Osteoarthritis, HipNCT01514318
Encore Revelation Hip Stem
An observational study of Osteoarthritis, Hip and Complications; Arthroplasty, run by Encore Medical, L.P. at 1 site in United States.
Trial summary
The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Complications; Arthroplasty
- What is being tested?
- Revelation Hip Stem (Revelation)
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include only subjects who received the Revelation Hip Stem prior to 2002 and who voluntarily consent to take part in this study.
Who may be able to join
- Subjects must have received the Revelation™ Hip Stem as part of a total hip arthroplasty prior to 2002.
- Surgery must have been a primary total hip replacement
- Subject must have received only one primary hip replacement per hospitalization
- Subject must have had a diagnosis of inflammatory tissue disorder, osteoarthritis, post-traumatic arthritis/secondary arthritis or avascular necrosis
- Subject must be willing and able to sign the informed consent document
Who cannot join
- Subject must not have had any previous hip implants (hemi or total joint)
- Subject has a mental condition that may interfere with the ability to give an informed consent (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is a prisoner
- Subject is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Westlake Orthopaedics Spine & Sports
Austin, Texas, 78746
About this study
Official title: A Long-term Follow Up Study of the Revelation™ Hip Stem
The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.
- Conditions
- Osteoarthritis, Hip, Complications; Arthroplasty
- Being tested
- Revelation Hip Stem (Revelation)
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revelation Hip Stem (Revelation)Device
Subjects who received the Revelation Hip Stem prior to 2002 and still maintain the original device.
| Study group | Role | What they receive |
|---|---|---|
| Revelation | Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit. Receives: Device: Revelation Hip Stem (Revelation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of the Device
The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis.
Measured: 10 year
Secondary outcomes (2)
Western Ontario McMaster Arthritis Index (WOMAC)
Standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It assesses the pain, joint stiffness, physical, social \& emotional function of a person with osteoarthritis in determining the overall level of disability. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). For each item, the possible range of scores is therefore 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.
Measured: 10 year
Harris Hip Score
A tool for the evaluation of how a patient is doing after their hip is replaced. Based on a total of 100 points possible, each question is awarded a certain number of points based on how it is answered. Questions are further grouped into four categories. The first category is pain, the second category is function, third is functional activities and finally the physical exam results are tabulated, and based on your range of motion. The score is reported as 90-100 for excellent results, 80-90 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, HipStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DJO Incorporated
- Responsible party
- Sponsor
- Investigators
- Frosty Moore, M.D., Principal investigator, Westlake Orthopaedics Spine & Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514318
- Sponsor's protocol ID
- PS-805
- Status last verified
- Oct 2012
- First submitted
- 22 Dec 2011
- Last updated
- 30 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow Up Study of the Revelation™ Hip Stem
- ClinicalTrials.gov ID
- NCT01514318
- Acronym / sponsor ID
- PS-805
- Conditions
- Osteoarthritis, Hip, Complications; Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Collaborators
- DJO Incorporated
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Posted 30 Nov 2012
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 obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revelation | – | Device: Revelation Hip Stem (Revelation)Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include only subjects who received the Revelation Hip Stem prior to 2002 and who voluntarily consent to take part in this study.
Key inclusion criteria (5 listed)
- Subjects must have received the Revelation™ Hip Stem as part of a total hip arthroplasty prior to 2002.
- Surgery must have been a primary total hip replacement
- Subject must have received only one primary hip replacement per hospitalization
- Subject must have had a diagnosis of inflammatory tissue disorder, osteoarthritis, post-traumatic arthritis/secondary arthritis or avascular necrosis
- Subject must be willing and able to sign the informed consent document
Key exclusion criteria (4 listed)
- Subject must not have had any previous hip implants (hemi or total joint)
- Subject has a mental condition that may interfere with the ability to give an informed consent (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is a prisoner
- Subject is pregnant
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 |
|---|---|---|
| Revelation Hip Stem (Revelation)Subjects who received the Revelation Hip Stem prior to 2002 and still maintain the original device. | Device | Revelation |
Primary outcome
Survivorship of the Device
Time frame: 10 year
The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis.
2 secondary outcomes
Western Ontario McMaster Arthritis Index (WOMAC)
Time frame: 10 year
Harris Hip Score
Time frame: 10 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frosty Moore, M.D. principal investigator
Westlake Orthopaedics Spine & Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and Complications; Arthroplasty, run by Encore Medical, L.P. at 1 site in United States.
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 5 inclusion and 4 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 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 30 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survivorship of the Device (time frame: 10 year). 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 30 Nov 2012.