Comparison Between Two Operational Techniques for Total Knee Replacement

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605290
• Other study ID #: 003418EMC
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: February 2020
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Unsteady
• Joint Diseases
• Knee Arthropathy
• Surgery

Intervention

Diagnostic Test:
• REHAGAIT ANYLIZER
Gait analysis instrumentation

Locations

Country	Name	City	State
Israel	haemek MC	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMS	The patients will fill out functionala and quality of life assessment questionnaires	At least 6 months post operatively
Primary	Gait analysis	The patients will perform a gait analysis using the REHAGAIT system.	At least 6 months post operatively