## Protocol Section
### Identification Module
**NCT ID:** NCT03148379

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

**Official Title:** 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.

#### Organization Study ID Info
**ID:** 20161119
#### Organization
**Class:** INDUSTRY
**Full Name:** Medacta USA
### Status Module
#### Completion Date
**Date:** 2022-03-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-08

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-03-30

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-08-08

**Type:** ACTUAL

**Results First Submit Date:** 2023-06-30

**Results First Submit QC Date:** 2023-08-04

#### Start Date
**Date:** 2017-10-11

**Type:** ACTUAL

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2017-05-11
**Type:** ACTUAL
**Study First Submit Date:** 2017-04-20
**Study First Submit QC Date:** 2017-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Medacta USA

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Osteoarthritis

**Keywords:**

- Total Knee Replacement

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 32

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)

**Intervention Names:**

- Device: Customized patient instruments

**Label:** Customized patient instruments

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Control Group: Patients will undergo conventional surgical technique

**Intervention Names:**

- Device: Traditional Metal Instruments

**Label:** Traditional metal instruments

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Customized patient instruments

**Description:** 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.

**Name:** Customized patient instruments

**Other Names:**

- Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®)

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Traditional metal instruments

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

**Name:** Traditional Metal Instruments

**Other Names:**

- Traditional Metal Instruments with Conventional Surgical Technique

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Total time patient is in operating room

**Measure:** OR Total Time

**Time Frame:** Day of Surgery

**Description:** Time to open surgical instruments

**Measure:** Opening Instruments

**Time Frame:** Day of Surgery

**Description:** Time to set up back surgical table

**Measure:** Back Table Setup Time

**Time Frame:** Day of Surgery

**Description:** Time tourniquet is on patient during surgery

**Measure:** Tourniquet Time

**Time Frame:** Day of Surgery

**Description:** Time from incision to skin closure during surgery

**Measure:** Incision to Skin Closure

**Time Frame:** Day of Surgery

**Description:** Time to prepare bone for implant during surgery

**Measure:** Bone Prep Time

**Time Frame:** Day of Surgery

**Description:** Time to resection patella during surgery

**Measure:** Patella Resection Time

**Time Frame:** Day of Surgery

**Description:** Time to clean up following surgery

**Measure:** Clean-up Time

**Time Frame:** Day of Surgery

#### Secondary Outcomes

**Description:** Post op 1 day hemoglobin range

**Measure:** Hemoglobin Range

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

**Description:** Weigh surgical waste at the end of each surgery

**Measure:** Surgical Waste Weight

**Time Frame:** Day of Surgery

**Description:** Radiographic analysis of mechanical axis alignment

**Measure:** Mechanical Axis

**Time Frame:** Pre-Operative

**Description:** Radiographic analysis of mechanical axis alignment

**Measure:** Mechanical Axis

**Time Frame:** Post-Operative

**Description:** Radiographic analysis of Tibial Posterior Slope

**Measure:** Tibial Slope

**Time Frame:** Pre-Operative

**Description:** Radiographic analysis of Tibial Posterior Slope

**Measure:** Tibial Slope

**Time Frame:** Post-Operative

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Marrero

**Country:** United States

**Facility:** Tandem Clinical Research, LLC

**State:** Louisiana

**Zip:** 70072

**Location 2:**

**City:** Billings

**Country:** United States

**Facility:** Ortho Montana

**State:** Montana

**Zip:** 59101

**Location 3:**

**City:** Meadville

**Country:** United States

**Facility:** Orthopedic Associates Meadville

**State:** Pennsylvania

**Zip:** 16335

**Location 4:**

**City:** Austin

**Country:** United States

**Facility:** Texas Orthopedics

**State:** Texas

**Zip:** 78759

**Location 5:**

**City:** West Jordan

**Country:** United States

**Facility:** Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence

**State:** Utah

**Zip:** 84088

#### Overall Officials

**Official 1:**

**Affiliation:** Medacta USA

**Name:** Mukesh Ahuja, MBBS, MS

**Role:** STUDY_DIRECTOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-05-17

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 493437

- Type Abbrev: Prot_SAP

- Upload Date: 2023-06-30T15:42

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2023-07-25

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Customized Patient Instruments

**Deaths Num At Risk:** 21

**Description:** 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.

**ID:** EG000

**Other Num at Risk:** 21

**Serious Number At Risk:** 21

**Title:** Customized Patient Instruments

**Group ID:** EG001

**Title:** Traditional Metal Instruments

**Deaths Num At Risk:** 11

**Description:** 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.

**ID:** EG001

**Other Num at Risk:** 11

**Serious Number At Risk:** 11

**Title:** Traditional Metal Instruments

**Frequency Threshold:** 0

**Time Frame:** Surgery to 6 weeks post-op

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 11

**Group ID:** BG002

**Value:** 32

**Units:** Participants

### Group

**ID:** BG000

**Title:** Customized Patient Instruments

**Description:** 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.

### Group

**ID:** BG001

**Title:** Traditional Metal Instruments

**Description:** 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.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 56

**Upper Limit:** 75

**Value:** 67.24

#### Measurement

**Group ID:** BG001

**Lower Limit:** 53

**Upper Limit:** 70

**Value:** 65

#### Measurement

**Group ID:** BG002

**Lower Limit:** 53

**Upper Limit:** 75

**Value:** 66.47

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 11

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 18

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 11

**Group ID:** BG002

**Value:** 32

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 32

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 21

**Group ID:** BG001

**Value:** 11

**Group ID:** BG002

**Value:** 32

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Email:** rmandino@medacta.us.com
**Organization:** Medacta USA
**Phone:** 352-359-3581
**Title:** Rena Mandino, Director of Clinical Research
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 81.90
- **Spread:** 
- **Upper Limit:** 113.27
- **Value:** 93.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 82.73
- **Spread:** 
- **Upper Limit:** 101.00
- **Value:** 92.72
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.20
- **Spread:** 
- **Upper Limit:** 33.50
- **Value:** 8.23
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.70
- **Spread:** 
- **Upper Limit:** 14.00
- **Value:** 7.42
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.68
- **Spread:** 
- **Upper Limit:** 31.32
- **Value:** 21.33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.42
- **Spread:** 
- **Upper Limit:** 37.73
- **Value:** 21.62
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 47.43
- **Spread:** 
- **Upper Limit:** 76.48
- **Value:** 58.75
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 46.07
- **Spread:** 
- **Upper Limit:** 72.13
- **Value:** 58.25
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 41.77
- **Spread:** 
- **Upper Limit:** 112.92
- **Value:** 55.37
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 43.57
- **Spread:** 
- **Upper Limit:** 63.87
- **Value:** 55.03
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12.47
- **Spread:** 
- **Upper Limit:** 32.78
- **Value:** 17.83
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 9.95
- **Spread:** 
- **Upper Limit:** 17.87
- **Value:** 17.67
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.83
- **Spread:** 
- **Upper Limit:** 5.93
- **Value:** 2.27
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.18
- **Spread:** 
- **Upper Limit:** 3.32
- **Value:** 2.22
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.48
- **Spread:** 
- **Upper Limit:** 20.98
- **Value:** 7.67
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.37
- **Spread:** 
- **Upper Limit:** 24.13
- **Value:** 8.40
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8.9
- **Spread:** 
- **Upper Limit:** 18.1
- **Value:** 13.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 11.5
- **Spread:** 
- **Upper Limit:** 15.8
- **Value:** 13.3
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 21.0
- **Spread:** 
- **Upper Limit:** 35.3
- **Value:** 29.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 17.6
- **Spread:** 
- **Upper Limit:** 23.9
- **Value:** 21.1
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 165.9
- **Spread:** 
- **Upper Limit:** 186.6
- **Value:** 175.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 168.1
- **Spread:** 
- **Upper Limit:** 184.4
- **Value:** 175.85
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.0
- **Spread:** 
- **Upper Limit:** 179.5
- **Value:** 78.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.8
- **Spread:** 
- **Upper Limit:** 186.0
- **Value:** 72.6
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.0
- **Spread:** 
- **Upper Limit:** 12.0
- **Value:** 7.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.0
- **Spread:** 
- **Upper Limit:** 12.0
- **Value:** 7.6
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.0
- **Spread:** 
- **Upper Limit:** 6.5
- **Value:** 4.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.7
- **Spread:** 
- **Upper Limit:** 8.4
- **Value:** 4.2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Total time patient is in operating room
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** OR Total Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 2
**Description:** Time to open surgical instruments
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Opening Instruments
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 3
**Description:** Time to set up back surgical table
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Back Table Setup Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 4
**Description:** Time tourniquet is on patient during surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Tourniquet Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 5
**Description:** Time from incision to skin closure during surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Incision to Skin Closure
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 6
**Description:** Time to prepare bone for implant during surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Bone Prep Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 7
**Description:** Time to resection patella during surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Patella Resection Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 8
**Description:** Time to clean up following surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Clean-up Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 9
**Description:** Post op 1 day hemoglobin range
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 24 hours or at discharge if patient does not stay overnight
**Title:** Hemoglobin Range
**Type:** SECONDARY
**Unit of Measure:** grams per deciliter (g/dl)
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 10
**Description:** Weigh surgical waste at the end of each surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Surgical Waste Weight
**Type:** SECONDARY
**Unit of Measure:** pounds
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 11
**Description:** Radiographic analysis of mechanical axis alignment
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Pre-Operative
**Title:** Mechanical Axis
**Type:** SECONDARY
**Unit of Measure:** degrees
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 12
**Description:** Radiographic analysis of mechanical axis alignment
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Post-Operative
**Title:** Mechanical Axis
**Type:** SECONDARY
**Unit of Measure:** degrees
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 13
**Description:** Radiographic analysis of Tibial Posterior Slope
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Pre-Operative
**Title:** Tibial Slope
**Type:** SECONDARY
**Unit of Measure:** degrees
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 14
**Description:** Radiographic analysis of Tibial Posterior Slope
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Post-Operative
**Title:** Tibial Slope
**Type:** SECONDARY
**Unit of Measure:** degrees
##### Group
**Description:** 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.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** 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.
**ID:** OG001
**Title:** Traditional Metal Instruments
### Participant Flow Module
#### Group
**Description:** 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.
**ID:** FG000
**Title:** Customized Patient Instruments
#### Group
**Description:** 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.
**ID:** FG001
**Title:** Traditional Metal Instruments
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 11
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 11
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True