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CATALYSTEM for Congenital Hip Dysplasia (CATALYSTEM Trial)
N/A
Waitlist Available
Research Sponsored by Smith & Nephew, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative, 6-weeks, 1-year, 2-years and 5 years post-operative
Awards & highlights
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.
Eligible Conditions
- Congenital Hip Dysplasia
- Osteoarthritis
- Avascular Necrosis
- Arthritis
- Total Hip Replacement
- Rheumatoid Arthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ preoperative, 6-weeks, 1-year, 2-years and 5 years post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative, 6-weeks, 1-year, 2-years and 5 years post-operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CATALYSTEM™ femoral stem implant survivorship 2 years post-operatively by stem type (collared/collarless)
Secondary study objectives
CATALYSTEM™ femoral stem implant survivorship rates by stem type (collard/collarless)
EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS)
Hip Disability and Osteoarthritis Outcome Score, Junior (HOOS Jr)
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CATALYSTEMExperimental Treatment1 Intervention
Participants who have already received or are due to receive the CATALYSTEM Cementless Primary Hip System
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Who is running the clinical trial?
Smith & Nephew, Inc.Lead Sponsor
167 Previous Clinical Trials
21,910 Total Patients Enrolled
Rachel JahnkeStudy DirectorSmith & Nephew, Inc.
1 Previous Clinical Trials
140 Total Patients Enrolled
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