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Comparison Between Two Operational Techniques for Total Knee Replacement

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03605290
Enrollment
26
Registered
2018-07-30
Start date
2018-06-15
Completion date
2020-01-01
Last updated
2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait, Unsteady, Knee Arthropathy, Surgery

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTREHAGAIT ANYLIZER

Gait analysis instrumentation

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
PROMSAt least 6 months post operativelyThe patients will fill out functionala and quality of life assessment questionnaires
Gait analysisAt least 6 months post operativelyThe patients will perform a gait analysis using the REHAGAIT system.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026