OsteoarthritisNCT02583113
Bilateral Total Knee Arthroplasty vs Unicompartment Arthroplasty Retrospective and Clinical Outcome Study
An observational study of Osteoarthritis, run by Medacta USA at 1 site in United States.
Trial summary
To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis who underwent a primary TKA one side and a primary UKA on the opposite side and are at a minimum of two years post-surgery. 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?
- Total and Unicompartment Knee Replacement
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 1 Dec 2026
- 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 Total Knee and Unicompartment knee replacement contralateral.
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 both knees, single or multiple compartments
- Subjects must have undergone a primary TKA and primary UKA in the contralateral knee
Show all 9Show fewer
- Must be a minimum 2 year (24 months) post-surgery on each knee
- One or both TKA/UKA surgeries must have been performed by the Principal 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 radiographs
Who cannot join
- Subjects who underwent UKA with Patella Femoral Joint (PFJ) replacement on the same side.
- 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 Patient Preference and Clinical Outcomes Study in Bilateral Knee Osteoarthritis Patients With Both Total Knee Arthroplasty and Unicompartment Knee Arthroplasty Prostheses.
To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis who underwent a primary TKA one side and a primary UKA on the opposite side and are at a minimum of two years post-surgery. Patient reported outcomes and data with be analyzed along with all retrospective chart data.
- Conditions
- Osteoarthritis
- Being tested
- Total and Unicompartment Knee Replacement
- Keywords
- Total Knee Replacement, 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.
Total and Unicompartment Knee ReplacementDevice
Also called TKA UKA
Patients who have undergone a primary TKA on one side and primary UKA on the opposite side and are at a minimum of two years post-surgery.
| Study group | Role | What they receive |
|---|---|---|
| Total and Unicompartment Knee Replacement | Not described Receives: Device: Total and Unicompartment Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA)
Asking patients "which is your better knee overall"
Measured: Minimum 2 years post surgery
Secondary outcomes (8)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee symptoms, pain, function, and QoL
Measured: Minimum 2 years post-op
Forgotten Joint Score (FJS)
Knee function-patient's ability to forget the artificial joint in everyday life
Measured: Minimum of 2 years post-op
Knee Society Score (KSS) subjective measures
Patient Expectation and Satisfaction Sub-scores
Measured: Minimum of 2 years post-op
Euro-Qual Health Related Quality of Life (EQ-5D)
General health status
Measured: Minimum of 2 years post-op
Return to work history
Questionnaire for work history prior to surgery and after surgery
Measured: Minimum of 2 years post-op
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: Pre-operative and minimum of 2 years post-op
Knee Society Score (KSS) Objective measures
Measured: Minimum of 2 years post-op
Demographics
Measured: Pre-operative and Minimum of 2 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: Alternate Research Pursued
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
- NCT02583113
- Sponsor's protocol ID
- UNI 001
- Status last verified
- Mar 2023
- First submitted
- 20 Oct 2015
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Consecutive Series Patient Preference and Clinical Outcomes Study in Bilateral Knee Osteoarthritis Patients With Both Total Knee Arthroplasty and Unicompartment Knee Arthroplasty Prostheses.
- ClinicalTrials.gov ID
- NCT02583113
- Acronym / sponsor ID
- UNI 001
- Conditions
- Osteoarthritis
- Keywords
- Total Knee Replacement, Unicompartment Knee Replacement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Alternate Research Pursued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Oct 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.
To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis who underwent a primary TKA one side and a primary UKA on the opposite side and are at a minimum of two years post-surgery. Patient reported outcomes and data with be analyzed along with all retrospective chart data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total and Unicompartment Knee Replacement | – | Device: Total and Unicompartment Knee Replacement |
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 Total Knee and Unicompartment knee replacement contralateral.
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 both knees, single or multiple compartments
Key exclusion criteria (2 listed)
- Subjects who underwent UKA with Patella Femoral Joint (PFJ) replacement on the same side.
- 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 |
|---|---|---|
| Total and Unicompartment Knee ReplacementAlso: TKA UKAPatients who have undergone a primary TKA on one side and primary UKA on the opposite side and are at a minimum of two years post-surgery. | Device | Total and Unicompartment Knee Replacement |
Primary outcome
To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA)
Time frame: Minimum 2 years post surgery
Asking patients "which is your better knee overall"
8 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Minimum 2 years post-op
Forgotten Joint Score (FJS)
Time frame: Minimum of 2 years post-op
Knee Society Score (KSS) subjective measures
Time frame: Minimum of 2 years post-op
Euro-Qual Health Related Quality of Life (EQ-5D)
Time frame: Minimum of 2 years post-op
Return to work history
Time frame: Minimum of 2 years post-op
Radiographic Analysis
Time frame: Pre-operative and minimum of 2 years post-op
Knee Society Score (KSS) Objective measures
Time frame: Minimum of 2 years post-op
Demographics
Time frame: Pre-operative and Minimum of 2 years post-op
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 20 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 20 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 evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) (time frame: Minimum 2 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 20 Mar 2023.