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

NCT00894140 | Completed

• 1 other identifier: CT01/27
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Osteoarthritis

Keywords

Hip; Cementless; Conservative

Outcome Measures

Primary Outcomes (1)

• 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.

  1year post-surgery

Secondary Outcomes (15)

• Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening

  1 year

• Difference demonstrated between pre-op and 5 year Harris Hip Score

  5 years post surgery

• Difference demonstrated between pre-op and 5 year Oxford Hip Score

  5years post surgery

• Incidence of radiological signs on the post-operative x-rays

  3 months post surgery

• Difference demonstrated between pre-op and 10 year Harris Hip Score

  10 years post surgery

Study Arms (1)

DePuy Silent™ Hip femoral prosthesis

OTHER

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

You may qualify if:

• Male or female subjects, aged between 25 and 65 years inclusive.
• Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
• 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.
• Subjects with non-inflammatory osteoarthritis of the hip who require a primary total hip replacement.

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 have participated in a clinical study with an investigational product in the last 6 month(s).
• Subjects who are currently involved in any injury litigation claims.
• Subjects who have osteonecrosis of the femoral neck
• 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).
• Subjects who are greater than 90kg in weight.
• Subject who have a CCD angle of the anatomical femur less than 125˚
• 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.
• 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
• Subjects who still plan in the future to have children.

Sponsors & Collaborators

• DePuy International: lead
• Johnson and Johnson Medical: collaborator

Study Sites (2)

Sydney Adventist Hospital

Sydney, Australia

Location

General Hospital Eilbek

Hamburg, Germany

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Tammy ODell, BS

  DePuy International

  STUDY CHAIR

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: May 5, 2009
• First Posted: May 6, 2009
• Study Start: January 1, 2003
• Primary Completion: November 1, 2004
• Study Completion: May 1, 2014
• Last Updated: September 26, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (1)