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

This study has been terminated.
(Rationalization of the Silent Hip Prosthesis for business reasons only)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT01383824
First received: June 27, 2011
Last updated: August 4, 2014
Last verified: August 2014
  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
Primary Arthritis
Secondary Arthritis
Device: Silent™ Hip

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 ]

Enrollment: 89
Study Start Date: January 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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

Locations
Denmark
Sygehus Sønderjyllands
Sønderborg, Denmark
Germany
Orthopädie Kupfalz
Speyer, Germany
Italy
Orthopaedic Clinic University La Sapienza
Rome, Italy
Spain
Hospital Nisa Sevilla-Aljarafe
Sevilla, Spain
Hospital San Juan de Dios del Aljarafe
Sevilla, Spain
Hospital Santa Ángela De La Cruz
Sevilla, Spain
United Kingdom
Princess Alexandra Hospital
Harlow, Essex, United Kingdom
The Rivers Hospital
Sawbridgeworth, Hertfordshire, United Kingdom
Wrightington Hospital
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: August 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by DePuy International:
Hip Replacement
Femoral Component

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014