Total Knee Replacement
Conditions
Brief summary
The aim of this study is to evaluate the in vivo kinematics of TKA performed with two different prosthesis: a kinematic retaining (Physica KR) and a posterior-stabilized (Physica PS) design by means of fluoroscopic analysis during activities of daily living (rising from a chair, stairs climbing, leg extension). In comparison with asymptomatic knee. Patterns of femoral rollback will be analyzed to assess if they are motor-task dependent and correlated with clinical outcomes.
Interventions
DEVICEPhysica KR
Kinematic retaining total knee implant
DEVICEPhysica PS
Posterior stabilized total knee implant
Sponsors
Limacorporate S.p.a
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients submitted to Total knee arthroplasty (TKA) with Physica KR or PS; 2. Patients with an appropriate initial fixation and stability of the knee prosthesis; 3. Patients achieving a minimum flexion of 100° or a Knee Society Score (KSS) ≥ 65 (fair/good postoperative outcome) at 6-month follow-up; 4. Patients affected by primary or secondary Osteoarthritis (OA) before surgery; 5. Patients who understand the requirements of the study and are willing and able to comply with activities required for fluoroscopic examination; 6. Patients who have signed the Ethics Committee approved study-specific Informed Consent Form.
Exclusion criteria
1. Patients with misalignment or axial malrotation of the knee prosthesis; 2. Patients not able to achieve a minimum flexion of 100° or with a KSS Knee Score ≤ 65 points at 6-month follow-up; 3. Patients who had or have planned a surgery on their uninvolved knee within a year; 4. Muscular insufficiency or absence of muscololigamentous supporting structures required for adequate soft tissue balance; 5. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation; 6. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device; 7. Any psychiatric illness that would prevent comprehension of the details and nature of the study; 8. Participation in any experimental drug/device study within the 6 months prior to the screening visit 9. Female patients who are pregnant, nursing, or planning a pregnancy due to x-rays exposition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the roll-back mechanism measured with the tibio-femoral contact points at different degrees of flexion | 6 months | Using a software to replicate the movement using Computer-aided design (CAD) models. The movement is studied and the distance made by the femur on the tibia is calculated giving the information of the roll back. |
Countries
Italy
Outcome results
None listed