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

Secondary Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01383824
• Other study ID #: CT09/02
• Status: Terminated
• Phase: N/A
• First received: June 27, 2011
• Last updated: May 25, 2016
• Start date: January 2011
• Est. completion date: July 2015

Study information

• Verified date: August 2014
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: July 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Primary Arthritis
• Secondary Arthritis

Intervention

Device:
• Silent™ Hip
A short cementless, femoral component for use in total hip arthroplasty

Locations

Country	Name	City	State
Denmark	Sygehus Sønderjyllands	Sønderborg
Germany	Orthopädie Kupfalz	Speyer
Italy	Orthopaedic Clinic University La Sapienza	Rome
Spain	Hospital Nisa Sevilla-Aljarafe	Sevilla
Spain	Hospital San Juan de Dios del Aljarafe	Sevilla
Spain	Hospital Santa Ángela De La Cruz	Sevilla
United Kingdom	Princess Alexandra Hospital	Harlow	Essex
United Kingdom	The Rivers Hospital	Sawbridgeworth	Hertfordshire
United Kingdom	Wrightington Hospital	Wrightington	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

Denmark,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier survivorship		5 years post-surgery	Yes
Secondary	Oxford Hip Score		6 weeks-6 mths	No
Secondary	University of California Los Angeles (UCLA) Activity Score		6 weeks-6 mths	No
Secondary	EuroQol EQ-5D		6 weeks-6 mths	No
Secondary	Harris Hip Score		6 weeks-6 mths	No
Secondary	Radiographic analysis		pre-discharge	No
Secondary	Oxford Hip Score		2 years	No
Secondary	Oxford Hip Score		3 years	No
Secondary	Oxford Hip Score		4 Years	No
Secondary	Oxford Hip Score		5 years	No
Secondary	Oxford Hip Score		6 Years	No
Secondary	Oxford Hip Score		7 Years	No
Secondary	Oxford Hip Score		8 Years	No
Secondary	Oxford Hip Score		9 years	No
Secondary	Oxford Hip Score		10 Years	No
Secondary	Oxford Hip Score		11 Years	No
Secondary	Oxford Hip Score		12 Years	No
Secondary	Oxford Hip Score		13 Years	No
Secondary	Oxford Hip Score		14 Years	No
Secondary	Oxford Hip Score		15 Years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		2 years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		3 years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		4 Years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		5 Years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		6 Years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		7 Years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		8 Years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		9 years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		10 Years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		11 Years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		12 Years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		13 Years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		14 Years	No
Secondary	University of California Los Angeles (UCLA) Activity Score		15 years	No
Secondary	EuroQol EQ-5D		2 Years	No
Secondary	EuroQol EQ-5D		3 Years	No
Secondary	EuroQol EQ-5D		4 Years	No
Secondary	EuroQol EQ-5D		5 Years	No
Secondary	EuroQol EQ-5D		6 years	No
Secondary	EuroQol EQ-5D		7 years	No
Secondary	EuroQol EQ-5D		8 Years	No
Secondary	EuroQol EQ-5D		9 Years	No
Secondary	EuroQol EQ-5D		10 Years	No
Secondary	EuroQol EQ-5D		11 Years	No
Secondary	EuroQol EQ-5D		12 Years	No
Secondary	EuroQol EQ-5D		13 Years	No
Secondary	EuroQol EQ-5D		14 Years	No
Secondary	EuroQol EQ-5D		15 Years	No
Secondary	Harris Hip Score		2 Years	No
Secondary	Harris Hip Score		5 Years	No
Secondary	Harris Hip Score		10 Years	No
Secondary	Harris Hip Score		15 Years	No
Secondary	Radiographic analysis		6 weeks - 6 mths	No
Secondary	Radiographic analysis		1 year	No
Secondary	Radiographic analysis		2 Years	No
Secondary	Radiographic analysis		5 Years	No
Secondary	Radiographic analysis		10 years	No
Secondary	Radiographic analysis		15 Years	No