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Comparison Between Two Operational Techniques for Total Knee Replacement

Primary Purpose

Gait, Unsteady, Knee Arthropathy, Surgery

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
REHAGAIT ANYLIZER
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gait, Unsteady focused on measuring total knee replacement, gait analysis, PROMS, mechanical aligment, kinematic alignment

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • haemek MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mechanically aligned TKR

Kinematically aligned TKR

Arm Description

patients were operated using the standard mechanically aligned technique

patients were operated using the newer mechanically aligned technique

Outcomes

Primary Outcome Measures

PROMS
The patients will fill out functionala and quality of life assessment questionnaires
Gait analysis
The patients will perform a gait analysis using the REHAGAIT system.

Secondary Outcome Measures

Full Information

First Posted
June 18, 2018
Last Updated
February 11, 2020
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT03605290
Brief Title
Comparison Between Two Operational Techniques for Total Knee Replacement
Official Title
Comparison Between Two Operational Techniques for Total Knee Replacement: A Prospective, Case Control, Double Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Unsteady, Knee Arthropathy, Surgery
Keywords
total knee replacement, gait analysis, PROMS, mechanical aligment, kinematic alignment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The operative technique (Kinematic Vs. Mechanically aligned) is not revealed to the patient, investigator and outcomes assessor.
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mechanically aligned TKR
Arm Type
Active Comparator
Arm Description
patients were operated using the standard mechanically aligned technique
Arm Title
Kinematically aligned TKR
Arm Type
Experimental
Arm Description
patients were operated using the newer mechanically aligned technique
Intervention Type
Diagnostic Test
Intervention Name(s)
REHAGAIT ANYLIZER
Intervention Description
Gait analysis instrumentation
Primary Outcome Measure Information:
Title
PROMS
Description
The patients will fill out functionala and quality of life assessment questionnaires
Time Frame
At least 6 months post operatively
Title
Gait analysis
Description
The patients will perform a gait analysis using the REHAGAIT system.
Time Frame
At least 6 months post operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
haemek MC
City
Afula
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparison Between Two Operational Techniques for Total Knee Replacement

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