OsteoarthritisNCT02633085
Fixed Bearing Versus Mobile Bearing Patient Satisfaction and Clinical Outcome Study
An observational study of Osteoarthritis, run by Medacta USA at 1 site in United States.
Trial summary
The purpose of this study is to determine if there is a patient satisfaction preference of Fixed Bearing versus Mobile Bearing Unicompartmental Knee Arthroplasty (UKA) in patients who are at a minimum two years post operative. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Fixed Bearing or Mobile Bearing UKA
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 22 Mar 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that have undergone a Unicompartment Knee Replacement with a Fixed Bearing or Mobile Bearing prosthesis.
Who may be able to join
- Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF)
- Ability to understand and provide written authorization for use and disclosure of personal health information.
- Subject who are able and willing to comply with the study protocol and follow-up visit.
- Must be 18 years or older to participate.
- Subjects must have a clinically documented Osteoarthritis in a knee, single or multiple compartments,
- Subjects must have undergone a FB UKA or MB UKA in one and or both knees. MB UKA or FB UKA patients revised to Total Knee Arthroplasty (TKA) are eligible to enroll.
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- Must be a minimum 2 year (24 months) post-surgery on the knee.
- The UKA operation must have been performed by the Investigator.
- Subjects must be able to return for the follow-up appointment, and have the mental capacity to cooperate with PRO's, questionnaires, physical exam and imaging studies.
Who cannot join
- Subjects with Bicompartmental UKA (i.e. medical or lateral UKA combined with Patello Femoral Joint (PFJ) (UKA)
- Women who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tri County Orthopeadic Center
Leesburg, Florida, 34748
About this study
Official title: A Retrospective, Consecutive Series, Single Surgeon Study Comparing Patient Satisfaction and Clinical Outcomes in Patients With Fixed Bearing Versus Mobile Bearing Unicompartmental Knee Arthroplasty
The purpose of this study is to determine if there is a patient satisfaction preference of Fixed Bearing versus Mobile Bearing Unicompartmental Knee Arthroplasty (UKA) in patients who are at a minimum two years post operative. Patient reported outcomes and expectations will be analyzed along with all retrospective chart data in patient with a Fixed Bearing or a Mobile Bearing UKA in one or both knees.
- Conditions
- Osteoarthritis
- Being tested
- Fixed Bearing or Mobile Bearing UKA
- Keywords
- Unicompartment Knee Replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed Bearing or Mobile Bearing UKADevice
Also called Zimmer Unicompartmental High Flex Knee System or Oxford Mobile Bearing
Fixed Bearing or Mobile Bearing UKA Patients who have undergone a primary Fixed Bearing or a Mobile Bearing UKA in either knee and are at a minimum 2 years post-op.
| Study group | Role | What they receive |
|---|---|---|
| Fixed Bearing or Mobile Bearing UKA | Not described Receives: Device: Fixed Bearing or Mobile Bearing UKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare patient satisfaction scores of the Unicompartmental Fixed Bearing (FB) UKA vs Unicompartmental Mobile Bearing (MB) UKA
Utilizing Knee Score Society survey sub-score
Measured: Minimum of two years post-surgery.
Secondary outcomes (9)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee symptoms, pain, function and Qol
Measured: Minimum of two years post-surgery.
Forgotten Joint Score (FJS)
Knee Function-patients ability to forget the artificial joint in everyday life
Measured: Minimum of two years post-surgery.
Knee Society Score (KSS) subjective measures
patient expectation and satisfaction sub-scores
Measured: Minimum of two years post-surgery.
Euro-Qual Health related Quality of Life
General Health Status
Measured: Minimum of two years post-surgery.
Return to Work History
Questionnaire for work history prior to surgery and after surgery
Measured: Minimum of two years post-surgery.
Radiographic Analysis
Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement.
Measured: Minimum of two years post-surgery.
Knee Society Score (KSS) Objective Measures
Measured: Minimum of two years post-surgery.
Demographics
Measured: Minimum of two years post-surgery.
Complications
Complications will be recorded
Measured: Minimum of two years post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Why it stopped: Lack of enrollment
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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mukesh Ahuja, MBBS, MS, Study director, Medacta USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633085
- Sponsor's protocol ID
- #002 FB vs MB
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2015
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Consecutive Series, Single Surgeon Study Comparing Patient Satisfaction and Clinical Outcomes in Patients With Fixed Bearing Versus Mobile Bearing Unicompartmental Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02633085
- Acronym / sponsor ID
- #002 FB vs MB
- Conditions
- Osteoarthritis
- Keywords
- Unicompartment Knee Replacement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 17 Dec 2015 (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 determine if there is a patient satisfaction preference of Fixed Bearing versus Mobile Bearing Unicompartmental Knee Arthroplasty (UKA) in patients who are at a minimum two years post operative. Patient reported outcomes and expectations will be analyzed along with all retrospective chart data in patient with a Fixed Bearing or a Mobile Bearing UKA in one or both knees.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fixed Bearing or Mobile Bearing UKA | – | Device: Fixed Bearing or Mobile Bearing UKA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have undergone a Unicompartment Knee Replacement with a Fixed Bearing or Mobile Bearing prosthesis.
Key inclusion criteria (9 listed)
- Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF)
- Ability to understand and provide written authorization for use and disclosure of personal health information.
- Subject who are able and willing to comply with the study protocol and follow-up visit.
- Must be 18 years or older to participate.
- Subjects must have a clinically documented Osteoarthritis in a knee, single or multiple compartments,
Key exclusion criteria (2 listed)
- Subjects with Bicompartmental UKA (i.e. medical or lateral UKA combined with Patello Femoral Joint (PFJ) (UKA)
- Women who are pregnant.
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 |
|---|---|---|
| Fixed Bearing or Mobile Bearing UKAAlso: Zimmer Unicompartmental High Flex Knee System or Oxford Mobile BearingFixed Bearing or Mobile Bearing UKA Patients who have undergone a primary Fixed Bearing or a Mobile Bearing UKA in either knee and are at a minimum 2 years post-op. | Device | Fixed Bearing or Mobile Bearing UKA |
Primary outcome
To compare patient satisfaction scores of the Unicompartmental Fixed Bearing (FB) UKA vs Unicompartmental Mobile Bearing (MB) UKA
Time frame: Minimum of two years post-surgery.
Utilizing Knee Score Society survey sub-score
9 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Minimum of two years post-surgery.
Forgotten Joint Score (FJS)
Time frame: Minimum of two years post-surgery.
Knee Society Score (KSS) subjective measures
Time frame: Minimum of two years post-surgery.
Euro-Qual Health related Quality of Life
Time frame: Minimum of two years post-surgery.
Return to Work History
Time frame: Minimum of two years post-surgery.
Radiographic Analysis
Time frame: Minimum of two years post-surgery.
Knee Society Score (KSS) Objective Measures
Time frame: Minimum of two years post-surgery.
Demographics
Time frame: Minimum of two years post-surgery.
Complications
Time frame: Minimum of two years post-surgery.
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 24 Mar 2023.
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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.
Mukesh Ahuja, MBBS, MS study director
Medacta USA, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Medacta USA 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 9 inclusion and 2 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 24 Mar 2023. 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?
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?
To compare patient satisfaction scores of the Unicompartmental Fixed Bearing (FB) UKA vs Unicompartmental Mobile Bearing (MB) UKA (time frame: Minimum of two years post-surgery.). 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 24 Mar 2023.