Comparison Between Two Operational Techniques for Total Knee Replacement

Not Applicable

Completed

• Conditions: Gait, Unsteady; Knee Arthropathy; Surgery
• Interventions: Diagnostic Test: REHAGAIT ANYLIZER

• Registration Number: NCT03605290
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-15
• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-07-21
• Study First Posted: 2018-07-30
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kinematically aligned TKR	REHAGAIT ANYLIZER	patients were operated using the newer mechanically aligned technique
Mechanically aligned TKR	REHAGAIT ANYLIZER	patients were operated using the standard mechanically aligned technique

Primary Outcome Measures

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

Trial Locations

Locations (1)

haemek MC; 🇮🇱 Afula, Israel