OsteoarthritisNCT00585988
A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty
A study testing Hip Resurfacing System and M2a-Magnum™ Large Metal Articulation in people with Osteoarthritis and Rheumatoid Arthritis, run by Biomet Orthopedics, LLC.
Trial summary
The primary purpose of this study is to compare early functional outcomes in patients undergoing hip resurfacing and total hip arthroplasty with the M2a-Magnum™ using more objective measures of function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Arthritis
- What is being tested?
- Hip Resurfacing System and M2a-Magnum™ Large Metal Articulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Sep 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring hip arthroplasty
Who cannot join
- Patients with sensory, neurological, or general health conditions that alter perception of their limb in space
- Patients with vestibular disorders
About this study
Official title: Functional Recovery Following Hip Resurfacing or Total Hip Arthroplasty in Patients Matched By Age, Gender, and Activity Level
The primary purpose of this study is to compare early functional outcomes in patients undergoing hip resurfacing and total hip arthroplasty with the M2a-Magnum™ using more objective measures of function.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Arthritis, Traumatic Arthritis
- Being tested
- Hip Resurfacing System, M2a-Magnum™ Large Metal Articulation
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip Resurfacing SystemDevice
This arm will utilize a hip resurfacing system.
M2a-Magnum™ Large Metal ArticulationDevice
This arm will utilize the M2a-Magnum™ implant system.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Device: Hip Resurfacing System |
| 2 | Other | Not described Receives: Device: M2a-Magnum™ Large Metal Articulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Tests
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionSep 2009 (estimated)
- Study completionSep 2010 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomet Orthopedics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585988
- Sponsor's protocol ID
- 292-U-010
- Status last verified
- Jun 2017
- First submitted
- 21 Dec 2007
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery Following Hip Resurfacing or Total Hip Arthroplasty in Patients Matched By Age, Gender, and Activity Level
- ClinicalTrials.gov ID
- NCT00585988
- Acronym / sponsor ID
- 292-U-010
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Arthritis, Traumatic Arthritis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 4 Jan 2008 (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 primary purpose of this study is to compare early functional outcomes in patients undergoing hip resurfacing and total hip arthroplasty with the M2a-Magnum™ using more objective measures of function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Hip Resurfacing System |
| 2 | Other | Device: M2a-Magnum™ Large Metal Articulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring hip arthroplasty
Key exclusion criteria (2 listed)
- Patients with sensory, neurological, or general health conditions that alter perception of their limb in space
- Patients with vestibular disorders
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 |
|---|---|---|
| Hip Resurfacing SystemThis arm will utilize a hip resurfacing system. | Device | 1 |
| M2a-Magnum™ Large Metal ArticulationThis arm will utilize the M2a-Magnum™ implant system. | Device | 2 |
Primary outcome
Functional Tests
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Resurfacing System and M2a-Magnum™ Large Metal Articulation in people with Osteoarthritis and Rheumatoid Arthritis, run by Biomet Orthopedics, LLC.
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 2 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: withdrawn, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Functional Tests (time frame: 1 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 21 Jun 2017.