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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00878046




Registration number
NCT00878046
Ethics application status
Date submitted
7/04/2009
Date registered
8/04/2009
Date last updated
21/04/2016

Titles & IDs
Public title
Multi-centre Study to Assess Long-term Safety and Efficacy of the Silent™ Hip Prosthesis in Primary THR
Scientific title
A Non-comparative, Multi-centre Study to Evaluate the Safety and Efficacy of the DePuy Silent™ Hip Prosthesis in Primary Total Hip Replacement
Secondary ID [1] 0 0
CT05/01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - DePuy Silent™ Hip femoral prosthesis

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


Treatment: Devices: DePuy Silent™ Hip femoral prosthesis
A short cementless, femoral component for use in total hip arthroplasty
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of complications
Timepoint [1] 0 0
6mths post-surgery
Primary outcome [2] 0 0
Harris Hip score change at 6mths post-surgery
Timepoint [2] 0 0
6mths post-surgery
Secondary outcome [1] 0 0
Harris Hip Score
Timepoint [1] 0 0
3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Secondary outcome [2] 0 0
Oxford Hip Score
Timepoint [2] 0 0
3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Secondary outcome [3] 0 0
UCLA Activity Rating
Timepoint [3] 0 0
3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Secondary outcome [4] 0 0
Incidence of post operative radiological signs
Timepoint [4] 0 0
7 days, 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
Secondary outcome [5] 0 0
Change in bone mineral density
Timepoint [5] 0 0
7days, 3mths, 6mths, 1yr and 2yrs post-surgery
Secondary outcome [6] 0 0
Kaplan-Meier Survivorship Calculations
Timepoint [6] 0 0
3 months, 6 months, and Annually

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Newcastle Hospital - Broadmeadow
Recruitment hospital [2] 0 0
Prince of Wales Private Hospital - Sydney
Recruitment hospital [3] 0 0
Sydney Adventist Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Broadmeadow
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Garches
Country [2] 0 0
Germany
State/province [2] 0 0
Frankfurt
Country [3] 0 0
Italy
State/province [3] 0 0
Jesi
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Cardiff

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
DePuy International
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Johnson & Johnson
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00878046
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00878046