Clinical trial NCT04524312: Dynamic Congruence Total Knee Replacement vs Posterior-stabilized
Official title: Does Dynamic Congruence Design Improve Gait After Total Knee Replacement in Comparison to Posterior-stabilized One? - Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Surgery
Joint Diseases
Keywords: osteoarthritis
knee
congruence
posterior-stabilized
cruciate-retaining
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 \[°\]

Eligibility criteria: 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

Primary outcomes:
measure: Time of swing phase
timeFrame: Time Frame: 1-3 years after surgery
measure: Time of stance phase
timeFrame: Time Frame: 1-3 years after surgery
measure: Time of double-stance phase
timeFrame: Time Frame: 1-3 years after surgery
measure: Stride length
timeFrame: Time Frame: 1-3 years after surgery
measure: Cadence
timeFrame: Time Frame: 1-3 years after surgery
measure: Mean gait velocity
timeFrame: Time Frame: 1-3 years after surgery
measure: Range of maximal hip extension for both limbs during ending part of mid-stance phase
timeFrame: Time Frame: 1-3 years after surgery
measure: Range of pelvic drop in frontal plane on the opposite site of the bearing limb
timeFrame: Time Frame: 1-3 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Department of Othopedics and Rehabilitation, Medical University of Warsaw
state: Mazowieckie
Study officials:
affiliation: Medical University of Warsaw
name: Bartosz M. Maciąg, MD
role: PRINCIPAL_INVESTIGATOR
References: