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Completed

NCT Number: NCT04524312

Dynamic Congruence Total Knee Replacement vs Posterior-stabilized

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

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Key information

Conditions

Osteo Arthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 03-984, Poland

About this study

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 [°]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Knee Replacement

Procedure

Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior-stabilized or retaining cruciate-retaining with dynamic congruence implant

Biomechanics

Diagnostic Test

Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively

NexGen Ps or Bioimplanti K-MOD implant

Device

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.

Primary outcomes

  1. Time of swing phase

    Time frame: Time Frame: 1-3 years after surgery

    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

  2. Time of stance phase

    Time frame: Time Frame: 1-3 years after surgery

    Change from baseline part of stance phase time during gait, measured in percentage

  3. Time of double-stance phase

    Time frame: Time Frame: 1-3 years after surgery

    Change from baseline part of double-stance phase time during gait, measured in percentage

  4. Stride length

    Time frame: Time Frame: 1-3 years after surgery

    Change from baseline length of stride during gait, measured in meters

  5. Cadence

    Time frame: Time Frame: 1-3 years after surgery

    Change from baseline number of strides per minute of walking

  6. Mean gait velocity

    Time frame: Time Frame: 1-3 years after surgery

    Change from baseline mean values of gait speed, measured in meters per second

  7. Range of maximal hip extension for both limbs during ending part of mid-stance phase

    Time frame: Time Frame: 1-3 years after surgery

    Change from baseline range of maximal hip extension for both limbs during ending part of mid-stance phase, measured in degrees

  8. Range of pelvic drop in frontal plane on the opposite site of the bearing limb

    Time frame: Time Frame: 1-3 years after surgery

    Change from baseline range of pelvic drop in frontal plane on the opposite site of the bearing limb, measured in degrees

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Acronym: K-Mod

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 24, 2020
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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