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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00894140




Registration number
NCT00894140
Ethics application status
Date submitted
5/05/2009
Date registered
6/05/2009

Titles & IDs
Public title
Study to Assess the Stability, Efficacy and Safety of the Silent™ Hip Prosthesis in Primary Total Hip Replacement
Scientific 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
Secondary ID [1] 0 0
CT01/27
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

Other: 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
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.
Timepoint [1] 0 0
1year post-surgery
Secondary outcome [1] 0 0
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Difference demonstrated between pre-op and 5 year Harris Hip Score
Timepoint [2] 0 0
5 years post surgery
Secondary outcome [3] 0 0
Difference demonstrated between pre-op and 5 year Oxford Hip Score
Timepoint [3] 0 0
5years post surgery
Secondary outcome [4] 0 0
Incidence of radiological signs on the post-operative x-rays
Timepoint [4] 0 0
3 months post surgery
Secondary outcome [5] 0 0
Difference demonstrated between pre-op and 10 year Harris Hip Score
Timepoint [5] 0 0
10 years post surgery
Secondary outcome [6] 0 0
Difference demonstrated between pre-op and 10 year Oxford Hip Score
Timepoint [6] 0 0
10 years post surgery
Secondary outcome [7] 0 0
Incidence of radiological signs on the post-operative x-rays
Timepoint [7] 0 0
6 months post surgery
Secondary outcome [8] 0 0
Incidence of radiological signs on the post-operative x-rays
Timepoint [8] 0 0
1 year post surgery
Secondary outcome [9] 0 0
Incidence of radiological signs on the post-operative x-rays
Timepoint [9] 0 0
18 months post surgery
Secondary outcome [10] 0 0
Incidence of radiological signs on the post-operative x-rays
Timepoint [10] 0 0
2 years post surgery
Secondary outcome [11] 0 0
Incidence of radiological signs on the post-operative x-rays
Timepoint [11] 0 0
5 years post surgery
Secondary outcome [12] 0 0
Incidence of radiological signs on the post-operative x-rays
Timepoint [12] 0 0
10 years post surgery
Secondary outcome [13] 0 0
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Timepoint [13] 0 0
2 years
Secondary outcome [14] 0 0
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Timepoint [14] 0 0
5 years
Secondary outcome [15] 0 0
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Timepoint [15] 0 0
10 years

Eligibility
Key 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.
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
NA
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Adventist Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Hamburg

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tammy ODell, BS
Address 0 0
DePuy International
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00894140