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Not yet recruitingNCT07646158Updated Jun 12, 2026

Alignment Techniques in TKA RCT

A Phase 4 interventional study of Technology-assisted inverse kinematic alignment TKA and Manual-instrumented gap balancing alignment TKA in Osteo Arthritis of the Knee and Obesity & Overweight, sponsored by Jacob M. Elkins. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Jacob M. Elkins · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Osteo Arthritis of the Knee
  • Obesity & Overweight

Keywords

  • Osteoarthritis
  • Obesity
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 80 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Jacob M. Elkins is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Technology-assisted inverse kinematic alignment

    Procedure: Technology-assisted inverse kinematic alignment TKA

  • Active comparator
    Manual-instrumented gap balancing alignment

    Procedure: Manual-instrumented gap balancing alignment TKA

Interventions

  • ProcedureTechnology-assisted inverse kinematic alignment TKA

    This technique uses robotic or computer-assisted technology to help the surgeon place the knee implant based on the patient's individual anatomy.

  • ProcedureManual-instrumented gap balancing alignment TKA

    This manual technique uses standard surgical instruments and manual methods to position and balance the knee implant during surgery.

06

What researchers measure

Primary outcomes

  1. Range of motion

    Time frame: From enrollment to the end of follow-up at 1 year after intervention.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07646158
Lead sponsor
Jacob M. Elkins
Responsible party
Jacob M. Elkins (Assistant Professor, University of Iowa) — Sponsor-investigator
First posted
Jun 12, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Jul 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jun 12, 2026

Study contacts

Jacob Elkins, MD, PHD
Contact
jacob-elkins@uiowa.edu
+1 319 335 7529

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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