Dynamic Congruence Total Knee Replacement vs Posterior-stabilized

NCT ID: NCT04524312

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-09-26

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 [°]

Conditions

Osteo Arthritis Knee; Surgery; Joint Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NexGen

Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis

Group Type: ACTIVE_COMPARATOR

Total knee replacement

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

K-Mod

Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Bioimplanti K-MOD prosthesis

Group Type: ACTIVE_COMPARATOR

Total knee replacement

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

Total knee replacement

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

Intervention Type: PROCEDURE

Biomechanics

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

Intervention Type: DIAGNOSTIC_TEST

NexGen Ps or Bioimplanti K-MOD implant

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.

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Artur Stolarczyk

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bartosz M. Maciąg, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Countries

Poland

Other Identifiers

WarsawMU/kmod

Identifier Type: -

Identifier Source: org_study_id