NCT02369497

Ascension® Humeral Resurfacing Arthroplasty (HRA) Follow-Up Study

Ascension® Humeral Resurfacing Arthroplasty HRA Follow-Up Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective study on the Ascension HRA device to collect data to assess the safety and effectiveness of the HRA.

Detailed description

This study protocol will provide guidance to investigators wanting to perform a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are treated with the Ascension® HRA. Its purpose is to measure and document the outcomes associated with implanting the Ascension HRA prosthesis. Patients will be periodically assessed to collect data related to safety and effectiveness endpoints at the following intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5 year, and 10 years.

Conditions

• Arthritis

Interventions

Type	Name	Description
DEVICE	HRA	Humeral head resurfacing with the HRA device

Timeline

• Start date: 2007-12-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2015-02-24
• Last updated: 2015-02-24

Locations

1 site across 1 country: United States