A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System
Overview
- Phase
- N/A
- Intervention
- CATALYSTEM
- Conditions
- Total Hip Arthroplasty (THA)
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 119
- Locations
- 20
- Primary Endpoint
- Collared CATALYSTEM™ femoral stem implant survivorship 2 years post-operatively
- Status
- Active, Not Recruiting
- Last Updated
- last month
Overview
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 10 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 Collared CATALYSTEM™ Hip System femoral stem with standard or high offset in primary THA procedures. Stem survivorship is defined as no aseptic revision (i.e., revision for any reason except infection) of the implanted femoral stem.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\*\*
- •° PROMs (HOOS, JR., and EQ-5D-5L), and
Exclusion Criteria
- •Any one (1) of the following criteria will disqualify a potential subject from participation in the study:
- •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.
Arms & Interventions
CATALYSTEM
Participants who have already received or are due to receive the CATALYSTEM Cementless Primary Hip System
Intervention: CATALYSTEM
Outcomes
Primary Outcomes
Collared CATALYSTEM™ femoral stem implant survivorship 2 years post-operatively
Time Frame: 2 years post-operative
Stem survivorship is defined as no aseptic revision of the implanted femoral stem
Secondary Outcomes
- 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)