Comparison Between Two Operational Techniques for Total Knee Replacement

NCT03605290 | Completed DMC

• 1 other identifier: 003418EMC
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait, Unsteady; Knee Arthropathy; Surgery

Keywords

total knee replacement; gait analysis; PROMS; mechanical aligment; kinematic alignment

Outcome Measures

Primary Outcomes (2)

• PROMS

  The patients will fill out functionala and quality of life assessment questionnaires

  At least 6 months post operatively

• Gait analysis

  The patients will perform a gait analysis using the REHAGAIT system.

  At least 6 months post operatively

Study Arms (2)

Mechanically aligned TKR

ACTIVE COMPARATOR

patients were operated using the standard mechanically aligned technique

Diagnostic Test: REHAGAIT ANYLIZER

Kinematically aligned TKR

EXPERIMENTAL

patients were operated using the newer mechanically aligned technique

Diagnostic Test: REHAGAIT ANYLIZER

Interventions

REHAGAIT ANYLIZER DIAGNOSTIC_TEST

Gait analysis instrumentation

Kinematically aligned TKR; Mechanically aligned TKR

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients after total knee replacement which was performed in our ward.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

haemek MC

Afula, Israel

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The operative technique (Kinematic Vs. Mechanically aligned) is not revealed to the patient, investigator and outcomes assessor.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 30, 2018
• Study Start: June 15, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

IL (1)