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Clinical Trials/NCT03605290
NCT03605290
Completed
Not Applicable

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

HaEmek Medical Center, Israel1 site in 1 country26 target enrollmentJune 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gait, Unsteady
Sponsor
HaEmek Medical Center, Israel
Enrollment
26
Locations
1
Primary Endpoint
PROMS
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2018
End Date
January 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Uriel Giwnewer

Principal investigator

HaEmek Medical Center, Israel

Eligibility Criteria

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.

Outcomes

Primary Outcomes

PROMS

Time Frame: At least 6 months post operatively

The patients will fill out functionala and quality of life assessment questionnaires

Gait analysis

Time Frame: At least 6 months post operatively

The patients will perform a gait analysis using the REHAGAIT system.

Study Sites (1)

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