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Comparison Between Two Operational Techniques for Total Knee Replacement

H

HaEmek Medical Center, Israel

Status

Completed

Conditions

Gait, Unsteady
Surgery
Knee Arthropathy

Treatments

Diagnostic Test: REHAGAIT ANYLIZER

Study type

Interventional

Funder types

Other

Identifiers

NCT03605290
003418EMC

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

26 participants in 2 patient groups

Mechanically aligned TKR
Active Comparator group
Description:
patients were operated using the standard mechanically aligned technique
Treatment:
Diagnostic Test: REHAGAIT ANYLIZER
Kinematically aligned TKR
Experimental group
Description:
patients were operated using the newer mechanically aligned technique
Treatment:
Diagnostic Test: REHAGAIT ANYLIZER

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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