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

DePuy Synthes

Status: Completed

Conditions: Arthropathy of Hip

Treatments: Device: Total Hip arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT01684631

27062008

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

107 participants in 1 patient group

Hip arthroplasty

Description:

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.

Treatment:

Device: Total Hip arthroplasty