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.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: - over 19 year old - Patients for total knee arthroplasty of both knee - over 5 degree in lateral bowing of femur - having medicare insurance Exclusion Criteria: - Rheumatoid arthritis - Other inflammatory arthritis - Neuropsychiatric patients - Hepatic insufficiency - Renal insufficiency - over 40 of body mass index - Chronic opioid use (taking opioids for longer than 3 months) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| The Catholic University of Korea |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in Range of Motion (ROM) | Changes from Baseline Range of Motion at postoperative 1 year | No | |
| Secondary | Changes in WOMAC (Western Ontario and McMaster University Arthritis Index) | Changes from Baseline score to score of postoperative 1 year | No | |
| Secondary | Changes in Knee Society Score | Changes from Baseline score to score of postoperative 1 year | No | |
| Secondary | Changes in Anterior and posterior stress view on X-ray | Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year | No |