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

Not yet recruiting

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Inclusion Criteria:<br><br>1a. Subject needing primary THA due to end stage degenerative joint disease (primary<br>diagnosis of osteoarthritis), avascular necrosis, post-traumatic arthritis, inflammatory<br>arthritis, or congenital hip dysplasia.<br><br>OR<br><br> 1. b. Subject has undergone primary THA with the S+N CATALYSTEM™ Primary Hip stem in<br> the past 12 months for end stage degenerative joint disease (primary diagnosis of<br> osteoarthritis), avascular necrosis, post-traumatic arthritis, inflammatory<br> arthritis, or congenital hip dysplasia and all the following conditions have been<br> met for the appropriate timepoint:<br><br> - Preoperative Patient Reported Outcome Measures (PROMs):<br><br> - Hip Disability and Osteoarthritis Outcome Score Junior (HOOS, JR.)<br><br> - European Quality of Life (EuroQol) Five-dimensional Five-level (EQ-5D-5L)<br> 21, and<br><br> - Pain Visual Analog Scale (VAS) and<br><br> - Radiographs have been obtained:<br><br> ° Anterior Posterior (AP) Pelvis<br><br> ° AP Hip*, and<br><br> ° Lateral**<br><br> - 6-Weeks<br><br> - PROMs (HOOS, JR., EQ-5D-5L, and VAS), and<br><br> - Radiographs (AP Pelvis, AP Hip*, and Lateral**) have been obtained or<br> these can be collected prospectively in window per schedule of events, and<br><br> - 1-Year<br><br> ° PROMs (HOOS, JR., EQ-5D-5L, and VAS), and<br><br> - Radiographs (AP Pelvis, AP Hip*, and Lateral**) have been obtained or<br> these can be collected prospectively in window per schedule of events<br><br> 2. Subject agrees to consent and to follow the prospective study visit<br> schedule by signing the Independent Review Board (IRB)/Independent<br> Ethics Committee (IEC) approved Informed Consent Form (ICF).<br><br> 3. Subject is eighteen to eighty (18-80) years old (inclusive).<br><br> 4. Subject can read, understand, and communicate responses to the PROMs.<br><br>footnote:<br><br>For the AP Hip radiograph, sites MUST ensure that positioning (standing AP Hip vs.<br>supine AP Hip) is consistent across all study visits for an individual subject (i.e. if<br>subject had standing AP Hip at pre-op then collect standing AP Hip at all visits for that<br>subject).<br><br>* Lateral radiograph is to include any one of the following, but for standardization,<br>sites MUST ensure consistency across all study visits for an individual subject:<br>Cross-Table Lateral (CTL) or Frog-lateral or lateral femoral/Lowenstein (i.e. if subject<br>had frog-leg lateral at pre- op then collect frog-leg lateral at all visits for that<br>subject).<br><br>Exclusion Criteria: Any one (1) of the following criteria will disqualify a potential<br>subject from participation in the study:<br><br> 1. Subject has conditions that would eliminate or tend to eliminate adequate implant<br> support or prevent the use of an appropriately-sized implant, e.g.:<br><br> - Blood supply limitations<br><br> - Insufficient quantity or quality of bone support e.g., osteoporosis, or<br> metabolic disorders which may impair bone formation, and or osteomalacia<br><br> - Mental or neurological conditions which may tend to impair the patient's<br> ability or willingness to restrict activities; or impairing or precluding<br> cooperation with post-operative protocols including mental illness, drug or<br> alcohol abuse.<br><br> - Physical conditions or activities which tend to place extreme loads on implants<br> and may impair short and long-term satisfactory results of the implant, e.g.,<br> Charcot joints, muscle deficiencies, multiple joint disabilities, etc.<br><br> - Infections or other conditions which may lead to increased bone resorption<br><br> - Skeletal immaturity<br><br> 2. Subject has a Body Mass Index (BMI) > 45 at time of surgery.<br><br> 3. Subject has a known allergy to one or more components of the study device.<br><br> 4. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section<br> 3.55 (i.e., individuals who are unable to fully understand all aspects of the<br> investigation that are relevant to the decision to participate, or who could be<br> manipulated or unduly influenced as a result of a compromised position, expectation<br> of benefits or fear of retaliatory response).<br><br> 5. Subject is entered in another drug, biologic, or device study or has been treated<br> with an investigational product 30 days prior to the surgery date.<br><br> 6. Subject is known to be at risk for lost to follow-up, or failure to return for<br> scheduled visits.<br><br> 7. Women who are pregnant or nursing.<br><br> 8. Subject has participated previously in this clinical trial and has been withdrawn.<br><br> 9. Subject has an active infection - systemic or at the site of intended surgery.<br><br> 10. Subject had a contralateral (opposite) hip replacement that was implanted less than<br> 3 months prior to consent, is scheduled for a simultaneous contralateral hip<br> implant, or plans to have their contralateral hip implanted within 3 months<br> following this study-specific implant (known as 'staged bilateral THA').<br><br> 11. Subject with a medical or physical condition that, in the opinion of the<br> Investigator, would preclude safe subject participation in the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CATALYSTEM™ femoral stem implant survivorship 2 years post-operatively by stem type (collared/collarless)

Secondary Outcome Measures

Name	Time	Method
CATALYSTEM™ femoral stem implant survivorship rates by stem type (collard/collarless);Hip Disability and Osteoarthritis Outcome Score, Junior (HOOS Jr);EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS);Quality of Life (EQ-5D-5L) Index Score;Pain Visual Analog Scale (VAS);Radiographic findings: Femoral Stem Subsidence;Radiographic Findings - Loosening;Radiographic Findings - Femoral Stem Osteolysis;Radiographic Findings - Osseointegration Status of Femoral Stem;Radiographic Findings - Progressive Radiolucency