orthopedic Hospital

New York, New York, 10003

Hospital for Special Surgery, New York, New York

Status

Address

Hospital for Special Surgery

New York, New York, 10021

Columbia University Medical Center, New York, New York

Status

Address

Columbia University Medical Center

New York, New York, 10032

Duke Health, Morrisville, North Carolina

Status

Address

Duke Health

Morrisville, North Carolina, 27560

International Sites

University of Alberta, Edmonton, Alberta, Canada

Status

Address

University of Alberta

Edmonton, Alberta, T6G 2B7

University of British Columbia, Vancouver, British Columbia, Canada

Status

Address

University of British Columbia

Vancouver, British Columbia, V5Z 1M9

Concordia General Hospital, Winnipeg, Manitoba, Canada

Status

Address

Concordia General Hospital

Winnipeg, Manitoba, R2K 2M9

London Health Sciences Centre (LHSC), London, Ontario, Canada

Status

Address

London Health Sciences Centre (LHSC)

London, Ontario, N6A 5A5