Actively Recruiting
Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment
Led by Hospices Civils de Lyon · Updated on 2022-08-23
104
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the walking patterns after total knee arthroplasty (TKA) in adults aged 55 to 80 with disabling femorotibial osteoarthritis. This study compares two types of knee replacements: one that aligns the knee mechanically at 180 degrees and another that uses kinematic alignment to restore the patient's original knee position. The goal is to understand how these approaches affect knee function and patient satisfaction, as about 20% of patients remain dissatisfied after TKA. The study involves randomly assigning participants to receive either a total knee arthroplasty with kinematic alignment or mechanical alignment. Both surgeries use a SPHERE prosthesis to replace the knee. The kinematic alignment group will have the prosthesis set to mimic their preoperative knee deformity, while the mechanical alignment group will have the prosthesis set to a standard 180-degree alignment. This approach aims to assess the impact of these surgical techniques on knee biomechanics. Participants will be monitored over time, with walking tests and knee function assessments conducted at 12 months and up to 60 months after surgery. Researchers will measure changes in walking speed, knee angles, knee motion, functional recovery, and patient ability to forget the prosthesis. Safety and complications will also be recorded. The study offers thorough follow-up to evaluate long-term outcomes of these knee replacement methods.
CONDITIONS
Brief Title
Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both sexes
- Adults aged 55 to 80 years
- Diagnosis of internal or global disabling femorotibial gonarthrosis
- Indication for first unilateral total knee arthroplasty using a Sphere type prosthesis (Medacta)
- Constitutional varus deformity between 3° and 10°
- Able to support weight on one leg for 1 minute and walk at least 0.8 km/h for 5 minutes
- Affiliated with a social security system
- Able to understand and fulfill study requirements
You will not qualify if you...
- Bilateral total knee arthroplasty
- Revision of a unicompartmental prosthesis
- History of femoral or tibial fracture
- History of femoral or tibial osteotomy
- Additional procedures during surgery (allograft, osteotomy)
- External femorotibial gonarthrosis
- Hip-knee-ankle angle greater than 178°
- Constitutional deformity greater than 10°
- Refusal to participate
- Legal or psychiatric restrictions on participation
- Adults under legal protection measures
- Pregnant or breastfeeding women
- Participation in another clinical trial that may affect this study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo total knee arthroplasty with either kinematic alignment or mechanical alignment using a SPHERE prosthesis.
1 surgical procedure and immediate hospital care
Duration - Up to 60 months
Participants are monitored for recovery, knee function, and complications after surgery.
Regular follow-up visits over 12 months and extended assessments up to 60 months
Trial Site Locations
Total: 1 location
1
Hôpital de la Croix Rousse
Lyon, France, 69004
Actively Recruiting
Research Team
S
Sebastien Lustig, Pr
J
Julien Berthiller
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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