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NCT06617338 · ClinicalTrials.gov registry record · NA
Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty
A NA study of Osteoarthritis (OA) of the Knee, sponsored by University of Louisville.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06617338 is a NA study of Osteoarthritis (OA) of the Knee that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 200 participants, below the 1,389-participant average among 8 other Osteoarthritis (OA) of the Knee trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06617338, a NA study of Osteoarthritis (OA) of the Knee, is actively recruiting participants, sponsored by University of Louisville.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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 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
Conditions Studied
Interventions
- DIAGNOSTIC_TEST CT scan unilateral knee
- DIAGNOSTIC_TEST CT scan bilateral knee
Study Locations (1)
Kentucky
- UofL Health - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-12-12 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06617338
The ClinicalTrials.gov registry entry for NCT06617338 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,389-participant average among 8 other Osteoarthritis (OA) of the Knee trials with a reported enrollment target (86% lower). The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Osteoarthritis (OA) of the Knee appearing as the primary indexed condition, and to 2 interventions - of which CT scan unilateral knee is the first listed.
NCT06617338 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT06617338 about?
NCT06617338 is a clinical study titled "Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty". 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...
What is the current status of trial NCT06617338?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2024-12-12. Estimated completion is 2026-05-31.
What conditions does trial NCT06617338 study?
This clinical trial studies the following conditions: Osteoarthritis (OA) of the Knee.
What interventions are being tested in trial NCT06617338?
The interventions under investigation include: CT scan unilateral knee (DIAGNOSTIC_TEST), CT scan bilateral knee (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06617338?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06617338 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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