NCT04425603

Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 270 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This clinical study will verify the clinical and radiographic performance of the prosthesis when used in human subjects over a period of 10 years. All complications will be documented.

Detailed description

The clinical evaluations will be based on standard, functional and pain parameters Harris Hip Score pre-operatively, and at 6 months, 3, 5, 7.5 and 10 years post-operatively. Postal Oxford questionnaire preoperatively, and yearly thereafter. The objective of this study is to analyse the clinical and radiographic responses and the complication rates for patients undergoing primary total hip arthroplasty using the Anthology Hip Replacement System (Anthology Hip System).

Conditions

• Primary Osteoarthritis
• Secondary Osteoarthritis
• Avascular Necrosis
• Primary Total Hip Replacement (THR)

Interventions

Type	Name	Description
DEVICE	Anthology Hip Replacement System

Timeline

• Start date: 2007-04-30
• Primary completion: 2021-11-08
• Completion: 2021-11-08
• First posted: 2020-06-11
• Last updated: 2022-09-30

Locations

4 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated device study