Comparing walking analysis after knee replacement using different alignment methods
Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment
This study is testing which of two knee replacement methods helps people aged 55 to 80 with severe knee arthritis walk better and feel more satisfied after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 55 Years to 80 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT04226339 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the outcomes of total knee arthroplasty (TKA) by comparing two alignment techniques: kinematic alignment and mechanical alignment. The study focuses on patients aged 55 to 80 with disabling knee osteoarthritis who are undergoing their first unilateral TKA. Participants will be assessed for their walking ability and satisfaction post-surgery, aiming to determine which alignment method leads to better functional results and patient satisfaction. The trial is conducted at Hôpital de la Croix Rousse in Lyon.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55 to 80 with disabling femorotibial osteoarthritis and specific constitutional deformities.
Not a fit: Patients who have undergone bilateral TKA or have a history of significant knee surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve patient satisfaction and functional outcomes after knee replacement surgery.
How similar studies have performed: Previous studies have shown varying success with different alignment techniques in knee arthroplasty, but this specific comparison is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Both sex * Adults between 55 and 80 years * Diagnosis of internal or global disabling femorotibial gonarthrosis Indication of total first knee arthroplasty (unilateral), using a Sphere type prosthesis (Medacta) * Constitutional deformity in varus between 3 ° and 10 ° * Fulfilling the pass conditions of a KneeKG walking test: Unipodal support possible for 1 minute, run for 5 min at a speed of at least 0.8 km / h * Affiliated to a social security system * Patients able to understand and fulfill the requirement of the study Exclusion Criteria: * TKA bilateral * TKA to change an Uni-compartmental prosthesis * History of femoral or tibial fracture * History of femoral or tibial osteotomy * Associated gesture at the same time (allograft, osteotomy) * External femorotibial gonarthrosis * Angle Hip Knee Ankle \> 178 ° * Constitutional distortion\> 10 ° * Refusal to participate in the study * Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social institution for purposes other than research * Adults subject to a legal protection measure * breastfeeding or pregnant women * Patient already participating to another clinical trial that might jeopardize the current trial
Where this trial is running
Lyon
- Hôpital de la Croix Rousse — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Sebastien Lustig, Pr — Hospices Civils de Lyon
- Study coordinator: Sebastien Lustig, Pr
- Email: sebastien.lustig@chu-lyon.fr
- Phone: 4 26 10 92 98
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.