OsteoarthritisNCT00894140
Study to Assess the Stability, Efficacy and Safety of the Silent™ Hip Prosthesis in Primary Total Hip Replacement
A study testing DePuy Silent™ Hip femoral prosthesis in people with Osteoarthritis, run by DePuy International at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- DePuy Silent™ Hip femoral prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2003to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the detailed 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.
- Conditions
- Osteoarthritis
- Being tested
- DePuy Silent™ Hip femoral prosthesis
- Keywords
- Hip, Cementless, Conservative
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DePuy Silent™ Hip femoral prosthesisDevice
A short cementless, femoral component for use in total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| DePuy Silent™ Hip femoral prosthesis | Other | A short cementless, femoral component for use in total hip arthroplasty Receives: Device: DePuy Silent™ Hip femoral prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1year post-surgery
Secondary outcomes (15)
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Measured: 1 year
Difference demonstrated between pre-op and 5 year Harris Hip Score
Measured: 5 years post surgery
Difference demonstrated between pre-op and 5 year Oxford Hip Score
Measured: 5years post surgery
Incidence of radiological signs on the post-operative x-rays
Measured: 3 months post surgery
Difference demonstrated between pre-op and 10 year Harris Hip Score
Measured: 10 years post surgery
Difference demonstrated between pre-op and 10 year Oxford Hip Score
Measured: 10 years post surgery
Incidence of radiological signs on the post-operative x-rays
Measured: 6 months post surgery
Incidence of radiological signs on the post-operative x-rays
Measured: 1 year post surgery
Incidence of radiological signs on the post-operative x-rays
Measured: 18 months post surgery
Incidence of radiological signs on the post-operative x-rays
Measured: 2 years post surgery
Incidence of radiological signs on the post-operative x-rays
Measured: 5 years post surgery
Incidence of radiological signs on the post-operative x-rays
Measured: 10 years post surgery
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Measured: 2 years
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Measured: 5 years
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startJan 2003
- Primary completionNov 2004
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson K.K. Medical Company
- Responsible party
- Sponsor
- Investigators
- Tammy ODell, BS, Study chair, DePuy International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894140
- Sponsor's protocol ID
- CT01/27
- Status last verified
- Sep 2016
- First submitted
- 5 May 2009
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00894140
- Acronym / sponsor ID
- CT01/27
- Conditions
- Osteoarthritis
- Keywords
- Hip, Cementless, Conservative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson K.K. Medical Company
- Study start
- Jan 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DePuy Silent™ Hip femoral prosthesis | Other | Device: DePuy Silent™ Hip femoral prosthesisA short cementless, femoral component for use in total hip arthroplasty |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DePuy Silent™ Hip femoral prosthesisA short cementless, femoral component for use in total hip arthroplasty | Device | DePuy Silent™ Hip femoral prosthesis |
Primary outcome
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.
Time frame: 1year post-surgery
15 secondary outcomes
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Time frame: 1 year
Difference demonstrated between pre-op and 5 year Harris Hip Score
Time frame: 5 years post surgery
Difference demonstrated between pre-op and 5 year Oxford Hip Score
Time frame: 5years post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 3 months post surgery
Difference demonstrated between pre-op and 10 year Harris Hip Score
Time frame: 10 years post surgery
Difference demonstrated between pre-op and 10 year Oxford Hip Score
Time frame: 10 years post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 6 months post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 1 year post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 18 months post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 2 years post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 5 years post surgery
Incidence of radiological signs on the post-operative x-rays
Time frame: 10 years post surgery
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Time frame: 2 years
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Time frame: 5 years
Kaplan Meier survivorship of the Silent Hip prosthesis in terms of revision and radiological aseptic loosening
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tammy ODell, BS study chair
DePuy International
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DePuy Silent™ Hip femoral prosthesis in people with Osteoarthritis, run by DePuy International at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.