N/A
Completed N=112
Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation
Osteoarthritis of Knee
Source: ClinicalTrials.gov NCT02579174 ↗
Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Post-Operative Hip-Knee-Angle (HKA) — 2.14; 3.06 Degrees
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-Operative Hip-Knee-Angle (HKA) |
2.14; 3.06 | — |
| SECONDARY Tibial Varus Deformity |
1.00; 1.38 | — |
| SECONDARY Femoral Valgus Deformity |
1.53; 1.76 | — |
| SECONDARY Tibial Posterior Slope (Mean Deviation) |
2.70; 2.43 | — |
Eligibility Criteria
Inclusion Criteria
- Radiographically confirmed diagnosis of osteoarthritis (OA)
- Failure of non-operative treatment for the diagnosis of symptomatic osteoarthritis
- Age greater than 18 years
- Desire to proceed with elective TKR
- Completion of informed consent and signature of written consent form
Exclusion Criteria
- Ligamentous instability that may necessitate a constrained TKR implant
- Retained hardware in the distal femur or proximal tibia of the operative extremity
- Medical contraindication to undergo preoperative CT, or inability to tolerate preoperative CT
Data sourced from ClinicalTrials.gov (NCT02579174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.