OsteoarthritisNCT00699270
A Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
An observational study of Osteoarthritis and Avascular Necrosis, run by Biomet Orthopedics, LLC.
Trial summary
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that have already made the decision to undergo shoulder replacement surgery and will receive a Biomet humeral stem.
Who may be able to join
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid Arthritis
- Correction of functional deformity
Who cannot join
- Absolute contraindications:
- Infection, Sepsis, and Osteomyelitis
- Relative contraindications:
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
- Osteoporosis
- Metabolic disorders which may impair bone function
Show all 9Show 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
About this study
Official title: A Prospective, Non-Controlled, Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems
- Keywords
- Total Shoulder Arthroplasty, Total Shoulder Replacement, Shoulder Arthritis
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid, Humeral Fractures
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 |
|---|---|---|
| Biomet Humeral Stems | Biomet Humeral Stems: Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA End Result Score
Measured: 3 months, 6 months, 1 year, 3 years, 5 years
X-rays
Measured: 3 month, 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 startAug 2007
- Primary completionAug 2008
- Study completionDec 2008
Why it stopped: Business need changed.
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 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, Clinical Research, Biomet Orthopedics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699270
- Sponsor's protocol ID
- Biomet 12380-76
- 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 Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
- ClinicalTrials.gov ID
- NCT00699270
- Acronym / sponsor ID
- Biomet 12380-76
- Keywords
- Total Shoulder Arthroplasty, Total Shoulder Replacement, Shoulder Arthritis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business need changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Aug 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 Biomet Humeral Stems
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomet Humeral Stems | – | –Biomet Humeral Stems: Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems |
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 shoulder replacement surgery and will receive a Biomet humeral stem.
Key inclusion criteria (3 listed)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid Arthritis
- Correction of functional deformity
Key exclusion criteria (9 listed)
- Infection, Sepsis, and Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
- Osteoporosis
- Metabolic disorders which may impair bone function
- Osteomalacia
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
UCLA End Result Score
Time frame: 3 months, 6 months, 1 year, 3 years, 5 years
X-rays
Time frame: 3 month, 1 year, 3 years, 5 years
1 secondary outcome
Incidence of revisions and removals
Time frame: Any time
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.
Kenneth J Beres, MD study director
Clinical Research, Biomet Orthopedics, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Avascular Necrosis, 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 3 inclusion and 9 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?
UCLA End Result Score (time frame: 3 months, 6 months, 1 year, 3 years, 5 years). The study lists 2 primary outcomes in all. 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.