Clinical trial NCT02993016: Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty
Official title: Comparison of Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Patient-specific Instruments
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in Range of Motion (ROM)
timeFrame: Changes from Baseline Range of Motion at postoperative 1 year
Secondary outcomes:
measure: Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)
timeFrame: Changes from Baseline score to score of postoperative 1 year
measure: Changes in Knee Society Score
timeFrame: Changes from Baseline score to score of postoperative 1 year
measure: Changes in Anterior and posterior stress view on X-ray
timeFrame: Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year
Other outcomes:
Locations:
Study officials:
affiliation: the Catholic Univerisity of Korea Seoul St Mary's hospital
name: Yong In, MD, PhD
role: STUDY_CHAIR
References:
citation: ALShammari SA, Choi KY, Koh IJ, Kim MS, In Y. Total knee arthroplasty in femoral bowing: does patient specific instrumentation have something to add? A randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 2;22(1):321. doi: 10.1186/s12891-021-04198-5.