Trial Outcomes & Findings for Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique (NCT NCT03148379)

Results Overview

Total time patient is in operating room

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Day of Surgery

Results posted on

2023-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	21	11
Overall Study COMPLETED	20	11
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.	Total n=32 Participants Total of all reporting groups
Age, Continuous	67.24 years n=21 Participants	65 years n=11 Participants	66.47 years n=32 Participants
Sex: Female, Male Female	6 Participants n=21 Participants	8 Participants n=11 Participants	14 Participants n=32 Participants
Sex: Female, Male Male	15 Participants n=21 Participants	3 Participants n=11 Participants	18 Participants n=32 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	21 participants n=21 Participants	11 participants n=11 Participants	32 participants n=32 Participants

PRIMARY outcome

Timeframe: Day of Surgery

Total time patient is in operating room

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
OR Total Time	93.00 minutes Interval 81.9 to 113.27	92.72 minutes Interval 82.73 to 101.0

PRIMARY outcome

Timeframe: Day of Surgery

Time to open surgical instruments

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Opening Instruments	8.23 minutes Interval 4.2 to 33.5	7.42 minutes Interval 3.7 to 14.0

PRIMARY outcome

Timeframe: Day of Surgery

Time to set up back surgical table

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Back Table Setup Time	21.33 minutes Interval 5.68 to 31.32	21.62 minutes Interval 1.42 to 37.73

PRIMARY outcome

Timeframe: Day of Surgery

Time tourniquet is on patient during surgery

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Tourniquet Time	58.75 minutes Interval 47.43 to 76.48	58.25 minutes Interval 46.07 to 72.13

PRIMARY outcome

Timeframe: Day of Surgery

Time from incision to skin closure during surgery

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Incision to Skin Closure	55.37 minutes Interval 41.77 to 112.92	55.03 minutes Interval 43.57 to 63.87

PRIMARY outcome

Timeframe: Day of Surgery

Time to prepare bone for implant during surgery

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Bone Prep Time	17.83 minutes Interval 12.47 to 32.78	17.67 minutes Interval 9.95 to 17.87

PRIMARY outcome

Timeframe: Day of Surgery

Time to resection patella during surgery

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Patella Resection Time	2.27 minutes Interval 0.83 to 5.93	2.22 minutes Interval 1.18 to 3.32

PRIMARY outcome

Timeframe: Day of Surgery

Time to clean up following surgery

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Clean-up Time	7.67 minutes Interval 1.48 to 20.98	8.40 minutes Interval 1.37 to 24.13

SECONDARY outcome

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

Post op 1 day hemoglobin range

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Hemoglobin Range	13.3 grams per deciliter (g/dl) Interval 8.9 to 18.1	13.3 grams per deciliter (g/dl) Interval 11.5 to 15.8

SECONDARY outcome

Timeframe: Day of Surgery

Weigh surgical waste at the end of each surgery

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Surgical Waste Weight	29.8 pounds Interval 21.0 to 35.3	21.1 pounds Interval 17.6 to 23.9

SECONDARY outcome

Timeframe: Pre-Operative

Radiographic analysis of mechanical axis alignment

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Mechanical Axis	175.5 degrees Interval 165.9 to 186.6	175.85 degrees Interval 168.1 to 184.4

SECONDARY outcome

Timeframe: Post-Operative

Radiographic analysis of mechanical axis alignment

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=20 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Mechanical Axis	78.4 degrees Interval 0.0 to 179.5	72.6 degrees Interval 0.8 to 186.0

SECONDARY outcome

Timeframe: Pre-Operative

Radiographic analysis of Tibial Posterior Slope

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=21 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Tibial Slope	7.6 degrees Interval 2.0 to 12.0	7.6 degrees Interval 3.0 to 12.0

SECONDARY outcome

Timeframe: Post-Operative

Radiographic analysis of Tibial Posterior Slope

Outcome measures

Outcome measures
Measure	Customized Patient Instruments n=20 Participants 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.	Traditional Metal Instruments n=11 Participants 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.
Tibial Slope	4.3 degrees Interval 0.0 to 6.5	4.2 degrees Interval 2.7 to 8.4

Adverse Events

Customized Patient Instruments

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Metal Instruments

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rena Mandino, Director of Clinical Research

Medacta USA

Phone: 352-359-3581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60