Non-inflammatory Degenerative Joint DiseaseNCT00698503
A Clinical Investigation of the M2a- 38™ Hip System
An observational study of Non-inflammatory Degenerative Joint Disease and Osteoarthritis, 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- 38™ Hip System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a- 38™ Hip System
Who may be able to join
- Patients having primary cemented or cementless total hip replacement for non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnosis of osteoarthritis, avascular necrosis, traumatic arthritis, subcapital fracture, legg perthes, slipped capital epiphysis, fracture of the pelvis, diastrophic variant.
- Patients with full skeletal maturity
- Patients undergoing unilateral total hip arthroplasty or bilateral total hip arthroplasty, either staged or simultaneously
- Patients of all races and gender
- Patients who are able to follow postoperative care instructions
- Patients who are able and willing to return for follow-up evaluations
- Patients have preoperative total Harris Hip Score less than 70 with at least moderate pain.
Who cannot join
- Patients diagnosed with inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematous, pigmented villonodular synovitis, juvenile rheumatoid arthritis and other arthritic processes of inflammatory or autoimmune etiology.
- Patients less than 18 years.
- Patients with the presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.)in the hip joint to be operated.
- Patients with previous Girdlestone procedures.
- Patients with above the knee amputation of the contralateral and/or ipsilateral leg.
- Patients with osteoporosis, or marked bone loss which would preclude proper fixation of the prosthesis.
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- Patients who are pregnant.
- Patients with an active or suspected infection in or around the hip.
- Patients with Parkinson's disease.
- Patients with vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb.
- Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue which would preclude stability of the prosthesis.
- Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).
- Patients unwilling or unable to comply with a rehabilitation program for a cemented or cementless total hip replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
- Patients with previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome, e.g., Paget's disease, Charcot's disease, severe osteoporosis compromising bone stock (Dorr type C bone).
- Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
- Patients with a "fused" hip.
- Patients who have had a total hip arthroplasty on the contralateral hip within the last year.
About this study
Official title: M2a- 38™ Hip System Prospective Data Collection
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- 38™ Hip System
- Keywords
- Metal on Metal, Total Hip Arthroplasty, Total Hip Replacement
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| M2a- 38™ Hip System | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Measured: 12 weeks, 1 year, 3 years, 5 years
Secondary outcomes (1)
Incidence of revisions and removals
Measured: Any time
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 startJan 2002
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: due to low follow up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-inflammatory Degenerative Joint DiseaseStudies 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
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomet Orthopedics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth J Beres, MD, Study director, Director, Clinical Research, Biomet Orthopedics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698503
- Sponsor's protocol ID
- 12380-6
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2008
- Last updated
- 21 Jun 2017
- Results posted
- 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
- M2a- 38™ Hip System Prospective Data Collection
- ClinicalTrials.gov ID
- NCT00698503
- Acronym / sponsor ID
- 12380-6
- Keywords
- Metal on Metal, Total Hip Arthroplasty, Total Hip Replacement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to low follow up
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (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- 38™ Hip System
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M2a- 38™ Hip System | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a- 38™ Hip System
Key inclusion criteria (7 listed)
- Patients having primary cemented or cementless total hip replacement for non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnosis of osteoarthritis, avascular necrosis, traumatic arthritis, subcapital fracture, legg perthes, slipped capital epiphysis, fracture of the pelvis, diastrophic variant.
- Patients with full skeletal maturity
- Patients undergoing unilateral total hip arthroplasty or bilateral total hip arthroplasty, either staged or simultaneously
- Patients of all races and gender
- Patients who are able to follow postoperative care instructions
Key exclusion criteria (17 listed)
- Patients diagnosed with inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematous, pigmented villonodular synovitis, juvenile rheumatoid arthritis and other arthritic processes of inflammatory or autoimmune etiology.
- Patients less than 18 years.
- Patients with the presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.)in the hip joint to be operated.
- Patients with previous Girdlestone procedures.
- Patients with above the knee amputation of the contralateral and/or ipsilateral leg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Harris Hip Score
Time frame: 12 weeks, 1 year, 3 years, 5 years
1 secondary outcome
Incidence of revisions and removals
Time frame: Any time
Results and safety
The study was stopped early (reason given: due to low follow up). 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.
Kenneth J Beres, MD study director
Director, Clinical Research, Biomet Orthopedics, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Non-inflammatory Degenerative Joint Disease and Osteoarthritis, 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 7 inclusion and 17 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: due to low follow up). 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: 12 weeks, 1 year, 3 years, 5 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.