Osteo Arthritis KneeNCT03385759
Trial of Unicompartmental Versus Total Knee Arthroplasty
A study testing Unicompartmental knee arthroplasty and Total knee arthroplasty in people with Osteo Arthritis Knee, run by Anderson Orthopaedic Research Institute at 2 sites in United States.
Trial summary
This study is a prospective, randomized trial to compare patient outcomes of unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) for the treatment of medial compartment osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Unicompartmental knee arthroplasty and Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 2018to Jan 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medial compartment osteoarthritis of the knee
- knee flexion greater than greater than 90 degrees
- flexion contracture of less than 10 degrees
- varus deformity < 20 degrees
- grade IV degeneration of the medial compartment
Who cannot join
- lateral compartment degenerative changes
- previous lateral meniscectomy
- anterior cruciate ligament deficiency
- body mass index > 40
- inflammatory arthritis
- history of septic arthritis
Show all 11Show fewer
- hemoglobin A1c > 8.0
- chronic liver disease
- stage 3A or greater chronic renal disease
- active IV drug abuse
- patients requiring thromboembolic prophylaxis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22306
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: A Prospective Randomized Trial of Unicompartmental Versus Total Knee Arthroplasty for the Treatment of Medial Compartment Osteoarthritis
This study is a prospective, randomized trial to compare patient outcomes of unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) for the treatment of medial compartment osteoarthritis.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Unicompartmental knee arthroplasty, Total knee arthroplasty
- Keywords
- unicompartmental knee, total knee arthroplasty, osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicompartmental knee arthroplastyProcedure or surgery
Implant to replace the medial compartment of a patient with knee osteoarthritis
Total knee arthroplastyProcedure or surgery
Implant to replace the knee joint of a patient with knee osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| UKA | Active comparator | Medial unicompartmental knee arthroplasty Receives: Procedure: Unicompartmental knee arthroplasty |
| TKA | Active comparator | Total knee arthroplasty Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
Functional outcome questionnaire ranging from 0-100, with 100 being best
Measured: 1 year
Knee Society Score
Functional knee outcome questionnaire ranging from 0-100, with 100 being best
Measured: 2 years
Secondary outcomes (1)
Revision
complication requiring revision surgery
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 posted28 Dec 2017
- Study start22 May 2018
- Primary completion1 Apr 2023 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anderson Orthopaedic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center
- Responsible party
- Principal investigator, Nancy Parks, Anderson Orthopaedic Research Institute
- Investigators
- Kevin Fricka, MD, Principal investigator, Anderson Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385759
- Sponsor's protocol ID
- 17-2931
- Status last verified
- Nov 2022
- First submitted
- 21 Dec 2017
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Unicompartmental Versus Total Knee Arthroplasty for the Treatment of Medial Compartment Osteoarthritis
- ClinicalTrials.gov ID
- NCT03385759
- Acronym / sponsor ID
- 17-2931
- Conditions
- Osteo Arthritis Knee
- Keywords
- unicompartmental knee, total knee arthroplasty, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Anderson Orthopaedic Research InstituteUniversity, hospital or other
- Collaborators
- Rush University Medical Center
- Study start
- 22 May 2018 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 28 Dec 2017 (actual)
- 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.
This study is a prospective, randomized trial to compare patient outcomes of unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) for the treatment of medial compartment osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UKA | Active comparator | Procedure: Unicompartmental knee arthroplastyMedial unicompartmental knee arthroplasty |
| TKA | Active comparator | Procedure: Total knee arthroplastyTotal knee arthroplasty |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- medial compartment osteoarthritis of the knee
- knee flexion greater than greater than 90 degrees
- flexion contracture of less than 10 degrees
- varus deformity < 20 degrees
- grade IV degeneration of the medial compartment
Key exclusion criteria (11 listed)
- lateral compartment degenerative changes
- previous lateral meniscectomy
- anterior cruciate ligament deficiency
- body mass index > 40
- inflammatory arthritis
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 |
|---|---|---|
| Unicompartmental knee arthroplastyImplant to replace the medial compartment of a patient with knee osteoarthritis | Procedure or surgery | UKA |
| Total knee arthroplastyImplant to replace the knee joint of a patient with knee osteoarthritis | Procedure or surgery | TKA |
Primary outcome
Knee Society Score
Time frame: 1 year
Functional outcome questionnaire ranging from 0-100, with 100 being best
Knee Society Score
Time frame: 2 years
Functional knee outcome questionnaire ranging from 0-100, with 100 being best
1 secondary outcome
Revision
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Kevin Fricka, MD principal investigator
Anderson Orthopaedic Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unicompartmental knee arthroplasty and Total knee arthroplasty in people with Osteo Arthritis Knee, run by Anderson Orthopaedic Research Institute at 2 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 5 inclusion and 11 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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: 1 year). 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 14 Nov 2022.