Medial Knee Compartment ArthritisNCT01454908
Oxford Partial Knee Kinematics Gait Analysis Study
A study testing Oxford Partial Knee in people with Medial Knee Compartment Arthritis, run by The CORE Institute at 1 site in United States.
Trial summary
The objective of this study is to compare the effect on gait of unicompartmental knee arthroplasty (UKA), using the Oxford Partial Knee, versus normal knee. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medial Knee Compartment Arthritis
- What is being tested?
- Oxford Partial Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2012
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with medial knee compartment arthritis
Who cannot join
- Patients with diagnoses other than osteoarthritis (i.e., rheumatoid arthritis, psoriatic arthritis, etc.)
- Patients with significant diseases of other joints of the lower extremity
- Patients with a diagnosed disorder with gait disturbance (e.g. lower extremity weakness, prior lower extremity arthrodesis, diagnosed movement disorders, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
SHRI-CORE Orthopedic Research Lab
Sun City West, Arizona, 85375
About this study
Official title: Investigation of Unicompartmental Knee Arthroplasty and Functional, Daily Activities: A Quantitative Assessment of Gait, Sit-to-Stand, and Stair Climbing
The objective of this study is to compare the effect on gait of unicompartmental knee arthroplasty (UKA), using the Oxford Partial Knee, versus normal knee.
- Conditions
- Medial Knee Compartment Arthritis
- Being tested
- Oxford Partial Knee
- Keywords
- partial knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford Partial KneeDevice
The Oxford partial knee contains tibial and medial components and a mobile meniscal bearing.
| Study group | Role | What they receive |
|---|---|---|
| Partial Knee Arthroplasty | Other | Oxford Mobile Bearing Unicompartmental Knee Arthroplasties Receives: Device: Oxford Partial Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score (KSS)
Measured: up to 1 month pre-operatively and at 1 year post operatively
Secondary outcomes (1)
Range of Motion (ROM)
Measured: up to 1 month pre-operatively and at 1 year post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startApr 2006
- Primary completionAug 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Knee Compartment ArthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The CORE Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454908
- Sponsor's protocol ID
- 100-U-005
- Status last verified
- Oct 2011
- First submitted
- 13 Oct 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Unicompartmental Knee Arthroplasty and Functional, Daily Activities: A Quantitative Assessment of Gait, Sit-to-Stand, and Stair Climbing
- ClinicalTrials.gov ID
- NCT01454908
- Acronym / sponsor ID
- 100-U-005
- Conditions
- Medial Knee Compartment Arthritis
- Keywords
- partial knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The CORE InstituteUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 19 Oct 2011 (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 objective of this study is to compare the effect on gait of unicompartmental knee arthroplasty (UKA), using the Oxford Partial Knee, versus normal knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial Knee Arthroplasty | Other | Device: Oxford Partial KneeOxford Mobile Bearing Unicompartmental Knee Arthroplasties |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with medial knee compartment arthritis
Key exclusion criteria (3 listed)
- Patients with diagnoses other than osteoarthritis (i.e., rheumatoid arthritis, psoriatic arthritis, etc.)
- Patients with significant diseases of other joints of the lower extremity
- Patients with a diagnosed disorder with gait disturbance (e.g. lower extremity weakness, prior lower extremity arthrodesis, diagnosed movement disorders, etc.).
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 Partial KneeThe Oxford partial knee contains tibial and medial components and a mobile meniscal bearing. | Device | Partial Knee Arthroplasty |
Primary outcome
Knee Society Score (KSS)
Time frame: up to 1 month pre-operatively and at 1 year post operatively
1 secondary outcome
Range of Motion (ROM)
Time frame: up to 1 month pre-operatively and at 1 year post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxford Partial Knee in people with Medial Knee Compartment Arthritis, run by The CORE Institute at 1 site 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: status not confirmed, as of the sponsor's last update on 19 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 (KSS) (time frame: up to 1 month pre-operatively and at 1 year post operatively). 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 19 Oct 2011.