Primary ArthritisNCT01383824
A Multi-centre Study to Assess the Long-term Performance of the Silent Hip™ in Primary Total Hip Replacement Surgery
A study testing Silent™ Hip in people with Primary Arthritis and Secondary Arthritis, run by DePuy International at 9 sites in 5 countries.
Trial summary
The purpose of this study is to monitor the performance and of the Silent Hip™ 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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Primary Arthritis, Secondary Arthritis
- What is being tested?
- Silent™ Hip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Jan 2011to Jul 2015
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any subject deemed suitable to receive the Silent™ Hip in combination with the Pinnacle™ acetabular cup system, in accordance with all applicable Instructions For Use, should be considered for entry into this study.
Who cannot join
- Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Spain3 sites
Hospital Nisa Sevilla-Aljarafe
Seville
Hospital San Juan de Dios del Aljarafe
Seville
Hospital Santa Ángela De La Cruz
Seville
United Kingdom3 sites
Princess Alexandra Hospital
Harlow, Essex
The Rivers Hospital
Sawbridgeworth, Hertfordshire
Wrightington Hospital
Wrightington, Lancashire, WN6 9EP
About this study
Official title: A Multi-centre, Prospective, Uncontrolled Post Market Clinical Follow-up Study (PMCFS) to Monitor the Survival and Performance of the Silent™ Hip in Subjects Requiring a Total Hip Replacement
The purpose of this study is to monitor the performance and of the Silent Hip™ 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.
- Conditions
- Primary Arthritis, Secondary Arthritis
- Being tested
- Silent™ Hip
- Keywords
- Hip Replacement, Femoral Component
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silent™ HipDevice
A short cementless, femoral component for use in total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Silent™ Hip | Other | A short cementless, femoral component for use in total hip arthroplasty Receives: Device: Silent™ Hip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier survivorship
Measured: 5 years post-surgery
Secondary outcomes (57)
Oxford Hip Score
Measured: 6 weeks-6 mths
University of California Los Angeles (UCLA) Activity Score
Measured: 6 weeks-6 mths
EuroQol EQ-5D
Measured: 6 weeks-6 mths
Harris Hip Score
Measured: 6 weeks-6 mths
Radiographic analysis
Measured: pre-discharge
Oxford Hip Score
Measured: 2 years
Oxford Hip Score
Measured: 3 years
Oxford Hip Score
Measured: 4 Years
Oxford Hip Score
Measured: 5 years
Oxford Hip Score
Measured: 6 Years
Oxford Hip Score
Measured: 7 Years
Oxford Hip Score
Measured: 8 Years
Oxford Hip Score
Measured: 9 years
Oxford Hip Score
Measured: 10 Years
Oxford Hip Score
Measured: 11 Years
Oxford Hip Score
Measured: 12 Years
Oxford Hip Score
Measured: 13 Years
Oxford Hip Score
Measured: 14 Years
Oxford Hip Score
Measured: 15 Years
University of California Los Angeles (UCLA) Activity Score
Measured: 2 years
University of California Los Angeles (UCLA) Activity Score
Measured: 3 years
University of California Los Angeles (UCLA) Activity Score
Measured: 4 Years
University of California Los Angeles (UCLA) Activity Score
Measured: 5 Years
University of California Los Angeles (UCLA) Activity Score
Measured: 6 Years
University of California Los Angeles (UCLA) Activity Score
Measured: 7 Years
University of California Los Angeles (UCLA) Activity Score
Measured: 8 Years
University of California Los Angeles (UCLA) Activity Score
Measured: 9 years
University of California Los Angeles (UCLA) Activity Score
Measured: 10 Years
University of California Los Angeles (UCLA) Activity Score
Measured: 11 Years
University of California Los Angeles (UCLA) Activity Score
Measured: 12 Years
University of California Los Angeles (UCLA) Activity Score
Measured: 13 Years
University of California Los Angeles (UCLA) Activity Score
Measured: 14 Years
University of California Los Angeles (UCLA) Activity Score
Measured: 15 years
EuroQol EQ-5D
Measured: 2 Years
EuroQol EQ-5D
Measured: 3 Years
EuroQol EQ-5D
Measured: 4 Years
EuroQol EQ-5D
Measured: 5 Years
EuroQol EQ-5D
Measured: 6 years
EuroQol EQ-5D
Measured: 7 years
EuroQol EQ-5D
Measured: 8 Years
EuroQol EQ-5D
Measured: 9 Years
EuroQol EQ-5D
Measured: 10 Years
EuroQol EQ-5D
Measured: 11 Years
EuroQol EQ-5D
Measured: 12 Years
EuroQol EQ-5D
Measured: 13 Years
EuroQol EQ-5D
Measured: 14 Years
EuroQol EQ-5D
Measured: 15 Years
Harris Hip Score
Measured: 2 Years
Harris Hip Score
Measured: 5 Years
Harris Hip Score
Measured: 10 Years
Harris Hip Score
Measured: 15 Years
Radiographic analysis
Measured: 6 weeks - 6 mths
Radiographic analysis
Measured: 1 year
Radiographic analysis
Measured: 2 Years
Radiographic analysis
Measured: 5 Years
Radiographic analysis
Measured: 10 years
Radiographic analysis
Measured: 15 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completionJul 2015
Why it stopped: Rationalization of the Silent Hip Prosthesis for business reasons only
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ArthritisStudies 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383824
- Sponsor's protocol ID
- CT09/02
- Status last verified
- Aug 2014
- First submitted
- 27 Jun 2011
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective, Uncontrolled Post Market Clinical Follow-up Study (PMCFS) to Monitor the Survival and Performance of the Silent™ Hip in Subjects Requiring a Total Hip Replacement
- ClinicalTrials.gov ID
- NCT01383824
- Acronym / sponsor ID
- CT09/02
- Conditions
- Primary Arthritis, Secondary Arthritis
- Keywords
- Hip Replacement, Femoral Component
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Rationalization of the Silent Hip Prosthesis for business reasons only
- Enrolment
- 89 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Jun 2011 (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 monitor the performance and of the Silent Hip™ 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silent™ Hip | Other | Device: Silent™ HipA short cementless, femoral component for use in total hip arthroplasty |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any subject deemed suitable to receive the Silent™ Hip in combination with the Pinnacle™ acetabular cup system, in accordance with all applicable Instructions For Use, should be considered for entry into this study.
Key exclusion criteria (1 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.
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 |
|---|---|---|
| Silent™ HipA short cementless, femoral component for use in total hip arthroplasty | Device | Silent™ Hip |
Primary outcome
Kaplan-Meier survivorship
Time frame: 5 years post-surgery
57 secondary outcomes
Oxford Hip Score
Time frame: 6 weeks-6 mths
University of California Los Angeles (UCLA) Activity Score
Time frame: 6 weeks-6 mths
EuroQol EQ-5D
Time frame: 6 weeks-6 mths
Harris Hip Score
Time frame: 6 weeks-6 mths
Radiographic analysis
Time frame: pre-discharge
Oxford Hip Score
Time frame: 2 years
Oxford Hip Score
Time frame: 3 years
Oxford Hip Score
Time frame: 4 Years
Oxford Hip Score
Time frame: 5 years
Oxford Hip Score
Time frame: 6 Years
Oxford Hip Score
Time frame: 7 Years
Oxford Hip Score
Time frame: 8 Years
Oxford Hip Score
Time frame: 9 years
Oxford Hip Score
Time frame: 10 Years
Oxford Hip Score
Time frame: 11 Years
Oxford Hip Score
Time frame: 12 Years
Oxford Hip Score
Time frame: 13 Years
Oxford Hip Score
Time frame: 14 Years
Oxford Hip Score
Time frame: 15 Years
University of California Los Angeles (UCLA) Activity Score
Time frame: 2 years
University of California Los Angeles (UCLA) Activity Score
Time frame: 3 years
University of California Los Angeles (UCLA) Activity Score
Time frame: 4 Years
University of California Los Angeles (UCLA) Activity Score
Time frame: 5 Years
University of California Los Angeles (UCLA) Activity Score
Time frame: 6 Years
University of California Los Angeles (UCLA) Activity Score
Time frame: 7 Years
University of California Los Angeles (UCLA) Activity Score
Time frame: 8 Years
University of California Los Angeles (UCLA) Activity Score
Time frame: 9 years
University of California Los Angeles (UCLA) Activity Score
Time frame: 10 Years
University of California Los Angeles (UCLA) Activity Score
Time frame: 11 Years
University of California Los Angeles (UCLA) Activity Score
Time frame: 12 Years
University of California Los Angeles (UCLA) Activity Score
Time frame: 13 Years
University of California Los Angeles (UCLA) Activity Score
Time frame: 14 Years
University of California Los Angeles (UCLA) Activity Score
Time frame: 15 years
EuroQol EQ-5D
Time frame: 2 Years
EuroQol EQ-5D
Time frame: 3 Years
EuroQol EQ-5D
Time frame: 4 Years
EuroQol EQ-5D
Time frame: 5 Years
EuroQol EQ-5D
Time frame: 6 years
EuroQol EQ-5D
Time frame: 7 years
EuroQol EQ-5D
Time frame: 8 Years
Results and safety
The study was stopped early (reason given: Rationalization of the Silent Hip Prosthesis for business reasons only). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silent™ Hip in people with Primary Arthritis and Secondary Arthritis, run by DePuy International at 9 sites in 5 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, United Kingdom, Denmark, Germany, Italy. 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 was stopped early (reason given: Rationalization of the Silent Hip Prosthesis for business reasons only). Results are not available in the source record.
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?
Kaplan-Meier survivorship (time frame: 5 years 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 27 May 2016.