Osteo Arthritis of the KneePhase 4NCT07646158
Alignment Techniques in TKA RCT
A Phase 4 study testing Technology-assisted inverse kinematic alignment TKA and Manual-instrumented gap balancing alignment TKA in people with Osteo Arthritis of the Knee and Obesity & Overweight, run by Jacob M. Elkins.
Trial summary
The purpose of this research study is to compare two different methods used to align the knee during a total knee arthroplasty (TKA): technology-assisted inverse kinematic alignment, and manual-instrumented gap balancing alignment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteo Arthritis of the Knee, Obesity & Overweight
- What is being tested?
- Technology-assisted inverse kinematic alignment TKA and Manual-instrumented gap balancing alignment TKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being an adult (age >= 18 years)
- Being indicated for Total Knee Arthroplasty (TKA) for the treatment of non-inflammatory knee osteoarthritis by the PI or sub-investigators.
- Having a body mass index (BMI) >= 35 kg/m2
Who cannot join
- Patients who are unable to provide written consent
- Being under-age (age < 18 years)
- Having a BMI < 35 kg/m2
- Having a non-elective TKA
- Having a diagnosis of secondary or inflammatory, rheumatic, psoriatic, osteoarthritis of the index knee
- Having a local or widespread infection
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- Being pregnant - Women who become pregnant at any point throughout the research study will become excluded/ineligible and will immediately stop all study activities.
- Women who are capable of becoming pregnant and not currently on contraceptives will be excluded from this study because it will be difficult to obtain the weightbearing CT using the standard CT shield for pregnant women.
- Having had a previous open surgery of the index knee
- Presence of local or widespread infection
- Having a revision TKA
- Having a simultaneous bilateral TKA
- Not being able to safely conduct study procedures - If patients are wheelchair bound or require an assistive device to stand for 5 minutes, they will be excluded from this study.
- Non-English speakers
- Prisoners
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigating Alignment Techniques in Total Knee Arthroplasty for Morbid Obese Patients: Randomize Control Trial.
The purpose of this research study is to compare two different methods used to align the knee during a total knee arthroplasty (TKA): technology-assisted inverse kinematic alignment, and manual-instrumented gap balancing alignment. The first technique uses robotic or computer-assisted technology to help the surgeon place the knee implant based on the patient's individual anatomy, whereas the manual technique uses standard surgical instruments and manual methods to position and balance the knee implant during surgery. The main difference is that one approach uses robotic or computer assistance to help guide implant positioning, while the other uses traditional instruments and manual surgical techniques. Both methods are commonly used and are considered standard care. The goal of this study is to understand whether one method results in better knee motion, function, and recovery after surgery in patients with higher body weight.
- Conditions
- Osteo Arthritis of the Knee, Obesity & Overweight
- Being tested
- Technology-assisted inverse kinematic alignment TKA, Manual-instrumented gap balancing alignment TKA
- Keywords
- Osteoarthritis, Obesity
- Medical subject headings
- Obesity, Overweight, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-assisted inverse kinematic alignment TKAProcedure or surgery
This technique uses robotic or computer-assisted technology to help the surgeon place the knee implant based on the patient's individual anatomy.
Manual-instrumented gap balancing alignment TKAProcedure or surgery
This manual technique uses standard surgical instruments and manual methods to position and balance the knee implant during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Technology-assisted inverse kinematic alignment | Active comparator | Not described Receives: Procedure: Technology-assisted inverse kinematic alignment TKA |
| Manual-instrumented gap balancing alignment | Active comparator | Not described Receives: Procedure: Manual-instrumented gap balancing alignment TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Measured: From enrollment to the end of follow-up at 1 year after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacob M. Elkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacob M. Elkins, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646158
- Sponsor's protocol ID
- 202510443
- Status last verified
- May 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will be using the OpenCap motion capture system to collect gait data of participants. These recordings are stored in the OpenCap server and thus are shared with the OpenCap developers. Participants can request the removal of these recordings.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Alignment Techniques in Total Knee Arthroplasty for Morbid Obese Patients: Randomize Control Trial.
- ClinicalTrials.gov ID
- NCT07646158
- Acronym / sponsor ID
- 202510443
- Conditions
- Osteo Arthritis of the Knee, Obesity & Overweight
- Keywords
- Osteoarthritis, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jacob M. ElkinsUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jun 2026 (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 purpose of this research study is to compare two different methods used to align the knee during a total knee arthroplasty (TKA): technology-assisted inverse kinematic alignment, and manual-instrumented gap balancing alignment. The first technique uses robotic or computer-assisted technology to help the surgeon place the knee implant based on the patient's individual anatomy, whereas the manual technique uses standard surgical instruments and manual methods to position and balance the knee implant during surgery. The main difference is that one approach uses robotic or computer assistance to help guide implant positioning, while the other uses traditional instruments and manual surgical techniques. Both methods are commonly used and are considered standard care. The goal of this study is to understand whether one method results in better knee motion, function, and recovery after surgery in patients with higher body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-assisted inverse kinematic alignment | Active comparator | Procedure: Technology-assisted inverse kinematic alignment TKA |
| Manual-instrumented gap balancing alignment | Active comparator | Procedure: Manual-instrumented gap balancing alignment TKA |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being an adult (age >= 18 years)
- Being indicated for Total Knee Arthroplasty (TKA) for the treatment of non-inflammatory knee osteoarthritis by the PI or sub-investigators.
- Having a body mass index (BMI) >= 35 kg/m2
Key exclusion criteria (15 listed)
- Patients who are unable to provide written consent
- Being under-age (age < 18 years)
- Having a BMI < 35 kg/m2
- Having a non-elective TKA
- Having a diagnosis of secondary or inflammatory, rheumatic, psoriatic, osteoarthritis of the index knee
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 |
|---|---|---|
| Technology-assisted inverse kinematic alignment TKAThis technique uses robotic or computer-assisted technology to help the surgeon place the knee implant based on the patient's individual anatomy. | Procedure or surgery | Technology-assisted inverse kinematic alignment |
| Manual-instrumented gap balancing alignment TKAThis manual technique uses standard surgical instruments and manual methods to position and balance the knee implant during surgery. | Procedure or surgery | Manual-instrumented gap balancing alignment |
Primary outcome
Range of motion
Time frame: From enrollment to the end of follow-up at 1 year after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes. This study will be using the OpenCap motion capture system to collect gait data of participants. These recordings are stored in the OpenCap server and thus are shared with the OpenCap developers. Participants can request the removal of these recordings.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Technology-assisted inverse kinematic alignment TKA and Manual-instrumented gap balancing alignment TKA in people with Osteo Arthritis of the Knee and Obesity & Overweight, run by Jacob M. Elkins.
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 3 inclusion and 15 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: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Elkins, MD, PHD (+1 319 335 7529, jacob-elkins@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: From enrollment to the end of follow-up at 1 year after intervention.). 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 12 Jun 2026.