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Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique

A Multi-center, Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed With Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03148379
Enrollment
32
Registered
2017-05-11
Start date
2017-10-11
Completion date
2022-03-30
Last updated
2023-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Total Knee Replacement

Brief 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

Interventions

DEVICECustomized patient instruments

Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.

DEVICETraditional Metal Instruments

Traditional metal instrument will be used to make bone cuts and size the components in this control group.

Sponsors

Medacta USA
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clean-up TimeDay of SurgeryTime to clean up following surgery
Tourniquet TimeDay of SurgeryTime tourniquet is on patient during surgery
Incision to Skin ClosureDay of SurgeryTime from incision to skin closure during surgery
Bone Prep TimeDay of SurgeryTime to prepare bone for implant during surgery
Patella Resection TimeDay of SurgeryTime to resection patella during surgery
OR Total TimeDay of SurgeryTotal time patient is in operating room
Opening InstrumentsDay of SurgeryTime to open surgical instruments
Back Table Setup TimeDay of SurgeryTime to set up back surgical table

Secondary

MeasureTime frameDescription
Surgical Waste WeightDay of SurgeryWeigh surgical waste at the end of each surgery
Mechanical AxisPre-OperativeRadiographic analysis of mechanical axis alignment
Tibial SlopePre-OperativeRadiographic analysis of Tibial Posterior Slope
Hemoglobin Range24 hours or at discharge if patient does not stay overnightPost op 1 day hemoglobin range

Countries

United States

Participant flow

Participants by arm

ArmCount
Customized Patient Instruments
Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks) Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
21
Traditional Metal Instruments
Control Group: Patients will undergo conventional surgical technique Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
11
Total32

Baseline characteristics

CharacteristicTraditional Metal InstrumentsTotalCustomized Patient Instruments
Age, Continuous65 years66.47 years67.24 years
Race and Ethnicity Not Collected—0 Participants—
Region of Enrollment
United States
11 participants32 participants21 participants
Sex: Female, Male
Female
8 Participants14 Participants6 Participants
Sex: Female, Male
Male
3 Participants18 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 11
other
Total, other adverse events
0 / 210 / 11
serious
Total, serious adverse events
0 / 210 / 11

Outcome results

Primary

Back Table Setup Time

Time to set up back surgical table

Time frame: Day of Surgery

ArmMeasureValue (MEAN)
Customized Patient InstrumentsBack Table Setup Time21.33 minutes
Traditional Metal InstrumentsBack Table Setup Time21.62 minutes
Primary

Bone Prep Time

Time to prepare bone for implant during surgery

Time frame: Day of Surgery

ArmMeasureValue (MEAN)
Customized Patient InstrumentsBone Prep Time17.83 minutes
Traditional Metal InstrumentsBone Prep Time17.67 minutes
Primary

Clean-up Time

Time to clean up following surgery

Time frame: Day of Surgery

ArmMeasureValue (MEAN)
Customized Patient InstrumentsClean-up Time7.67 minutes
Traditional Metal InstrumentsClean-up Time8.40 minutes
Primary

Incision to Skin Closure

Time from incision to skin closure during surgery

Time frame: Day of Surgery

ArmMeasureValue (MEAN)
Customized Patient InstrumentsIncision to Skin Closure55.37 minutes
Traditional Metal InstrumentsIncision to Skin Closure55.03 minutes
Primary

Opening Instruments

Time to open surgical instruments

Time frame: Day of Surgery

ArmMeasureValue (MEAN)
Customized Patient InstrumentsOpening Instruments8.23 minutes
Traditional Metal InstrumentsOpening Instruments7.42 minutes
Primary

OR Total Time

Total time patient is in operating room

Time frame: Day of Surgery

ArmMeasureValue (MEAN)
Customized Patient InstrumentsOR Total Time93.00 minutes
Traditional Metal InstrumentsOR Total Time92.72 minutes
Primary

Patella Resection Time

Time to resection patella during surgery

Time frame: Day of Surgery

ArmMeasureValue (MEAN)
Customized Patient InstrumentsPatella Resection Time2.27 minutes
Traditional Metal InstrumentsPatella Resection Time2.22 minutes
Primary

Tourniquet Time

Time tourniquet is on patient during surgery

Time frame: Day of Surgery

ArmMeasureValue (MEAN)
Customized Patient InstrumentsTourniquet Time58.75 minutes
Traditional Metal InstrumentsTourniquet Time58.25 minutes
Secondary

Hemoglobin Range

Post op 1 day hemoglobin range

Time frame: 24 hours or at discharge if patient does not stay overnight

ArmMeasureValue (MEAN)
Customized Patient InstrumentsHemoglobin Range13.3 grams per deciliter (g/dl)
Traditional Metal InstrumentsHemoglobin Range13.3 grams per deciliter (g/dl)
Secondary

Mechanical Axis

Radiographic analysis of mechanical axis alignment

Time frame: Post-Operative

ArmMeasureValue (MEAN)
Customized Patient InstrumentsMechanical Axis78.4 degrees
Traditional Metal InstrumentsMechanical Axis72.6 degrees
Secondary

Mechanical Axis

Radiographic analysis of mechanical axis alignment

Time frame: Pre-Operative

ArmMeasureValue (MEAN)
Customized Patient InstrumentsMechanical Axis175.5 degrees
Traditional Metal InstrumentsMechanical Axis175.85 degrees
Secondary

Surgical Waste Weight

Weigh surgical waste at the end of each surgery

Time frame: Day of Surgery

ArmMeasureValue (MEAN)
Customized Patient InstrumentsSurgical Waste Weight29.8 pounds
Traditional Metal InstrumentsSurgical Waste Weight21.1 pounds
Secondary

Tibial Slope

Radiographic analysis of Tibial Posterior Slope

Time frame: Pre-Operative

ArmMeasureValue (MEAN)
Customized Patient InstrumentsTibial Slope7.6 degrees
Traditional Metal InstrumentsTibial Slope7.6 degrees
Secondary

Tibial Slope

Radiographic analysis of Tibial Posterior Slope

Time frame: Post-Operative

ArmMeasureValue (MEAN)
Customized Patient InstrumentsTibial Slope4.3 degrees
Traditional Metal InstrumentsTibial Slope4.2 degrees

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026