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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by DePuy International
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01383824
First received: June 27, 2011
Last updated: February 20, 2013
Last verified: February 2013

June 27, 2011
February 20, 2013
January 2011
March 2019   (final data collection date for primary outcome measure)
Kaplan-Meier survivorship [ Time Frame: 5 years post-surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01383824 on ClinicalTrials.gov Archive Site
  • Oxford Hip Score [ Time Frame: 6 weeks-6 mths ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 6 weeks-6 mths ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 6 weeks-6 mths ] [ Designated as safety issue: No ]
  • Harris Hip Score [ Time Frame: 6 weeks-6 mths ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: pre-discharge ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 9 years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 11 Years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 12 Years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 13 Years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 14 Years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 15 Years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 9 years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 11 Years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 12 Years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 13 Years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 14 Years ] [ Designated as safety issue: No ]
  • University of California Los Angeles (UCLA) Activity Score [ Time Frame: 15 years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 9 Years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 11 Years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 12 Years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 13 Years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 14 Years ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 15 Years ] [ Designated as safety issue: No ]
  • Harris Hip Score [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Harris Hip Score [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Harris Hip Score [ Time Frame: 10 Years ] [ Designated as safety issue: No ]
  • Harris Hip Score [ Time Frame: 15 Years ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: 6 weeks - 6 mths ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: 15 Years ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 6 weeks-6 mths, 2 yrs, 3yrs, 4yrs, 5yrs, 6yrs,7yrs, 8yrs, 9yrs, 10yrs, 11yrs, 12yrs, 13yrs 14yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • UCLA Activity Score [ Time Frame: 6 weeks-6 mths, 2 yrs, 3yrs, 4yrs, 5yrs, 6yrs,7yrs, 8yrs, 9yrs, 10yrs, 11yrs, 12yrs, 13yrs 14yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • EQ5D [ Time Frame: 6 weeks-6 mths, 2 yrs, 3yrs, 4yrs, 5yrs, 6yrs,7yrs, 8yrs, 9yrs, 10yrs, 11yrs, 12yrs, 13yrs 14yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Harris Hip Score [ Time Frame: 6 weeks-6 mths, 2yrs, 5yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: pre-discharge, 6 weeks-6 mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Arthritis
  • Secondary Arthritis
Device: Silent™ Hip
A short cementless, femoral component for use in total hip arthroplasty
Silent™ Hip
A short cementless, femoral component for use in total hip arthroplasty
Intervention: Device: Silent™ Hip
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
March 2029
March 2019   (final data collection date for primary outcome measure)

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.
Both
up to 65 Years
No
Contact: Carol Picker, B.Sc. +44 113 387 7800 ext 7815 cpicker@its.jnj.com
Denmark,   Germany,   Italy,   Spain,   United Kingdom
 
NCT01383824
CT09/02
No
DePuy International
DePuy International
Not Provided
Not Provided
DePuy International
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP