NCT04255394

Exceed ABT Acetabular Cup Cementless System

A Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data on the Exceed ABT Acetabular Cementless Cup System (Implants and Instruments)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 677 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Post-market Clinical Follow-up Study to provide safety, performance and clinical benefits data on the Exceed ABT acetabular cup (implants and instruments) when used in combination with ceramic liners or polyethylene articulating liners bearing Options. A single-center, cohort observational clinical outcomes study

Detailed description

Study Aim: To collect survivorship and clinical outcomes long-term data confirm-ing safety, performance and clinical benefits of the Exceed ABT ce-mentless cup when used in combination with ceramic and polyeth-ylene articulating liners Objectives: Primary Objectives: Clinical performance - as measured by clinical score data (HHS, WOMAC and Oxford Hip Score), radiographic as-sessments and survivorship which will be based on removal of the device. Secondary Objectives: Safety will be evaluated by monitoring incidence of adverse events. Length of study: 13 years (3 years enrollment plus 10 years follow-up): Post-operative follow-up visits at: 1, 3, 5, 7 and 10 years

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Correction of Functional Deformity

Timeline

• Start date: 2010-07-01
• Primary completion: 2022-02-28
• Completion: 2022-03-31
• First posted: 2020-02-05
• Last updated: 2024-07-26
• Results posted: 2024-07-26