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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00878046
Ethics application status
Date submitted
7/04/2009
Date registered
7/04/2009
Date last updated
20/04/2016

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
Gender
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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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/show/NCT00878046