Osteoarthritis, HipNCT00698347
A Clinical Investigation of the M2a-Magnum™ Hip System
An observational study of Osteoarthritis, Hip and Arthritis, run by Biomet Orthopedics, LLC.
Trial summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a-Magnum™ Hip System Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Hip, Arthritis, Rheumatoid Arthritis
- What is being tested?
- M2a-Magnum™ Hip System
- Type of treatment
- Medical device
- How many people
- 249 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Jan 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a-Magnum™ Hip System
Who may be able to join
- Non-inflammatory degenerative joint disease including: Avascular Necrosis, Diastrophic Variant, Fracture of the Pelvis, Fused Hip, Leg Perthes, Osteoarthritis, Slipped Capital Epiphysis, Subcapital Fractures, Traumatic Arthritis
- Rheumatoid Arthritis
- Correction of Functional Deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- Revision of previously failed total hip arthroplasty
Who cannot join
- Absolute contraindications include:
- Infection, Sepsis, and Osteomyelitis
- Relative contraindications include:
- Uncooperative patient or patient with neurologic disorders that are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
Show all 10Show fewer
- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy, or neuromuscular disease
About this study
Official title: A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a-Magnum™ Hip System
Read the detailed description
This is a 10 year prospective data collection documenting the function and survivorship of the M2a-Magnum™ Hip System. Patients are required to come in for preoperative, operative, one year follow-up, three year follow-up, five year follow-up, and ten year follow-up exams.
This product was FDA cleared in 2004.
- Being tested
- M2a-Magnum™ Hip System
- Keywords
- Total Knee Replacement, Total Knee Arthroplasty, Hip Arthritis
- Medical subject headings
- Osteoarthritis, Hip, Arthritis, Arthritis, Rheumatoid, Joint Diseases, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M2a-Magnum™ Hip SystemDevice
Also called Magnum Hip
| Study group | Role | What they receive |
|---|---|---|
| M2a-Magnum™ Hip System | Patients who received the M2a-Magnum™ Hip System Receives: Device: M2a-Magnum™ Hip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Measured: 10 years
Secondary outcomes (2)
Incidence of revisions, removals, and/or complications
Measured: Any time
X-Rays
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 posted17 Jun 2008 (estimated)
- Study startNov 2004
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Centers would not continue follow-up; two centers transitioned patients to a new study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomet Orthopedics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Schenck, PhD, Study director, Clinical Research, Biomet Orthopedics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698347
- Sponsor's protocol ID
- Biomet 12380-82
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2008
- 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
- A Prospective, Non-controlled, Clinical Investigation of the M2a-Magnum™ Hip System
- ClinicalTrials.gov ID
- NCT00698347
- Acronym / sponsor ID
- Biomet 12380-82
- Keywords
- Total Knee Replacement, Total Knee Arthroplasty, Hip Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Centers would not continue follow-up; two centers transitioned patients to a new study.
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Jun 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 purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a-Magnum™ Hip System
Detailed description
This is a 10 year prospective data collection documenting the function and survivorship of the M2a-Magnum™ Hip System. Patients are required to come in for preoperative, operative, one year follow-up, three year follow-up, five year follow-up, and ten year follow-up exams.
This product was FDA cleared in 2004.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M2a-Magnum™ Hip System | – | Device: M2a-Magnum™ Hip SystemPatients who received the M2a-Magnum™ Hip System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a-Magnum™ Hip System
Key inclusion criteria (5 listed)
- Non-inflammatory degenerative joint disease including: Avascular Necrosis, Diastrophic Variant, Fracture of the Pelvis, Fused Hip, Leg Perthes, Osteoarthritis, Slipped Capital Epiphysis, Subcapital Fractures, Traumatic Arthritis
- Rheumatoid Arthritis
- Correction of Functional Deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- Revision of previously failed total hip arthroplasty
Key exclusion criteria (10 listed)
- Infection, Sepsis, and Osteomyelitis
- Uncooperative patient or patient with neurologic disorders that are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
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 |
|---|---|---|
| M2a-Magnum™ Hip SystemAlso: Magnum Hip | Device | M2a-Magnum™ Hip System |
Primary outcome
Harris Hip Score
Time frame: 10 years
2 secondary outcomes
Incidence of revisions, removals, and/or complications
Time frame: Any time
X-Rays
Time frame: 10 years
Results and safety
The study was stopped early (reason given: Centers would not continue follow-up; two centers transitioned patients to a new study.). Results are not available in the source record.
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.
Russell Schenck, PhD study director
Clinical Research, Biomet Orthopedics, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and 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 5 inclusion and 10 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 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 stopped early (reason given: Centers would not continue follow-up; two centers transitioned patients to a new study.). 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?
Harris Hip Score (time frame: 10 years). 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.