Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
Start Date
12/8/2023
Completion Date
4/1/2028
Summary
The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.
Detailed Description
The objective of this PMCF Study is to collect data confirming safety, performance and clinical benefits of the Spartan Stem, World Acetabular Cup and the World Liner when used for primary total hip arthroplasty at 2-years follow-up. The study includes pre-operative, operative, discharge, 1 year post-operative evaluations, where data concerning the performance and safety of the device are gathered. The revision rate of the components will be monitored as the primary objective, along with pre and post operative measurement of the Oxford Hip Score (OHS), patient-reported outcome measure (PROM) to quantify patient satisfaction. Radiography analysis will be done to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Spartan Stem, World Acetabular Cup and World Liner
Conditions
Locations
Cleveland Clinic
Cleveland, Ohio 44195
United States