A Multi-centre Study to Assess the Long-term Performance of the Silent Hip™ in Primary Total Hip Replacement Surgery

DePuy Synthes

Status: Terminated

Conditions: Secondary Arthritis; Primary Arthritis

Treatments: Device: Silent™ Hip

Study type: Interventional

Funder types: Industry

Identifiers

NCT01383824

CT09/02

Details and patient eligibility

About

The purpose of this study is to monitor the performance and of the Silent Hip™ in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

Enrollment: 89 patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any subject deemed suitable to receive the Silent™ Hip in combination with the Pinnacle™ acetabular cup system, in accordance with all applicable Instructions For Use, should be considered for entry into this study.

Exclusion criteria

• Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

89 participants in 1 patient group

Silent™ Hip

Other group

Description:

A short cementless, femoral component for use in total hip arthroplasty

Treatment:

Device: Silent™ Hip