Knee Osteoarthritis Clinical Trial
Official title:
Establishing Femoral Component Rotation Using a Dynamic Tensioner Does Not Improve Patellar Position After Total Knee Replacement With Use of Anatomic Implants - Matched-cohort Study
Verified date | May 2023 |
Source | Medical University of Warsaw |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Analysis of patellar positioning in the trochlear groove after TKA with and without the use of dynamic tensioner.
Status | Completed |
Enrollment | 125 |
Est. completion date | August 29, 2021 |
Est. primary completion date | August 29, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 99 Years |
Eligibility | Inclusion Criteria: - age over 60 - BMI < 40 - ablity to walk for 10meters - leg length discrepancy <5mm - knee flexion > 90 degrees - hip extension < 0 degrees - hip flexion > 90 degrees - III / IV level of osteoarthritis in Kellgren - Lawrence scale Exclusion Criteria: - varus/valgus/ fixed flexion deformity > 15 degrees - revision TKA - prior UKA |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Othopedics and Rehabilitation, Medical University of Warsaw | Warsaw | Mazovian |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patella positioning in the trochlear groove on computed tomography (CT) after TKR | Analysis of CT scans of patients undergoing TKR in 30 degrees of knee flexion in the days following the procedure | January 2021 - August 2021 | |
Secondary | Range of motion after TKR | Assessment of range of motion 3 and 12 months after the surgery in the group with standard TKR and dynamic tensioner TKR | January 2021 - January 2022 | |
Secondary | Patient-reported outcome after TKR | Assessment of patient-reported outcome 3 and 12 months after the surgery in the group with standard TKR and dynamic tensioner TKR | January 2021 - January 2022 | |
Secondary | Prevalence of anterior knee pain after TKR | Assessment of the frequency of anterior knee pain 3 and 12 months after the surgery in the group with standard TKR and dynamic tensioner TKR | January 2021 - January 2022 |
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