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Clinical Trials/NCT01383824
NCT01383824
Terminated
Not Applicable

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

DePuy International9 sites in 5 countries89 target enrollmentStarted: January 2011Last updated:
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ConditionsPrimary ArthritisSecondary Arthritis

Overview

Phase
Not Applicable
Status
Terminated
Sponsor
DePuy International
Enrollment
89
Locations
9
Primary Endpoint
Kaplan-Meier survivorship
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Kaplan-Meier survivorship

Time Frame: 5 years post-surgery

Secondary Outcomes

  • University of California Los Angeles (UCLA) Activity Score(15 years)
  • Radiographic analysis(15 Years)
  • Oxford Hip Score(15 Years)
  • EuroQol EQ-5D(15 Years)
  • Harris Hip Score(15 Years)

Investigators

Sponsor
DePuy International
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (9)

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