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

Primary Purpose

Osteoarthritis

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

DePuy Silent™ Hip femoral prosthesis

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Hip, Cementless, Conservative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royal Newcastle Hospital
Prince of Wales Private Hospital
Sydney Adventist Hospital
Hôpital Raymond Poincaré
Orthopädishe Universitätsklinik
Ospedali Riuniti di Jesi
Llandough Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DePuy Silent™ Hip femoral prosthesis

Arm Description

A short cementless, femoral component for use in total hip arthroplasty

Outcomes

Primary Outcome Measures

Incidence of complications

Harris Hip score change at 6mths post-surgery

Secondary Outcome Measures

Harris Hip Score

Oxford Hip Score

UCLA Activity Rating

Incidence of post operative radiological signs

Change in bone mineral density

Kaplan-Meier Survivorship Calculations

Full Information

NCT ID

NCT00878046

First Posted

April 7, 2009

Last Updated

April 20, 2016

Sponsor

DePuy International

Collaborators

Johnson & Johnson

1. Study Identification

Unique Protocol Identification Number

NCT00878046

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Terminated

Why Stopped

The Silent Hip has been rationalized for business reasons only

Study Start Date

May 2005 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DePuy International

Collaborators

Johnson & Johnson

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

Hip, Cementless, Conservative

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DePuy Silent™ Hip femoral prosthesis

Arm Type

Experimental

Arm Description

A short cementless, femoral component for use in total hip arthroplasty

Intervention Type

Device

Intervention Name(s)

DePuy Silent™ Hip femoral prosthesis

Intervention Description

A short cementless, femoral component for use in total hip arthroplasty

Primary Outcome Measure Information:

Title

Incidence of complications

Time Frame

6mths post-surgery

Title

Harris Hip score change at 6mths post-surgery

Time Frame

6mths post-surgery

Secondary Outcome Measure Information:

Title

Harris Hip Score

Time Frame

3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery

Title

Oxford Hip Score

Time Frame

3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery

Title

UCLA Activity Rating

Time Frame

3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery

Title

Incidence of post operative radiological signs

Time Frame

7 days, 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery

Title

Change in bone mineral density

Time Frame

7days, 3mths, 6mths, 1yr and 2yrs post-surgery

Title

Kaplan-Meier Survivorship Calculations

Time Frame

3 months, 6 months, and Annually

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Royal Newcastle Hospital

City

Broadmeadow

Country

Australia

Facility Name

Prince of Wales Private Hospital

City

Sydney

Country

Australia

Facility Name

Sydney Adventist Hospital

City

Sydney

Country

Australia

Facility Name

Hôpital Raymond Poincaré

City

Garches

Country

France

Facility Name

Orthopädishe Universitätsklinik

City

Frankfurt

Country

Germany

Facility Name

Ospedali Riuniti di Jesi

City

Jesi

Country

Italy

Facility Name

Llandough Hospital

City

Cardiff

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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