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
  Purpose

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.


Condition Intervention Phase
Primary Arthritis
Secondary Arthritis
Device: Silent™ Hip
Phase 4

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

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship [ Time Frame: 5 years post-surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: January 2011
Estimated Study Completion Date: March 2029
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Silent™ Hip
A short cementless, femoral component for use in total hip arthroplasty
Device: Silent™ Hip
A short cementless, femoral component for use in total hip arthroplasty

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383824

Contacts
Contact: Carol Picker, B.Sc. +44 113 387 7800 ext 7815 cpicker@its.jnj.com

Locations
Denmark
Sygehus Sønderjyllands Recruiting
Sønderborg, Denmark
Germany
Orthopädie Kupfalz Not yet recruiting
Speyer, Germany
Italy
Orthopaedic Clinic University La Sapienza Recruiting
Rome, Italy
Spain
Hospital San Juan de Dios del Aljarafe Recruiting
Sevilla, Spain
Hospital Santa Ángela De La Cruz Recruiting
Sevilla, Spain
Hospital Nisa Sevilla-Aljarafe Recruiting
Sevilla, Spain
United Kingdom
Princess Alexandra Hospital Recruiting
Harlow, Essex, United Kingdom
The Rivers Hospital Recruiting
Sawbridgeworth, Hertfordshire, United Kingdom
Wrightington Hospital Recruiting
Wrightington, Lancashire, United Kingdom, WN6 9EP
Sponsors and Collaborators
DePuy International
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT01383824     History of Changes
Other Study ID Numbers: CT09/02
Study First Received: June 27, 2011
Last Updated: February 20, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 31, 2014