At a glance
ClinicalIndex Comparison RecordN/ACompleted· 112 enrolled
Drug / intervention
Medacta GMK Spheredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation
In Brief
A clinical study evaluating Medacta GMK Sphere for Osteoarthritis of Knee. Completed, enrolled 112 participants across 1 site.
Detailed Summary
1. To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy as computed axial tomography (CT) 2. To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional alignment of Total Knee Replacement implants. 3. To evaluate differences in total knee replacement implant alignment in patients whose arthroplasty is performed using manual or custom instrumentation derived from preoperative CT
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of Knee
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedOct 2015
Primary CompletionSep 2020
Study CompletionNov 2020
TodayJul 2026
First PostedOct 19, 2015
Enrollment StartJan 1, 2015
Primary CompletionSep 8, 2020
Study CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 10.7 years ago
Interventions
Medacta GMK Spheredevice