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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00878046
• Other study ID #: CT05/01
• Status: Terminated
• Phase: N/A
• First received: April 7, 2009
• Last updated: April 20, 2016
• Start date: May 2005
• Est. completion date: November 2014

Study information

• Verified date: March 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: November 2014
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• DePuy Silent™ Hip femoral prosthesis
A short cementless, femoral component for use in total hip arthroplasty

Locations

Country	Name	City	State
Australia	Royal Newcastle Hospital	Broadmeadow
Australia	Prince of Wales Private Hospital	Sydney
Australia	Sydney Adventist Hospital	Sydney
France	Hôpital Raymond Poincaré	Garches
Germany	Orthopädishe Universitätsklinik	Frankfurt
Italy	Ospedali Riuniti di Jesi	Jesi
United Kingdom	Llandough Hospital	Cardiff

Sponsors (2)

Lead Sponsor	Collaborator
DePuy International	Johnson & Johnson

Countries where clinical trial is conducted

Australia,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complications		6mths post-surgery	Yes
Primary	Harris Hip score change at 6mths post-surgery		6mths post-surgery	No
Secondary	Harris Hip Score		3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery	No
Secondary	Oxford Hip Score		3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery	No
Secondary	UCLA Activity Rating		3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery	No
Secondary	Incidence of post operative radiological signs		7 days, 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery	No
Secondary	Change in bone mineral density		7days, 3mths, 6mths, 1yr and 2yrs post-surgery	No
Secondary	Kaplan-Meier Survivorship Calculations		3 months, 6 months, and Annually	Yes