NCT01383824

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
5 countries

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 27, 2016

Status Verified

August 1, 2014

Enrollment Period

2.5 years

First QC Date

June 27, 2011

Last Update Submit

May 25, 2016

Conditions

Primary ArthritisSecondary Arthritis

Keywords

Hip ReplacementFemoral Component

Outcome Measures

Primary Outcomes (1)

  • Kaplan-Meier survivorship

    5 years post-surgery

Secondary Outcomes (57)

  • 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

  • +52 more secondary outcomes

Study Arms (1)

Silent™ Hip

OTHER

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

Device: Silent™ Hip

Interventions

Silent™ HipDEVICE

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

Silent™ Hip

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Sygehus Sønderjyllands

Sønderborg, Denmark

Location

Orthopädie Kupfalz

Speyer, Germany

Location

Orthopaedic Clinic University La Sapienza

Rome, Italy

Location

Hospital Nisa Sevilla-Aljarafe

Seville, Spain

Location

Hospital San Juan de Dios del Aljarafe

Seville, Spain

Location

Hospital Santa Ángela De La Cruz

Seville, Spain

Location

Princess Alexandra Hospital

Harlow, Essex, United Kingdom

Location

The Rivers Hospital

Sawbridgeworth, Hertfordshire, United Kingdom

Location

Wrightington Hospital

Wrightington, Lancashire, WN6 9EP, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 28, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2015

Last Updated

May 27, 2016

Record last verified: 2014-08

Locations

DK(1)DE(1)GB(3)ES(3)IT(1)