Comparison Between Two Operational Techniques for Total Knee Replacement

Comparison Between Two Operational Techniques for Total Knee Replacement: A Prospective, Case Control, Double Blinded Study

Advance Knee osteoarthritis is treated by Total knee replacement. Since the first TKR in 1973 there has been continuous advance in implant technology as well as operative technique, yet current patient satisfaction after the procedure is accepted to be about 80%.

There are a few operative techniques to perform TKR. Until recently the most common technique is the anterior approach to the knee and then using mechanical instrumentation to make the bone cuts for the femur and tibia. A second popular technique is the anterior approach to the knee and then using a kinematic alignment to make the bone cuts.

The investigators wish to compare short term results of the two operative techniques as evidenced in patient objective functional scores and also by evaluating the gait of the patients by using the REHAGAIT ANALYZER PRO by HASOMED inc. Magdeburg Germany.

Study Overview

• Status: Completed
• Conditions: Surgery; Knee Arthropathy; Gait, Unsteady
• Intervention / Treatment: Diagnostic test: REHAGAIT ANYLIZER

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • HaEmek MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Patients after total knee replacement which was performed in our ward.

Exclusion Criteria:

• Less than 6 months have passed after the procedure
• Inability to understand and fill out PROMS questionnaires.
• Inability to walk without aids for at least 20 meters.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Mechanically aligned TKR; patients were operated using the standard mechanically aligned technique	Diagnostic test: REHAGAIT ANYLIZER; Gait analysis instrumentation
EXPERIMENTAL: Kinematically aligned TKR; patients were operated using the newer mechanically aligned technique	Diagnostic test: REHAGAIT ANYLIZER; Gait analysis instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMS	The patients will fill out functionala and quality of life assessment questionnaires	At least 6 months post operatively
Gait analysis	The patients will perform a gait analysis using the REHAGAIT system.	At least 6 months post operatively

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2018
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 21, 2018
• First Posted (ACTUAL): July 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: total knee replacement; gait analysis; kinematic alignment; PROMS; mechanical aligment
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Gait Disorders, Neurologic
• Other Study ID Numbers: 003418EMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No