Investigation of robotic-assisted total knee arthroplasty with Skywalker and eMP knee
A Prospective Clinical Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)
This study is testing if using a robotic system for knee surgery with a special implant can help patients recover better and faster compared to traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Orthopaedic Department of General University Hospital of Laria Academic / other |
| Locations | 1 site (Larissa, Thessaly) |
| Trial ID | NCT06969222 on ClinicalTrials.gov |
What this trial studies
This prospective trial aims to evaluate the safety and performance of robotic-assisted total knee arthroplasty (RA-TKA) using the Skywalker system and the Evolution Medial Pivot (eMP) knee implant. The study will include patients who meet specific inclusion and exclusion criteria and will assess various parameters such as surgical time and postoperative recovery. Additionally, it will compare outcomes of eMP patients with Skywalker against those with conventional instrumentation and non-MP TKAs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with noninflammatory degenerative joint disease or functional deformities who can comply with postoperative evaluations.
Not a fit: Patients with poor compliance or those participating in other total hip or knee replacement studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing knee arthroplasty.
How similar studies have performed: Other studies have shown promise in robotic-assisted surgeries, but this specific approach with the Skywalker system and eMP knee is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. \>= 18 Years Male or Female 2. With noninflammatory degenerative joint disease, inflammatory joint disease, functional deformity 3. The subject has signed the Ethical Board approved Informed Consent Form specific to this study prior to enrollment 4. Must be independent, ambulatory, and can comply with all post-operative evaluations and visits. Exclusion Criteria: 1. Subjects with poor compliance, unable to complete the trial according to the requirements or for other reasons or considered not to be suitable for inclusion by investigators. 2. Concurrent participation in any other total hip or knee replacement studies.
Where this trial is running
Larissa, Thessaly
- University Hospital of Larisa — Larissa, Thessaly, Greece (Recruiting)
Study contacts
- Study coordinator: Theofilos Karachalios, MD, PhD, Professor
- Email: kar@med.uth.gr
- Phone: +302413501199
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.