Improving knee surgery outcomes by aligning implants with the healthy knee
Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty
This study is testing if aligning knee implants based on the healthy knee instead of the damaged one can help people recover better after knee surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 21 Years to 89 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT06617338 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if using the alignment of the non-arthritic knee for total knee arthroplasty (TKA) leads to better postoperative results compared to the traditional method of aligning based on the arthritic knee. Patients undergoing robotic-assisted TKA will be divided into two groups: one will have their implant alignment based on the healthy contralateral knee, while the other will follow the standard approach. The study will assess the differences in implant positioning and overall function post-surgery. Preoperative CT imaging will guide the alignment for the experimental group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-89 with osteoarthritis in one knee and a non-arthritic contralateral knee.
Not a fit: Patients with conditions other than osteoarthritis or those with a history of significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved alignment and function for patients undergoing knee replacement surgery.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving surgical outcomes through alternative alignment techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient age is 21-89 at time of surgery 2. Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis 3. Patient's contralateral knee is non-arthritic 4. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document 5. Patient is able to read and speak English. Exclusion Criteria: 1. Patient is under the age of 21 2. Patient's primary diagnosis is not osteoarthritis 3. Patient is unable to read and speak English 4. History of previous DVT/PE 5. History of stroke, CABG, or A fib 6. Current smoker
Where this trial is running
Louisville, Kentucky
- UofL Health — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Langan S Smith, BS
- Email: langan.smith@uoflhealth.org
- Phone: 5025878222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.