Comparison Between Two Operational Techniques for Total Knee Replacement

NCT ID: NCT03605290

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2020-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gait, Unsteady Knee Arthropathy Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The operative technique (Kinematic Vs. Mechanically aligned) is not revealed to the patient, investigator and outcomes assessor.

Study Groups

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Mechanically aligned TKR

patients were operated using the standard mechanically aligned technique

Group Type ACTIVE_COMPARATOR

REHAGAIT ANYLIZER

Intervention Type DIAGNOSTIC_TEST

Gait analysis instrumentation

Kinematically aligned TKR

patients were operated using the newer mechanically aligned technique

Group Type EXPERIMENTAL

REHAGAIT ANYLIZER

Intervention Type DIAGNOSTIC_TEST

Gait analysis instrumentation

Interventions

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REHAGAIT ANYLIZER

Gait analysis instrumentation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Uriel Giwnewer

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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haemek MC

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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003418EMC

Identifier Type: -

Identifier Source: org_study_id

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