Single-use Efficiency Instruments With Patient Specific T... | NCT03148379

NCT03148379

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Customized patient instruments	Experimental	Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)	Device: Customized patient instruments
Traditional metal instruments	Active Comparator	Control Group: Patients will undergo conventional surgical technique	Device: Traditional Metal Instruments

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Customized patient instruments	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OR Total Time	Total time patient is in operating room	Day of Surgery
Opening Instruments	Time to open surgical instruments	Day of Surgery
Back Table Setup Time	Time to set up back surgical table	Day of Surgery
Tourniquet Time	Time tourniquet is on patient during surgery	Day of Surgery
Incision to Skin Closure	Time from incision to skin closure during surgery	Day of Surgery
Bone Prep Time	Time to prepare bone for implant during surgery	Day of Surgery
Patella Resection Time	Time to resection patella during surgery	Day of Surgery
Clean-up Time	Time to clean up following surgery	Day of Surgery

Secondary Outcomes

Measure	Description	Time Frame
Hemoglobin Range	Post op 1 day hemoglobin range	24 hours or at discharge if patient does not stay overnight
Surgical Waste Weight	Weigh surgical waste at the end of each surgery

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Mukesh Ahuja, MBBS, MS	Medacta USA	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Tandem Clinical Research, LLC		Marrero	Louisiana	70072	United States
Ortho Montana

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 17, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Customized patient instruments

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00021 BG00111 BG00232

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	OG00093.00(81.90 to 113.27) OG00192.72(82.73 to 101.00)

Primary

Opening Instruments

Time to open surgical instruments

Posted

Mean

Full Range

minutes

Day of Surgery

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Primary

Back Table Setup Time

Time to set up back surgical table

Posted

Mean

Full Range

minutes

Day of Surgery

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Primary

Tourniquet Time

Time tourniquet is on patient during surgery

Posted

Mean

Full Range

minutes

Day of Surgery

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Primary

Incision to Skin Closure

Time from incision to skin closure during surgery

Posted

Mean

Full Range

minutes

Day of Surgery

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Primary

Bone Prep Time

Time to prepare bone for implant during surgery

Posted

Mean

Full Range

minutes

Day of Surgery

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Primary

Patella Resection Time

Time to resection patella during surgery

Posted

Mean

Full Range

minutes

Day of Surgery

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Primary

Clean-up Time

Time to clean up following surgery

Posted

Mean

Full Range

minutes

Day of Surgery

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Hemoglobin Range

Post op 1 day hemoglobin range

Posted

Mean

Full Range

grams per deciliter (g/dl)

24 hours or at discharge if patient does not stay overnight

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Surgical Waste Weight

Weigh surgical waste at the end of each surgery

Posted

Mean

Full Range

pounds

Day of Surgery

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Mechanical Axis

Radiographic analysis of mechanical axis alignment

Posted

Mean

Full Range

degrees

Pre-Operative

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Mechanical Axis

Radiographic analysis of mechanical axis alignment

Posted

Mean

Full Range

degrees

Post-Operative

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Tibial Slope

Radiographic analysis of Tibial Posterior Slope

Posted

Mean

Full Range

degrees

Pre-Operative

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Tibial Slope

Radiographic analysis of Tibial Posterior Slope

Posted

Mean

Full Range

degrees

Post-Operative

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	21	0	21	0	21
EG001	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.	0	11	0	11	0	11

First MCP Posted Date

ID	Term
D010003	Osteoarthritis

BG00266.47(53 to 75)

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases