Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment
KneeKG Sphere
2 other identifiers
interventional
104
1 country
1
Brief Summary
Total knee arthroplasty (TKA) is a treatment for advanced femoro-tibial osteoarthritis. This surgery is justified in case of significant discomfort and failure of medical treatment. The functional results of TKA are good with a recovery of 6 months - 1 year. Nevertheless, very few patients forget their prostheses. A United Kingdom study assessed patient satisfaction in a cohort of 10,000 patients more than one year after TKA: nearly 20% were not satisfied with their TKA. The knee is indeed a complex articulation that works differently in the three space plans. Current knee prostheses are trying to replicate this biomechanics and get as close as possible to the anatomy of a native knee. Bellemans et al. found in 250 asymptomatic patients 32% of men with a constitutional varus greater than 3 ° and 17% of women. Restoration of normal knee function can also be achieved by restoring a moderate constitutional deformity present preoperatively. The objective of the femorotibial alignment was dogmatically fixed at 180° (mechanical femorotibial alignment). In recent years, some surgical teams have attempted to reproduce the preoperative constitutional deformity in varus or valgus with the prosthesis. This femorotibial alignment is called kinematic alignment. This kinematic alignment has already been studied in several randomized studies and has demonstrated improved functional scores. However, these studies focused on specific TKA, which are posterior cruciate TKA, and the assessment was subjective through functional scores. In addition, these TKA were often made with patient specific instrumentation (PSI). Some studies have evaluated walking kinematics after TKA with kinematic alignment. But it was again TKA retaining the posterior cruciate ligament. The investigators would like to prospectively evaluate the restoration of the medially stabilized TKA walking kinematics (medial-stable TKA or ball in socket stability) implanted with a kinematic alignment compared to a mechanical alignment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedStudy Start
First participant enrolled
September 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2029
ExpectedAugust 23, 2022
August 1, 2022
4.5 years
January 9, 2020
August 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of short terms walking speed.
Comparison between the 2 arms, of the walking speed variation between the evaluation before surgery and 1 year after total knee arthroplasty
12 months
Secondary Outcomes (12)
femorotibial angle in frontal plan
12 months
sagittal femorotibial angle
12 months
tibia rotation compared to the femur
12 months
maximal knee flexion
12 months
maximal knee extension
12 months
- +7 more secondary outcomes
Study Arms (2)
total knee arthroplasty with a kinetic alignment
EXPERIMENTALtotal knee arthroplasty with a mechanical alignment
ACTIVE COMPARATORInterventions
During surgery, a SPHERE prosthesis will replace the knee and the femorotibial alignment. it will be set to reproduce the preoperative constitutional deformity in varus or valgus as it was measured before surgery
During surgery, a SPHERE prosthesis will replace the knee and the femorotibial alignment. It will be set to 180° as defined for a mechanical femorotibial alignment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital de la Croix Rousse
Lyon, 69004, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastien Lustig, Pr
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2020
First Posted
January 13, 2020
Study Start
September 7, 2020
Primary Completion
March 7, 2025
Study Completion (Estimated)
March 7, 2029
Last Updated
August 23, 2022
Record last verified: 2022-08