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

A Multi-centre, Prospective, Uncontrolled Post Market Clinical Follow-up Study (PMCFS) to Monitor the Survival and Performance of the Silent™ Hip in Subjects Requiring a Total Hip Replacement

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01383824

Enrollment

Registered

2011-06-28

Start date

2011-01-31

Completion date

2015-07-31

Last updated

2016-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Arthritis, Secondary Arthritis

Keywords

Hip Replacement, Femoral Component

Brief summary

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.

Interventions

DEVICESilent™ Hip

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Kaplan-Meier survivorship	5 years post-surgery

Secondary

Measure	Time frame
Oxford Hip Score	6 weeks-6 mths
University of California Los Angeles (UCLA) Activity Score	6 weeks-6 mths
EuroQol EQ-5D	6 weeks-6 mths
Harris Hip Score	6 weeks-6 mths
Radiographic analysis	pre-discharge

Countries

Denmark, Germany, Italy, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026