Comparison Between Two Operational Techniques for Total Knee Replacement: A Prospective, Case Control, Double Blinded Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- PROMS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The operative technique (Kinematic Vs. Mechanically aligned) is not revealed to the patient, investigator and outcomes assessor.
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mechanically aligned TKR
patients were operated using the standard mechanically aligned technique
Intervention: REHAGAIT ANYLIZER (Diagnostic Test)
Kinematically aligned TKR
patients were operated using the newer mechanically aligned technique
Intervention: REHAGAIT ANYLIZER (Diagnostic Test)
Outcomes
Primary Outcomes
PROMS
Time Frame: At least 6 months post operatively
The patients will fill out functionala and quality of life assessment questionnaires
Gait analysis
Time Frame: At least 6 months post operatively
The patients will perform a gait analysis using the REHAGAIT system.
Secondary Outcomes
No secondary outcomes reported
Investigators
Uriel Giwnewer
Principal investigator
HaEmek Medical Center, Israel