Multi-centre Study to Assess Long-term Safety and Efficacy of the Silent™ Hip Prosthesis in Primary THR

A Non-comparative, Multi-centre Study to Evaluate the Safety and Efficacy of the DePuy Silent™ Hip Prosthesis in Primary Total Hip Replacement

The purpose of this study is to determine if the Silent™ hip 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

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: DePuy Silent™ Hip femoral prosthesis

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Broadmeadow, Australia
    • Royal Newcastle Hospital
  • Sydney, Australia
    • Prince of Wales Private Hospital
  • Sydney, Australia
    • Sydney Adventist Hospital
• France
  • Garches, France
    • Hôpital Raymond Poincaré
• Germany
  • Frankfurt, Germany
    • Orthopädishe Universitätsklinik
• Italy
  • Jesi, Italy
    • Ospedali Riuniti di Jesi
• United Kingdom
  • Cardiff, United Kingdom
    • LLandough Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects, aged 18 years or above at the point of screening for participation.
• Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
• 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.
• 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:

• Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
• Women who are pregnant.
• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
• 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)
• Subjects who are currently involved in any injury litigation claims.
• Subjects who have osteonecrosis of the femoral neck
• 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.
• Subjects with a Charnley C classification.
• Subjects with an active local or systemic infection.
• Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the arthroplasty procedure unjustified.
• Subjects with Paget's disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of complications	6mths post-surgery
Harris Hip score change at 6mths post-surgery	6mths post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Harris Hip Score	3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Oxford Hip Score	3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
UCLA Activity Rating	3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Incidence of post operative radiological signs	7 days, 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Change in bone mineral density	7days, 3mths, 6mths, 1yr and 2yrs post-surgery
Kaplan-Meier Survivorship Calculations	3 months, 6 months, and Annually

Collaborators and Investigators

• Sponsor: DePuy International
• Collaborators: Johnson & Johnson

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: April 7, 2009
• First Submitted That Met QC Criteria: April 7, 2009
• First Posted (Estimate): April 8, 2009

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Hip; Cementless; Conservative
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CT05/01