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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: Recruiting NA study of Osteoarthritis (OA) of the Knee, sponsored by University of Louisville.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Overall Satisfaction with TKA using a Likert scale
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 |
What NCT06617338 shows while recruiting
NCT06617338 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,389-participant average among 8 other Osteoarthritis (OA) of the Knee trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Osteoarthritis (OA) of the Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06617338's enrollment target sits among peer trials
200 4th of 8 higher than 5 of 8 other Osteoarthritis (OA) of the Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis (OA) of the Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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