Dynamic Congruence Total Knee Replacement vs Posterior-stabilized

Study Overview
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Brief Summary
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This study compares and evaluates differences in movement analysis, patient-reported outcome between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen with posterior stabilization and Bioimplanti K-Mod cruciate-retaining with dynamic congruence

Detailed Description
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The aim of this study is to assess and compare kinematic and time-space gait parameters in patients after total knee arthroplasty, who will undergo the surgery with the use of either posterior-stabilized (PS) or dynamic congruence (DC) implants. Materials and methods To this study 56 consecutive patients undergoing total knee arthroplasty will be recruited. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization [1:1]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career. Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity and VAS (Visual Analogue Scale). After the surgery 1 to 3 years postoperatively three-dimensional gait analysis will performed with use of BTS SMART device. This device uses passive markers technology and registers the movement by six cameras. To perform full gait analysis several data concerning patients anthropometry will be collected (lower limb length, knee and ankle joint width, width and depth of the pelvis). Whole gait analysis will be performed by experienced single clinical biomechanist accordingly to the Davis protocol. Markers will be installed on the patients' limbs on the following points: base of sacral bone, greater trochanter of the femur, lateral femoral condyle, head of the fibula, lateral malleoli, head of the V metatarsal bone). Participants will walk barefoot for 10 meters quadruple times. Following time-space and kinematic parameters will be assessed: Time-space parameters Single stance time (T1) [%] Swing time (T2) [%] Double-stance time (T3) [%] Step length (SL) [m] Mean gait velocity (Vm) [m/s] Cadence (C) [number of steps/min] Kinematic parameters: Operated knee range of flexion during swing phase [°]

Official Title
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Does Dynamic Congruence Design Improve Gait After Total Knee Replacement in Comparison to Posterior-stabilized One? - Prospective Randomized Controlled Trial

Conditions
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Osteo Arthritis Knee, Surgery, Joint Diseases

Intervention / Treatment
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* Procedure: Total knee replacement
* Diagnostic Test: Biomechanics
* Device: NexGen Ps or Bioimplanti K-MOD implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: agreement to participate in the study BMI (kg/m2) less than 40 ability to walk for 10 meters knee flexion more or equal of 90 degrees Exclusion Criteria: unwillingness to participate in the study osteoarthritis due to the rheumatological disease disorders associated with nerve-muscle signal transmission neurological disorders associated with dizziness, nystagmus or other conditions that might influence balance during activity
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NexGen<br>Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis | Procedure: Total knee replacement<br>* Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior-stabilized or retaining cruciate-retaining with dynamic congruence implant<br>Diagnostic Test: Biomechanics<br>* Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively<br>Device: NexGen Ps or Bioimplanti K-MOD implant<br>* Participant are randomly allocated to receive one of the NexGen PS or Biomplanti K-MOD total knee implant for treatment of end-stage knee osteoarthritis.<br>|
| Active Comparator: K-Mod<br>Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Bioimplanti K-MOD prosthesis | Procedure: Total knee replacement<br>* Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior-stabilized or retaining cruciate-retaining with dynamic congruence implant<br>Diagnostic Test: Biomechanics<br>* Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively<br>Device: NexGen Ps or Bioimplanti K-MOD implant<br>* Participant are randomly allocated to receive one of the NexGen PS or Biomplanti K-MOD total knee implant for treatment of end-stage knee osteoarthritis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of swing phase | Change from baseline part of swing phase time during gait, measured in percentage Change from baseline part of swing phase time during gait, measured in percentage | Time Frame: 1-3 years after surgery | 
| Time of stance phase | Change from baseline part of stance phase time during gait, measured in percentage | Time Frame: 1-3 years after surgery | 
| Time of double-stance phase | Change from baseline part of double-stance phase time during gait, measured in percentage | Time Frame: 1-3 years after surgery | 
| Stride length | Change from baseline length of stride during gait, measured in meters | Time Frame: 1-3 years after surgery | 
| Cadence | Change from baseline number of strides per minute of walking | Time Frame: 1-3 years after surgery | 
| Mean gait velocity | Change from baseline mean values of gait speed, measured in meters per second | Time Frame: 1-3 years after surgery | 
| Range of maximal hip extension for both limbs during ending part of mid-stance phase | Change from baseline range of maximal hip extension for both limbs during ending part of mid-stance phase, measured in degrees | Time Frame: 1-3 years after surgery | 
| Range of pelvic drop in frontal plane on the opposite site of the bearing limb | Change from baseline range of pelvic drop in frontal plane on the opposite site of the bearing limb, measured in degrees | Time Frame: 1-3 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, knee, congruence, posterior-stabilized, cruciate-retaining