Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement

Completed

• Conditions: Arthropathy of Hip
• Interventions: Device: Total Hip arthroplasty

• Registration Number: NCT01684631
• Lead Sponsor: DePuy International

Brief Summary

The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-13
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Patients susceptible to receive a PINNACLE® ULTAMET™ implant as per routine practice

Exclusion Criteria

• Patient refusal to participate to the data collection
• Pregnant woman
• Patients age is less than 18 years old
• The planned intervention is a revision of a previous intervention on the studied hip joint
• Previous metal implant, except for pure titanium or titanium alloys
• Exposure to cobalt and chromium that could influence serum metal ions levels
• Planned bilateral intervention
• Patient residing outside France
• Patient not implanted with a Pinnacle(R) ULTAMET(TM)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hip arthroplasty	Total Hip arthroplasty	Patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease or true femoral cervical fracture.

Primary Outcome Measures

Name	Time	Method
Implant Survival Rate	up to 5 years	Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause.

Secondary Outcome Measures

Name	Time	Method
Harris Hip Score	pre-operative, 1, 2, 3, 5 years	Measure of hip function using the Harris Hip Score

Trial Locations

Locations (6)

Centre Hospitalier Georges Renon; 🇫🇷 Niort, France

Clinique Pasteur; 🇫🇷 Royan, France

Clinique Mutualiste Saint Etienne; 🇫🇷 Saint Etienne, France

Clinique Saint Hilaire; 🇫🇷 Rouen, France

Clinique Herbert; 🇫🇷 Aix-les-Bains, France

Clinique Bonnefon; 🇫🇷 Ales, France