OsteoarthritisNCT00578994
A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System
An observational study of Osteoarthritis and Avascular Necrosis, run by Biomet Orthopedics, LLC at 6 sites in United States.
Trial summary
The purpose of this study is to collect information on complications and survivorship of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis
- What is being tested?
- Oxford® Meniscal Unicompartmental Knee System
- Type of treatment
- Medical device
- How many people
- 388 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2006to 31 Mar 2021
- 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: A Multi-center study conducted in the United States of patients who meet the FDA approved indications for use. The Oxford Meniscal Unicompartmental Knee System is intended for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and is intended to be implanted with bone cement.
Who may be able to join
- Patients with one of the following diagnoses in the medial compartment of the knee: Osteoarthritis, Avascular Necrosis
Who cannot join
- Patients with Rheumatoid arthritis or other forms of inflammatory joint disease
- Patients with infection, sepsis, and osteomyelitis
- Patients with Osteoporosis, Paget's Disease, Charcot's disease, Osteomalacia, and Severe Osteoporosis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Texas Orthopedic Specialist
Bedford, Texas, 76021
Mid-South Orthopedic Associates
Cordova, Tennessee, 38018
Joint Implant Surgeons
New Albany, Ohio, 43054
Texas Center for Joint Replacement
Plano, Texas, 75093
Advanced Orthopaedic Centers
Richmond, Virginia, 23294
Barrington Orthopedic Specialissts
Schaumburg, Illinois, 60195
About this study
Official title: A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System
The purpose of this study is to collect information on complications and survivorship of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.
Read the detailed description
Study Objective
To provide a prospective 2-year post-operative evaluation of complications and 9-year long-term survivorship analysis of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.
Study Design
The study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study:
- A complications study where patients will be followed for at least 2 years to record all complications that may occur, and
- A survival study that will record at yearly intervals out to 9 years whether or not the device is still in place or if it has been removed for any reason.
Phase 1 requires clinical follow-up (0-2 year) and patients will be evaluated at pre-defined intervals up to 2 years post-operative. Information gathered in phase 1 includes all adverse events and survival data.
Phase 2 (3-9 year) only gathers survival data through patient directed mailing and/or phone call.
- Conditions
- Osteoarthritis, Avascular Necrosis
- Being tested
- Oxford® Meniscal Unicompartmental Knee System
- Keywords
- Unicompartmental Knee, Partial Knee, Knee arthroplasty
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford® Meniscal Unicompartmental Knee SystemDevice
Oxford® Meniscal Unicompartmental Knee System is a medial, unicompartmental knee prosthesis containing three components: a femoral component, a tibial component, and a tibial meniscal bearing.
| Study group | Role | What they receive |
|---|---|---|
| Oxford® Meniscal Unicompartmental Knee | Patients with PKA using the Oxford® Meniscal Unicompartmental Knee System Receives: Device: Oxford® Meniscal Unicompartmental Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
Assessment of frequency of Revisions
Measured: Annually for 9 years post-op
Secondary outcomes (1)
Complications
Patients will be followed for at least 2 years to record all complications that may occur
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startMar 2006
- Primary completion31 Dec 2019
- Study completion31 Mar 2021
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
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomet Orthopedics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kacy Arnold, Study director, kacy.arnold@zimmerbiomet.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578994
- Sponsor's protocol ID
- ORTHO.CR.K016
- Other IDs
- P010014
- Status last verified
- Apr 2021
- First submitted
- 19 Dec 2007
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System
- ClinicalTrials.gov ID
- NCT00578994
- Acronym / sponsor ID
- ORTHO.CR.K016
- Conditions
- Osteoarthritis, Avascular Necrosis
- Keywords
- Unicompartmental Knee, Partial Knee, Knee arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 21 Dec 2007 (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 study is to collect information on complications and survivorship of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.
Detailed description
Study Objective
To provide a prospective 2-year post-operative evaluation of complications and 9-year long-term survivorship analysis of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.
Study Design
The study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study:
- A complications study where patients will be followed for at least 2 years to record all complications that may occur, and
- A survival study that will record at yearly intervals out to 9 years whether or not the device is still in place or if it has been removed for any reason.
Phase 1 requires clinical follow-up (0-2 year) and patients will be evaluated at pre-defined intervals up to 2 years post-operative. Information gathered in phase 1 includes all adverse events and survival data.
Phase 2 (3-9 year) only gathers survival data through patient directed mailing and/or phone call.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxford® Meniscal Unicompartmental Knee | – | Device: Oxford® Meniscal Unicompartmental Knee SystemPatients with PKA using the Oxford® Meniscal Unicompartmental Knee System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A Multi-center study conducted in the United States of patients who meet the FDA approved indications for use. The Oxford Meniscal Unicompartmental Knee System is intended for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and is intended to be implanted with bone cement.
Key inclusion criteria (1 listed)
- Patients with one of the following diagnoses in the medial compartment of the knee: Osteoarthritis, Avascular Necrosis
Key exclusion criteria (3 listed)
- Patients with Rheumatoid arthritis or other forms of inflammatory joint disease
- Patients with infection, sepsis, and osteomyelitis
- Patients with Osteoporosis, Paget's Disease, Charcot's disease, Osteomalacia, and Severe Osteoporosis
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 |
|---|---|---|
| Oxford® Meniscal Unicompartmental Knee SystemOxford® Meniscal Unicompartmental Knee System is a medial, unicompartmental knee prosthesis containing three components: a femoral component, a tibial component, and a tibial meniscal bearing. | Device | Oxford® Meniscal Unicompartmental Knee |
Primary outcome
Survivorship
Time frame: Annually for 9 years post-op
Assessment of frequency of Revisions
1 secondary outcome
Complications
Time frame: 2 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 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Kacy Arnold study director
kacy.arnold@zimmerbiomet.com
6 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 and Avascular Necrosis, run by Biomet Orthopedics, LLC at 6 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 1 inclusion and 3 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 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Survivorship (time frame: Annually for 9 years post-op). 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 Apr 2021.