N/A
N=82
Comparing Surgical and Economical Parameters of Total Knee Replacement.
Osteo Arthritis Knee · Total Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT03427047 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Compare Time-saving Associated With the Two Procedures. — 25.12; 28.47 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MyKnee with single use Efficiency Instrument (Device); Stryker Navigational with conventional metal instruments (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Medacta USA
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare Time-saving Associated With the Two Procedures. |
25.12; 28.47 | — |
| PRIMARY Patient OR Time From Both Study Arms |
69.83; 70.44; 53.07; 52.84; 10.98; 11.87 | — |
| SECONDARY Estimated Blood Loss From Both Study Arms |
105.43; 100 | — |
| SECONDARY Baseline of Hemoglobin Both Study Arms |
14.18; 13.77; 12.57; 12.31 | — |
| SECONDARY Volume of Transfusions Both Study Arms |
0; 0 | — |
| SECONDARY Instrument Trays Sent to Sterilization Both Study Arms |
5.48; 9.5 | — |
| SECONDARY Amount of Waste From Surgery Both Study Arms |
20196.7; 17653.5 | — |
| SECONDARY Baseline of Mechanical Axis Both Study Arms |
6.05; 5.71; 1.64; 1.24 | — |
| SECONDARY Change From Baseline of Tibial Slope Both Study Arms |
3.80; 2.08; 1.8; 1.87 | — |
| SECONDARY Related Complications |
0; 0 | — |
Summary
Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 75 years 2) BMI ≤35 3) Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA) with the Medacta GMK Sphere 4) Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Exclusion Criteria
- Is participating in another clinical study 2) Has inflammatory arthritis 3) Has knee avascular necrosis 4) Has severe deformity, defined as greater than 15 degrees varus or 10 degrees valgus relative to the mechanical axis. 5) Has retained hardware in the knee that requires removal and interferes with TKA procedure 6) Has prior high tibial osteotomy (HTO)
Data sourced from ClinicalTrials.gov (NCT03427047). 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.