Dynamic Congruence Total Knee Replacement vs Posterior-stabilized

NCT04524312 | Completed

• 1 other identifier: WarsawMU/kmod
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Osteo Arthritis Knee; Surgery; Joint Diseases

Keywords

osteoarthritis; knee; congruence; posterior-stabilized; cruciate-retaining

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

NexGen

ACTIVE COMPARATOR

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

Procedure: Total knee replacement; Diagnostic Test: Biomechanics; Device: NexGen Ps or Bioimplanti K-MOD implant

K-Mod

ACTIVE COMPARATOR

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

Procedure: Total knee replacement; Diagnostic Test: Biomechanics; Device: NexGen Ps or Bioimplanti K-MOD implant

Interventions

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

K-Mod; NexGen

Biomechanics DIAGNOSTIC_TEST

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

K-Mod; NexGen

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.

K-Mod; NexGen

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 03-984, Poland

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee; Biomechanical Phenomena

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Biophysical Phenomena; Physical Phenomena; Mechanical Phenomena

Study Officials

• Bartosz M. Maciąg, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant will not be informed which type of prosthesis was used in their particular case. Outcomes Assessor will not be informed which type of prosthesis was used in particular patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: December 1, 2017
• Primary Completion: September 26, 2020
• Study Completion: September 26, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

PL (1)