Visionaire™ Versus Standard Instrumentation Safety and Ef... | NCT01084772

Label	Type	Description	Intervention Names
VISIONAIRE Instrumentation	Other	TKA with VISIONAIRE instrumentation	Other: VISIONAIRE Total Knee Arthroplasty
Standard Instrumentation	Other	TKA with standard instrumentation	Other: Standard Total Knee Arthroplasty

Name	Type	Description	Arm Group Labels	Other Names
VISIONAIRE Total Knee Arthroplasty	Other	TKA will be performed with VISIONAIRE instrumentation, depending on randomization assignment.	VISIONAIRE Instrumentation

Measure	Description	Time Frame
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score	The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects.	2 years postoperatively
Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire	The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS clinical evaluation included a questionnaire completed by the investigators to assess for pain, stability, flexion contracture, extension lag, and alignment and evaluated based on number of subjects experiencing any of these issues at the 2-year postoperative visit.	2 years postoperatively

Measure	Description	Time Frame
Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray	Long radiographic anterior-posterior (AP) (full-leg standing x-rays) of the entire limb are superior for measuring alignment of the knee as the limb mechanical axes may be more precisely computed. For full-leg x-rays, 2 lines were drawn on the radiograph. First, a line was drawn from the center of the femoral head to the center of the femoral intercondylar notch and the line was extended through to the ankle. Second, a line was drawn from the center of the tibial spine to the center of the ankle talus. The angle between the first and second line was measured to determine mechanical alignment and assessed as either neutral (0 degrees) or a number of degrees of varus or valgus.

Name	Affiliation	Role
Beate Hanson, MD, PhD	Smith & Nephew, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Orthopaedic Surgery Specialist, Ltd.		Park Ridge	Illinois	60068	United States
Southern Illinois University School of Medicine

ID	Title	Description
FG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.

ID	Title	Description
BG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
BG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00068 BG00165 BG002133

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score

The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects.

The Knee Society Clinical Score was not completed for all enrolled subjects. Data was only available for 83 subjects.

Posted

Mean

Standard Deviation

score on a scale

2 years postoperatively

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Units	Counts
Participants	OG00042 OG00141

Title

Denominators

Categories

Title	Measurements
	OG00091.4± 13.7 OG00194.3± 8.9

Primary

Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire

The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS clinical evaluation included a questionnaire completed by the investigators to assess for pain, stability, flexion contracture, extension lag, and alignment and evaluated based on number of subjects experiencing any of these issues at the 2-year postoperative visit.

Posted

Count of Participants

Participants

2 years postoperatively

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Units	Counts
Participants

Secondary

Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray

Long radiographic anterior-posterior (AP) (full-leg standing x-rays) of the entire limb are superior for measuring alignment of the knee as the limb mechanical axes may be more precisely computed. For full-leg x-rays, 2 lines were drawn on the radiograph. First, a line was drawn from the center of the femoral head to the center of the femoral intercondylar notch and the line was extended through to the ankle. Second, a line was drawn from the center of the tibial spine to the center of the ankle talus. The angle between the first and second line was measured to determine mechanical alignment and assessed as either neutral (0 degrees) or a number of degrees of varus or valgus.

Evaluation of Mechanical Alignment 3 Months Postoperatively was not completed for all enrolled subjects. Only data for 88 participants was available.

Posted

Count of Participants

Participants

3 months postoperative

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation

Secondary

Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively

Evaluation of KOOS questionnaire total scores including categories for symptoms, pain, function of daily living, function of sports and recreational activities, and quality of life. KOOS total scores ranged from 0 to 100, with 0 indicating worst (no function) and 100 indicating no symptoms at all.

Not all enrolled subjects completed the KOOS questionnaire at each time point.

Posted

Mean

Standard Deviation

score on a scale

Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Units	Counts

Secondary

Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively

X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (> 2 mm). Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.

Not all subjects completed the serial radiographic evaluations at the specified time points.

Posted

Number

participants

1 year postoperatively

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Secondary

Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively

X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed.

Not all subjects completed the serial radiographic evaluations at the specified time points.

Posted

Number

participants

1 year postoperatively

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Units	Counts
Participants

Secondary

Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively

X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (> 2 mm), lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.

Not all subjects completed the serial radiographic evaluations at the specified time points.

Posted

Number

participants

2 years postoperatively

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Secondary

Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively

Not all subjects completed the serial radiographic evaluations at the specified time points.

Posted

Number

participants

2 years postoperatively

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Units	Counts
Participants

Secondary

Evaluation of Health Economic Criteria - Surgical Time Details

Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.

Not all analysis values were available for all enrolled subjects.

Posted

Mean

Standard Deviation

minutes

During and immediately following surgery

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Units	Counts
Participants

Secondary

Evaluation of Health Economic Criteria - Blood Loss

Not all analysis values were available for all enrolled subjects.

Posted

Mean

Standard Deviation

During and immediately following surgery

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Units	Counts
Participants

Secondary

Evaluation of Health Economic Criteria - Incision Length

Not all analysis values were available for all enrolled subjects.

Posted

Mean

Standard Deviation

During and immediately following surgery

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Units	Counts
Participants

Secondary

Evaluation of Health Economic Criteria - Instrument Tray Use

Not all analysis values were available for all enrolled subjects.

Posted

Mean

Standard Deviation

number of trays

During and immediately following surgery

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Units	Counts
Participants

Secondary

Evaluation of Health Economic Surgical Criteria

Analysis of health data captured during and immediately following surgery: surgical approach, cut order, final status of posterior cruciate ligament (PCL), and need for perioperative prophylaxis antibiotics.

Posted

Number

participants

During and immediately following surgery

ID	Title	Description
OG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.
OG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Chest pain	Cardiac disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events1 affected66 at risk
Confusion	General disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Anemia	Blood and lymphatic system disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Painful, hot, stiff knee post-op	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Stiff knee requiring manipulation under anesthesia	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events2 affected66 at risk
Contralateral TKR	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected66 at risk
Weight gain	Metabolism and nutrition disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Diabetes	Endocrine disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Knee pes tendonitis	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Vascular calcification, right leg popliteal artery	Blood and lymphatic system disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Decreased ROM left knee secondary to post-op chest infection, unable to do PT	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Suspected chest infection 1 week post-op	Infections and infestations	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Superficial wound infection	Infections and infestations	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Low back pain	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Post-op wound inflammation, question of stitch reaction	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Cancer of prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Fall on operated knee resulting in pain	Injury, poisoning and procedural complications	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Fall - painful knee and wrist	Injury, poisoning and procedural complications	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Right hip fracture	Injury, poisoning and procedural complications	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Planned left THA	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Left IT band tendonitis	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Left knee slight clicking sensation	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment	Determined to be not related, resolved.	EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Wound dehiscence/extruded stitches	Injury, poisoning and procedural complications	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Left knee arthroscopy	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Bilateral DVT	Blood and lymphatic system disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Pulmonary embolism	Blood and lymphatic system disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Patient fell on buttock, increased left knee discomfort	Injury, poisoning and procedural complications	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Right total knee arthroplasty	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0014 events4 affected66 at risk
Arterial blood clots due to mitral valve disease; had a TEE	Cardiac disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events1 affected66 at risk
Medial joint line tenderness with certain twisting maneuvers	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Cervical stenosis with cervical DJD	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Nausea postoperatively during hospitalization	Gastrointestinal disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Gastroenteritis	Gastrointestinal disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Left total knee arthroplasty	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0013 events3 affected66 at risk
Patient fell and had minor bruising to study knee	Injury, poisoning and procedural complications	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Mild lateral pain by insertion of ITB left study knee	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Bilateral thigh pain, left worse than right	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Bilateral trochanteric bursitis - hips	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Brain tumor	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Left total shoulder replacement	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Painful left knee	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Lumbar laminectomy, fusion of L3-5 and iliac crest bone graft	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Heart surgery, insertion of mechanical valve in aorta	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Surgery for bladder prolapse, mesh removal	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Ascending aortic dissection repair	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Chest pain, dx stenosis; catheterization and stent placement	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Hernia repair	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
L5-S1 lumbar epidural steroid injection	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0007 events1 affected68 at risk EG0010 events0 affected66 at risk
Back surgery for back pain	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Nephrolithiasis	Renal and urinary disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Removal of prosthesis, left unicompartmental knee arthroplasty revision	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Bright red blood from rectum and constipation while in hospital	Gastrointestinal disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Left knee instability	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Appendectomy	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Septic knee	Infections and infestations	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Anemia	Blood and lymphatic system disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Re-hospitalization for GI bleed and anemia	Gastrointestinal disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Wound dehiscence requiring sutures	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Arthroscopic shoulder debridement and biceps tenolysis	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Cervical fusion	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Pancreatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Whipple procedure	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Right carpal tunnel release	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Moderate effusion requiring aspiration	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0004 events3 affected68 at risk EG0010 events0 affected66 at risk
Moderate effusion	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Thrombophlebitis	Blood and lymphatic system disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Effusion	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Right distal radius fracture	Injury, poisoning and procedural complications	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Left distal radius fracture	Injury, poisoning and procedural complications	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Carpal tunnel pain with injection	Nervous system disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Right A1 pulley ganglion cyst aspiration	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Cervical disc decompression and fusion	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Left knee injection for osteoarthritis	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Low back/hip pain	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
DVT secondary to Factor V	Blood and lymphatic system disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Persistent knee pain after kneeling on study knee	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Mild effusion, aspiration performed	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Pain and discomfort in left knee due to osteoarthritis	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Right knee effusion	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Left knee effusion	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Peroneal and gastrocnemius vein clot at mid-calf	Blood and lymphatic system disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Repair of left rotator cuff tear	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Left knee arthroscopy	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Right knee aspiration due to effusion	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Right mid-foot pain requiring cortisone injection	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Constipation	Gastrointestinal disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected66 at risk
Knee swollen with no erythema	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Patient reported felt feverish post-op	General disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Poor ROM	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Pain in left knee	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Sed rate of 27; reference range 0-15	Blood and lymphatic system disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Skin and tissues around knee seem thick and woody	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Follow up for poor ROM	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Fell post-op x2 at home after standing and getting dizzy	Injury, poisoning and procedural complications	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events1 affected66 at risk
Patellar dislocation	Injury, poisoning and procedural complications	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Degenerative arthritis, right knee	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Atrial fibrillation after elective right TKA	Cardiac disorders	S & N proprietary	Systematic Assessment		EG0003 events1 affected68 at risk EG0010 events0 affected66 at risk
Hypotension	Cardiac disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Pericardial effusion	Cardiac disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Osteoarthritis right shoulder	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Ischial bursitis on left	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Syncope	General disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Hyponatremia	Metabolism and nutrition disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected66 at risk
Follow up for anemia	Blood and lymphatic system disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Vomiting	Gastrointestinal disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Swelling post-op right leg	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Left knee osteoarthritis	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Ileus	Gastrointestinal disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Poor ROM right knee	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Right knee pain	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events1 affected66 at risk
Erythema of wound	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Joint pain left knee	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Right TKA incision tenderness	Skin and subcutaneous tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Knee arthrofibrosis s/p TKA, treated with manipulation	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events1 affected66 at risk
Gastritis, with gallballder polys, had cholecystectomy	Gastrointestinal disorders	S & N proprietary	Systematic Assessment		EG0002 events1 affected68 at risk EG0010 events0 affected66 at risk
Abdominal pain	Gastrointestinal disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Colonoscopy	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Cough x2 days	Respiratory, thoracic and mediastinal disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Bilateral leg and foot pain; lumbar degenerative disc disease	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
TKA on contralateral leg	Surgical and medical procedures	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk
Acute blood loss anemia s/p surgery, transfusion not required	Blood and lymphatic system disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Blood in stool, suspected hemorrhoid	Gastrointestinal disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Left knee w/ mild pain and crepitance	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Degenerative disc disease w/ revision laminectomy	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected66 at risk
Back pain; dx degenerative disc disease and thoracic sprain	Musculoskeletal and connective tissue disorders	S & N proprietary	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected66 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	VISIONAIRE Instrumentation	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	1	68	0	68	43	68
EG001	Standard Instrumentation	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.	0	66	0	66	38	66