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

NCT00878046 | Terminated

• 1 other identifier: CT05/01
• Study Type: interventional
• Target: 108
• Locations: 5 countries
• Sites: 7

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

Conditions

Osteoarthritis

Keywords

Hip; Cementless; Conservative

Outcome Measures

Primary Outcomes (2)

• Incidence of complications

  6mths post-surgery

• Harris Hip score change at 6mths post-surgery

  6mths post-surgery

Secondary Outcomes (6)

• 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

Study Arms (1)

DePuy Silent™ Hip femoral prosthesis

EXPERIMENTAL

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

Device: DePuy Silent™ Hip femoral prosthesis

Interventions

DePuy Silent™ Hip femoral prosthesis DEVICE

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

DePuy Silent™ Hip femoral prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• DePuy International: lead
• Johnson & Johnson: collaborator

Study Sites (7)

Royal Newcastle Hospital

Broadmeadow, Australia

Location

Prince of Wales Private Hospital

Sydney, Australia

Location

Sydney Adventist Hospital

Sydney, Australia

Location

Hôpital Raymond Poincaré

Garches, France

Location

Orthopädishe Universitätsklinik

Frankfurt, Germany

Location

Ospedali Riuniti di Jesi

Iesi, Italy

Location

Llandough Hospital

Cardiff, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 8, 2009
• Study Start: May 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: November 1, 2014
• Last Updated: April 21, 2016

Record last verified: 2016-03

Locations

AU (3); GB (1); IT (1); DE (1); FR (1)