OsteoarthritisNCT00699257
A Clinical Investigation of the Oxford® Partial Knee System
An observational study of Osteoarthritis, run by Biomet Orthopedics, LLC.
Trial summary
The purpose of this prospective data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to 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 knee surgery and will receive the Oxford® Partial Knee System.
Who may be able to join
- For use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. The implant is intended to be implanted with bone cement.
Who cannot join
- Infection
- Use in the lateral compartment of the knee
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
- Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
- Disease or damage to the lateral compartment of the knee
Show all 17Show fewer
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- 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, neuromuscular disease
- Incomplete or deficient soft tissue surrounding the knee
- Charcot's disease
- A fixed varus deformity (not passively correctable) of greater than 15 degrees
- A flexion deformity greater than 15 degrees
About this study
Official title: A Prospective, Non-controlled, Clinical Investigation of the Oxford® Partial Knee System
The purpose of this prospective data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System.
- Conditions
- Osteoarthritis
- Keywords
- Partial Knee Arthroplasty, Partial Knee Replacement, Arthritis of Medial Compartment of the Knee, Oxford Knee
- Medical subject headings
- Osteoarthritis
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 |
|---|---|---|
| Oxford® Partial Knee System | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
Measured: 6 weeks, 3 months, 1 year, 3 years, 5 years
Oxford-12 Self Assessment Form
Measured: 6 weeks, 3 months, 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 startJul 2004
- Primary completionAug 2008
- Study completionDec 2008
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
- 85 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
- NCT00699257
- Sponsor's protocol ID
- Biomet 12380-63
- 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 Oxford® Partial Knee System
- ClinicalTrials.gov ID
- NCT00699257
- Acronym / sponsor ID
- Biomet 12380-63
- Conditions
- Osteoarthritis
- Keywords
- Partial Knee Arthroplasty, Partial Knee Replacement, Arthritis of Medial Compartment of the Knee, Oxford Knee
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- 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 data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxford® Partial Knee 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 knee surgery and will receive the Oxford® Partial Knee System.
Key inclusion criteria (1 listed)
- For use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. The implant is intended to be implanted with bone cement.
Key exclusion criteria (17 listed)
- Infection
- Use in the lateral compartment of the knee
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
- Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
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
Knee Society Score
Time frame: 6 weeks, 3 months, 1 year, 3 years, 5 years
Oxford-12 Self Assessment Form
Time frame: 6 weeks, 3 months, 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. 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
Clinical Research, Biomet Orthopedics, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 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. 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?
Knee Society Score (time frame: 6 weeks, 3 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.