N/A
Completed N=32
Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique
Source: ClinicalTrials.gov NCT03148379 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: OR Total Time — 93.00; 92.72 minutes
Summary
To compare economic factors and the rate of adverse events between two types of instrumentation used for total knee replacement: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical Technique
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY OR Total Time |
93.00; 92.72 | — |
| PRIMARY Opening Instruments |
8.23; 7.42 | — |
| PRIMARY Back Table Setup Time |
21.33; 21.62 | — |
| PRIMARY Tourniquet Time |
58.75; 58.25 | — |
| PRIMARY Incision to Skin Closure |
55.37; 55.03 | — |
| PRIMARY Bone Prep Time |
17.83; 17.67 | — |
| PRIMARY Patella Resection Time |
2.27; 2.22 | — |
| PRIMARY Clean-up Time |
7.67; 8.40 | — |
| SECONDARY Hemoglobin Range |
13.3; 13.3 | — |
| SECONDARY Surgical Waste Weight |
29.8; 21.1 | — |
| SECONDARY Mechanical Axis |
78.4; 72.6 | — |
| SECONDARY Tibial Slope |
4.3; 4.2 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 75 years
- BMI ≤35
- Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA)
- Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Exclusion Criteria
- Pregnant women or those seeking to become pregnant. Pregnancy test is administered prior to surgery as part of routine care by the hospital / surgery center for all female patients of childbearing potential
- Is participating in another clinical study
- Has inflammatory arthritis
- Has knee avascular necrosis
- Has severe deformity, defined as greater than 10 degrees varus or valgus relative to the mechanical axis
- Has retained hardware in the knee that requires removal or interferes with Total Knee Arthroplasty (TKA) procedure
Data sourced from ClinicalTrials.gov (NCT03148379). 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.