Osteoarthritis, HipNCT00699088
A Clinical Investigation of the Balance® Microplasty™ Hip System
An observational study of Osteoarthritis, Hip and Rheumatoid Arthritis, run by Biomet Orthopedics, LLC at 4 sites in United States.
Trial summary
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Balance® Microplasty™ Hip System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Rheumatoid Arthritis, Avascular Necrosis
- How many people
- 70 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2005to Mar 2013
- 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 requiring relief from painful or disabling joint disease
Who may be able to join
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 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 femoral head resurfacing component
Who cannot join
- Absolute contraindications include:
- infection,
- sepsis,
- osteomyelitis.
- Relative contraindications include:
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
Show all 12Show fewer
- osteoporosis,
- metabolic disorders which may impair bone formation,
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Chicago
Chicago, Illinois, 60640
Orthopedic Specialty Clinic
Fredericksburg, Virginia, 22401
Orthopaedic & Sports Medicine Clinic of Monroe
Monroe, Wisconsin, 53566
Allegheny Health- Orthopedic Division
Pittsburgh, Pennsylvania, 15212
About this study
Official title: A Prospective, Non-controlled, Clinical Investigation of the Balance® Microplasty™ Hip System
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Balance® Microplasty™ Hip System.
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, Minimally Invasive, Microplasty
- Medical subject headings
- Osteoarthritis, Hip, Arthritis, Rheumatoid, 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 |
|---|---|---|
| Balance® Microplasty™ 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: 5 years
Secondary outcomes (1)
Incidence of revisions and removals
Measured: 5 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 startJan 2005
- Primary completionMar 2013
- Study completionMar 2013
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
- 70 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, Director, Clinical Research, Biomet Orthopedics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699088
- Sponsor's protocol ID
- Biomet 13594-117
- 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 Balance® Microplasty™ Hip System
- ClinicalTrials.gov ID
- NCT00699088
- Acronym / sponsor ID
- Biomet 13594-117
- Keywords
- Total Hip Arthroplasty, Total Hip Replacement, Minimally Invasive, Microplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (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 Balance® Microplasty™ Hip System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balance® Microplasty™ Hip System | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring relief from painful or disabling joint disease
Key inclusion criteria (5 listed)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 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 femoral head resurfacing component
Key exclusion criteria (12 listed)
- infection,
- sepsis,
- osteomyelitis.
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- osteoporosis,
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: 5 years
1 secondary outcome
Incidence of revisions and removals
Time frame: 5 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
Related trials for Osteoarthritis, Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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
Director, Clinical Research, Biomet Orthopedics, LLC
4 sites 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 Rheumatoid Arthritis, run by Biomet Orthopedics, LLC at 4 sites 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 12 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 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 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.