Osteoarthritis (OA) of the KneeNCT06617338
Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty
A study testing CT scan unilateral knee and CT scan bilateral knee in people with Osteoarthritis (OA) of the Knee, run by University of Louisville at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty (TKA) based on the non-arthritic side will give the patient better overall alignment, function, and improved results compared to basing our implant alignment and positioning off the arthritic… Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- CT scan unilateral knee and CT scan bilateral knee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 2 Mar 2026
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age is 21-89 at time of surgery
- Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis
- Patient's contralateral knee is non-arthritic
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- Patient is able to read and speak English.
Who cannot join
- Patient is under the age of 21
- Patient's primary diagnosis is not osteoarthritis
- Patient is unable to read and speak English
- History of previous DVT/PE
- History of stroke, CABG, or A fib
- Current smoker
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty (TKA) based on the non-arthritic side will give the patient better overall alignment, function, and improved results compared to basing our implant alignment and positioning off the arthritic side, which is currently the traditional method.
The main questions it aims to answer are:
Read more
- Will a patient have improved postoperative TKA results if the implant alignment is based off the non-arthritic side compared to the standard arthritic side?
- What are the similarities or differences between study arms with respect to final implant alignment and positioning angles? Researchers will compare the outcomes of two cohorts of patients undergoing primary robotic-assisted total knee arthroplasty (RA-TKA) with normal contralateral knee. Based on preoperative CT imaging, the researchers will use normal contralateral side joint numbers as the target alignment for one group (Experimental arm) and utilize the traditional method for the other group (Active comparator arm). Clinical outcomes and patient-reported outcome measures (PROMs) will be compared between groups.
Participants will:
- Be randomized into one of two study arms and will receive either a unilateral knee CT or bilateral knee CT preoperatively
- Follow-up in the clinic at 2 weeks, 6 weeks and 1-year postoperatively, per standard-of-care for x-ray and clinical evaluation.
- Complete postop questionnaires (PROMs) at the prescribed follow-up intervals
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- CT scan unilateral knee, CT scan bilateral knee
- Keywords
- osteoarthritis, knee, total knee arthroplasty, target alignment
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan unilateral kneeDiagnostic test
Intervention given to the Active Comparator arm
CT scan bilateral kneeDiagnostic test
Intervention given to the Experimental Arm
| Study group | Role | What they receive |
|---|---|---|
| Participant receives bilateral knee CT preoperatively | Experimental | The P.I. (Dr. Malkani) will use normal contralateral side joint numbers as the target alignment for RA-TKA Receives: Diagnostic Test: CT scan bilateral knee |
| Participant receives unilateral CT of the operative knee preoperatively | Active comparator | The P.I. will use the traditional method to obtain target alignment for RA-TKA. Receives: Diagnostic Test: CT scan unilateral knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Satisfaction
Overall Satisfaction with TKA using a Likert scale
Measured: 1-year postoperatively
Pain VAS
Level of knee pain (scale of zero to ten) using the Visual Analog Scale (VAS)
Measured: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
KOOS JR
KOOS JR questionnaire
Measured: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
Forgotten Joint Score
FJS-12 questionnaire
Measured: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
PROMIS-10 Mental and Physical Health scores
PROMIS-10 Global Health questionnaire
Measured: preoperatively and 1-year postoperatively
Incidence of revision TKA
postoperative complication requiring a revision total knee arthroplasty
Measured: 1 year postop
non-revision complication
postoperative complication requiring a non-revision procedure
Measured: 1 year postop
Secondary outcomes (1)
Active ROM
Active knee range of motion: active extension, active flexion
Measured: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start12 Dec 2024
- Primary completion27 Feb 2026
- Study completion2 Mar 2026
Why it stopped: It is not feasible to conduct this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized cohort analysis study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Malkani, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617338
- Sponsor's protocol ID
- 24.0701
- Status last verified
- Mar 2026
- First submitted
- 25 Sep 2024
- Last updated
- 25 Mar 2026
- 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06617338
- Acronym / sponsor ID
- 24.0701
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- osteoarthritis, knee, total knee arthroplasty, target alignment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It is not feasible to conduct this study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 27 Sep 2024 (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.
The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty (TKA) based on the non-arthritic side will give the patient better overall alignment, function, and improved results compared to basing our implant alignment and positioning off the arthritic side, which is currently the traditional method.
The main questions it aims to answer are:
- Will a patient have improved postoperative TKA results if the implant alignment is based off the non-arthritic side compared to the standard arthritic side?
- What are the similarities or differences between study arms with respect to final implant alignment and positioning angles? Researchers will compare the outcomes of two cohorts of patients undergoing primary robotic-assisted total knee arthroplasty (RA-TKA) with normal contralateral knee. Based on preoperative CT imaging, the researchers will use normal contralateral side joint numbers as the target alignment for one group (Experimental arm) and utilize the traditional method for the other group (Active comparator arm). Clinical outcomes and patient-reported outcome measures (PROMs) will be compared between groups.
Participants will:
- Be randomized into one of two study arms and will receive either a unilateral knee CT or bilateral knee CT preoperatively
- Follow-up in the clinic at 2 weeks, 6 weeks and 1-year postoperatively, per standard-of-care for x-ray and clinical evaluation.
- Complete postop questionnaires (PROMs) at the prescribed follow-up intervals
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized cohort analysis study
| Arm | Type | Receives |
|---|---|---|
| Participant receives bilateral knee CT preoperatively | Experimental | Diagnostic Test: CT scan bilateral kneeThe P.I. (Dr. Malkani) will use normal contralateral side joint numbers as the target alignment for RA-TKA |
| Participant receives unilateral CT of the operative knee preoperatively | Active comparator | Diagnostic Test: CT scan unilateral kneeThe P.I. will use the traditional method to obtain target alignment for RA-TKA. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient age is 21-89 at time of surgery
- Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis
- Patient's contralateral knee is non-arthritic
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- Patient is able to read and speak English.
Key exclusion criteria (6 listed)
- Patient is under the age of 21
- Patient's primary diagnosis is not osteoarthritis
- Patient is unable to read and speak English
- History of previous DVT/PE
- History of stroke, CABG, or A fib
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 |
|---|---|---|
| CT scan unilateral kneeIntervention given to the Active Comparator arm | Diagnostic test | Participant receives unilateral CT of the operative knee preoperatively |
| CT scan bilateral kneeIntervention given to the Experimental Arm | Diagnostic test | Participant receives bilateral knee CT preoperatively |
Primary outcome
Overall Satisfaction
Time frame: 1-year postoperatively
Overall Satisfaction with TKA using a Likert scale
Pain VAS
Time frame: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
Level of knee pain (scale of zero to ten) using the Visual Analog Scale (VAS)
KOOS JR
Time frame: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
KOOS JR questionnaire
Forgotten Joint Score
Time frame: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
FJS-12 questionnaire
PROMIS-10 Mental and Physical Health scores
Time frame: preoperatively and 1-year postoperatively
PROMIS-10 Global Health questionnaire
Incidence of revision TKA
Time frame: 1 year postop
postoperative complication requiring a revision total knee arthroplasty
non-revision complication
Time frame: 1 year postop
postoperative complication requiring a non-revision procedure
1 secondary outcome
Active ROM
Time frame: preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively
Results and safety
The study was stopped early (reason given: It is not feasible to conduct this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- 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.
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 CT scan unilateral knee and CT scan bilateral knee in people with Osteoarthritis (OA) of the Knee, run by University of Louisville 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 25 Mar 2026. 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 stopped early (reason given: It is not feasible to conduct 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?
Overall Satisfaction (time frame: 1-year postoperatively). The study lists 7 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 25 Mar 2026.