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

Osteoarthritis Clinical Trial

Official title:

A Non-comparative, Two Centre, EN540, RSA, Pilot Study to Evaluate the Stability, Efficacy and Safety of the Silent Hip Prosthesis in Primary Total Hip Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894140
• Other study ID #: CT01/27
• Status: Completed
• Phase: N/A
• First received: May 5, 2009
• Last updated: September 23, 2016
• Start date: January 2003
• Est. completion date: May 2014

Study information

• Verified date: September 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Amt für Gesundheit und Verbraucherschutz Referat Medizinprodukte
• Study type: Interventional

Clinical Trial 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.

Description:

The Primary Objective of this study was to evaluate the short-term stability of the Silent Hip, implanted using a manual or navigated technique, using radiostereometric analysis (RSA). The study was also intended to provide the clinical data necessary to demonstrate conformance with the essential requirements of the Medical Device Directive. Secondary objectives were to determine the efficacy of the Silent™ Hip femoral prosthesis from a clinical and radiological prospective, to assess the safety of the device and to evaluate the impact of the procedure on the Subjects' Quality of Life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2014
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects, aged between 25 and 65 years inclusive.

2. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

3. 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.

4. Subjects with non-inflammatory osteoarthritis of the hip who require a primary total hip replacement.

Exclusion Criteria:

1. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

2. Women who are pregnant.

3. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

4. Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

5. Subjects who are currently involved in any injury litigation claims.

6. Subjects who have osteonecrosis of the femoral neck

7. 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).

8. Subjects who are greater than 90kg in weight.

9. Subject who have a CCD angle of the anatomical femur less than 125°

10. 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.

11. Subjects with a Charnley C classification.

12. Subjects with an active local or systemic infection.

13. Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the arthroplasty procedure unjustified.

14. Subjects with Paget's disease

15. Subjects who still plan in the future to have children.

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	Sydney Adventist Hospital	Sydney
Germany	General Hospital Eilbek	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
DePuy International	Johnson and Johnson Medical

Countries where clinical trial is conducted

Australia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening		1 year	Yes
Secondary	Difference demonstrated between pre-op and 5 year Harris Hip Score		5 years post surgery	No
Secondary	Difference demonstrated between pre-op and 5 year Oxford Hip Score		5years post surgery	No
Secondary	Incidence of radiological signs on the post-operative x-rays		3 months post surgery	No
Secondary	Difference demonstrated between pre-op and 10 year Harris Hip Score		10 years post surgery	No
Secondary	Difference demonstrated between pre-op and 10 year Oxford Hip Score		10 years post surgery	No
Secondary	Incidence of radiological signs on the post-operative x-rays		6 months post surgery	No
Secondary	Incidence of radiological signs on the post-operative x-rays		1 year post surgery	No
Secondary	Incidence of radiological signs on the post-operative x-rays		18 months post surgery	No
Secondary	Incidence of radiological signs on the post-operative x-rays		2 years post surgery	No
Secondary	Incidence of radiological signs on the post-operative x-rays		5 years post surgery	No
Secondary	Incidence of radiological signs on the post-operative x-rays		10 years post surgery	No
Secondary	Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening		2 years	Yes
Secondary	Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening		5 years	Yes
Secondary	Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening		10 years	Yes