Multi-Centre Study to Assess the Long-Term Safety and Efficacy of the Silent™ Hip Prosthesis in Primary Total Hip Replacement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by DePuy International.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
DePuy International
ClinicalTrials.gov Identifier:
NCT00878046
First received: April 7, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

The purpose of this study is to determine if the Silent™ hip, when used as part of an artificial hip joint, is effective 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. A subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored


Condition Intervention Phase
Osteoarthritis
Device: DePuy Silent™ Hip femoral prosthesis
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Non-Comparative, Multi-Centre Study to Evaluate the Safety and Efficacy of the DePuy Silent™ Hip Prosthesis in Primary Total Hip Replacement

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Incidence of complications [ Time Frame: 6mths post-surgery ] [ Designated as safety issue: Yes ]
  • Harris Hip score change at 6mths post-surgery [ Time Frame: 6mths post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • UCLA Activity Rating [ Time Frame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Incidence of post operative radiological signs [ Time Frame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Change in bone mineral density [ Time Frame: 7days, 3mths, 6mths, 1yr and 2yrs post-surgery ] [ Designated as safety issue: No ]
  • Kaplan-Meier Survivorship Calculations [ Time Frame: Annually ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: May 2005
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: DePuy Silent™ Hip femoral prosthesis
    A short cementless, femoral component for use in total hip arthroplasty
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i) Male or female subjects, aged 18 years or above at the point of screening for participation.

ii) Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-treatment follow-ups.

iv) Subjects with non-inflammatory osteoarthritis of the hip who require a primary total hip replacement and are considered suitable for a cementless femoral and acetabular component.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 months. This exclusion does not apply to those subjects who are participating in the pilot investigation of the DePuy Silent Hip (CT01/27)

v) Subjects who are currently involved in any injury litigation claims.

vi) Subjects who have osteonecrosis of the femoral neck

vii) Subjects with significant bone loss or gross deformity in the region of the neck of the femur as identified on the pre-operative radiographs, where in the Investigator's opinion, there could be considerable migration of the DePuy Silent Hip or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the DePuy Silent Hip.

viii) Subjects with a Charnley C classification.

ix) Subjects with an active local or systemic infection.

x) Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the arthroplasty procedure unjustified.

xi) Subjects with Paget's disease

  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: NCT00878046

Locations
Australia
Royal Newcastle Hospital
Broadmeadow, Australia
Sydney Adventist Hospital
Sydney, Australia
Prince of Wales Private Hospital
Sydney, Australia
France
Hôpital Raymond Poincaré
Garches, France
Germany
Orthopädishe Universitätsklinik
Frankfurt, Germany
Italy
Ospedali Riuniti di Jesi
Jesi, Italy
United Kingdom
Llandough Hospital
Cardiff, United Kingdom
Sponsors and Collaborators
DePuy International
Johnson & Johnson
  More Information

No publications provided

Responsible Party: Michael Borroff, B.Sc., M.Sc. Study Director, DePuy International Ltd
ClinicalTrials.gov Identifier: NCT00878046     History of Changes
Other Study ID Numbers: CT05/01
Study First Received: April 7, 2009
Last Updated: April 7, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by DePuy International:
Hip
Cementless
Conservative

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014