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Study to Assess the Stability, Efficacy and Safety of the Silent™ Hip Prosthesis in Primary Total Hip Replacement

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson and Johnson Medical
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00894140
First received: May 5, 2009
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to determine if the Silent™ hip, when used as part of an artificial hip joint, is stable and effective in treatment of patients with joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical, standard and special x-rays (RSA) to allow the position of the Silent Hip within the bone to be accurately 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, Two Centre, EN540, RSA, Pilot Study to Evaluate the Stability, Efficacy and Safety of the Silent Hip Prosthesis in Primary Total Hip Replacement

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • The translational and rotational movements of the Silent™ hip in the 3 dimensions from the baseline position (determined from the 7 day post-operative RSA x-rays) to the 1 year follow-up visit. [ Time Frame: 7day, 3mths, 6mths, and 1yr post-surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Harris Hip Score [ Time Frame: 3mths, 6mths, 1yr, 18mths, 2yrs, 5yrs, and 10yrs post-surgery ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 3mths, 6mths, 1yr, 18mths, 2yrs, 3yrs, 4yrs, 5yrs, 6yrs, 7yrs, 8yrs, 9yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]
  • Incidence of radiological signs on the post-operative x-rays [ Time Frame: 3mths, 6mths, 1 yr, 18mths, 2yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: January 2003
Estimated Study Completion Date: February 2014
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DePuy Silent™ Hip femoral prosthesis
A short cementless, femoral component for use in total hip arthroplasty
 Device: DePuy Silent™ Hip femoral prosthesis
A short cementless, femoral component for use in total hip arthroplasty

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects, aged between 25 and 65 years inclusive.
  2. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
  3. Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
  4. Subjects with non-inflammatory osteoarthritis of the hip who require a primary total hip replacement.

Exclusion Criteria:

  1. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
  2. Women who are pregnant.
  3. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  4. Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
  5. Subjects who are currently involved in any injury litigation claims.
  6. Subjects who have osteonecrosis of the femoral neck
  7. Subjects who have an existing contralateral hip, ankle or knee replacement or an ipsilateral knee or ankle replacement or any metal implant in the lower lumber spine (navigated cases only).
  8. Subjects who are greater than 90kg in weight.
  9. Subject who have a CCD angle of the anatomical femur less than 125˚
  10. 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 prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the prosthesis.
  11. Subjects with a Charnley C classification.
  12. Subjects with an active local or systemic infection.
  13. Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the arthroplasty procedure unjustified.
  14. Subjects with Paget's disease
  15. Subjects who still plan in the future to have children.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894140

Locations
Australia
Sydney Adventist Hospital
Sydney, Australia
Germany
General Hospital Eilbek
Hamburg, Germany
Sponsors and Collaborators
DePuy International
Johnson and Johnson Medical
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00894140     History of Changes
Other Study ID Numbers: CT01/27
Study First Received: May 5, 2009
Last Updated: August 21, 2012
Health Authority: Germany: Amt für Gesundheit und Verbraucherschutz Referat Medizinprodukte

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 June 18, 2013