Osteoarthritis, Patient-specific Instruments Clinical Trial
Official title:
Comparison of Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty: A Randomized Controlled Trial
Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving
function. However, in instances where incorrect positioning and malignment of the TKA
components are observed, patients can experience a range of negative postoperative outcomes
such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant
loosening, and eventual early revision. To avoid these complications, achieving a
postoperative alignment within the range of 0°±3° of the mechanical axis is recommended.
Manual intramedullary/extramedullary guides are not thought to be capable of consistently
achieving axes in this range, and though computer-assisted navigation has shown superior
results in comparison with conventional instrumentation, it is also limited by increased
surgical times and no clear superiority in improving short-term clinical outcomes. Thus,
there has been in a push in the orthopaedic community to create more precise technologies to
aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation
(PSI), which uses anatomical data obtained primarily from pre-operative axial computed
tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs
individualized to the patient's unique anatomy, was created with this goal.
This study aims to compare the clinical results of conventional and patient-specific
instruments in total knee arthroplasty.
The objective of this work was to compare pain, stiffness, function and accuracy between
groups at minimum 2 year postoperatively. The investigators hypothesized that PSI would lead
to a neutral mechanical axis on average more frequently than conventional instrumentation.
The study design is a double-blind randomized controlled trial. Randomly, fifty patients
planed to undergo total knee arthroplasty using conventional instruments and other fifty
patients undergo total knee arthroplasty using patient-specific instruments. The clinical
outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And
clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster
University Arthritis Index) pain scale (preoperative and postoperative 6, 12, 24 months),
Knee Society Score (preoperative and postoperative 6, 12, 24 months), Anterior and posterior
stress view on X-ray (preoperative and postoperative 6, 12, 24 months).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment