Trial Outcomes & Findings for Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial (NCT NCT02773537)

NCT ID: NCT02773537

Last Updated: 2019-03-27

Results Overview

The primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 48 hours after procedure
• Results posted on: 2019-03-27

Participant Flow

Recruitment occurred between October 2015 and August 2016. Patients were approached for participation in the study during their pre-op medical clearance clinic appointment.

A total of 107 patients undergoing primary TKA met initial eligibility criteria and were offered participation in the trial. 75 total subjects were randomized and considered enrolled to one of three arms of the study. 32 patients were excluded for various reasons prior to randomization.

Participant milestones

Measure	Femoral Nerve Catheter and Sciatic Nerve Block Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Overall Study STARTED	25	25	25
Overall Study COMPLETED	25	24	21
Overall Study NOT COMPLETED	0	1	4

Reasons for withdrawal

Measure	Femoral Nerve Catheter and Sciatic Nerve Block Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Overall Study Lost to Follow-up	0	1	4

Baseline Characteristics

Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial

Baseline characteristics by cohort

Measure	Femoral Nerve Catheter and Sciatic Nerve Block n=25 Participants Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block n=25 Participants Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only n=25 Participants Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb	Total n=75 Participants Total of all reporting groups
Age, Continuous	60.1 years STANDARD_DEVIATION 6.1 • n=5 Participants	65.7 years STANDARD_DEVIATION 9.5 • n=7 Participants	65.6 years STANDARD_DEVIATION 6.8 • n=5 Participants	63.8 years STANDARD_DEVIATION 7.5 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants	52 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	25 participants n=5 Participants	75 participants n=4 Participants
Baseline VAS Pain Score	5 Score on a scale n=5 Participants	6 Score on a scale n=7 Participants	6 Score on a scale n=5 Participants	6 Score on a scale n=4 Participants

PRIMARY outcome

Timeframe: 48 hours after procedure

The primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome.

Outcome measures

Measure	Femoral Nerve Catheter and Sciatic Nerve Block n=25 Participants Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block n=25 Participants Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only n=25 Participants Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Pain Measurement Via VAS (Visual Analog Scale)	4.11 score on a scale Standard Deviation .43	4.68 score on a scale Standard Deviation .44	4.36 score on a scale Standard Deviation .42

SECONDARY outcome

Timeframe: 48 hours after procedure

Narcotic dosages will be measured and reported as oral morphine milligram equivalents.

Outcome measures

Measure	Femoral Nerve Catheter and Sciatic Nerve Block n=25 Participants Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block n=25 Participants Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only n=25 Participants Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Narcotic Requirements	90 milligrams of morphine equivalents Interval 70.0 to 125.0	107.5 milligrams of morphine equivalents Interval 84.5 to 142.5	107 milligrams of morphine equivalents Interval 77.5 to 162.5

SECONDARY outcome

Timeframe: 1-2 days after procedure

Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. They will document the patient's ability to perform independent terminal knee extension and grade knee buckling with ambulation on a scale of 0-2 during each encounter. A grade of 0 indicates no knee buckling, 1 indicates slight buckling, and a grade of 2 represents knee buckling significant enough in the opinion of the physical therapist to require a knee immobilizer while ambulating. I higher score corresponds to a worse outcome. The numbers below in the outcome measure table are the number of patients who achieved terminal knee extension for had ANY knee buckling respectively.

Outcome measures

Measure	Femoral Nerve Catheter and Sciatic Nerve Block n=25 Participants Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block n=25 Participants Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only n=25 Participants Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Functional Outcome Measures- Exstension/Knee Buckling Terminal Knee Extension (Yes) (Post Op. Day 2)	13 number of participants	15 number of participants	22 number of participants
Functional Outcome Measures- Exstension/Knee Buckling Any Knee Buckling (Yes) (Post Op. Day 1)	20 number of participants	7 number of participants	8 number of participants
Functional Outcome Measures- Exstension/Knee Buckling Any Knee Buckling (Yes) (PPost Op. Day 2)	8 number of participants	4 number of participants	1 number of participants
Functional Outcome Measures- Exstension/Knee Buckling Terminal Knee Extension (YES)(Post Op Day 1)	10 number of participants	16 number of participants	20 number of participants

SECONDARY outcome

Timeframe: Morning of post-op day 1 - 2 days after procedure

Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #1, the therapist will calculate the Activity Measure for Post-Acute Care (AM-PAC) score. The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities,and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.

Outcome measures

Measure	Femoral Nerve Catheter and Sciatic Nerve Block n=25 Participants Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block n=25 Participants Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only n=25 Participants Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)	15.0 score on a scale Standard Deviation 2.0	16.5 score on a scale Standard Deviation 4.0	16.0 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Morning of post-op day 1 - 2 days after procedure

Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document distance walked by the patient.

Outcome measures

Measure	Femoral Nerve Catheter and Sciatic Nerve Block n=25 Participants Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block n=25 Participants Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only n=25 Participants Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked	80 Feet Standard Deviation 102	155 Feet Standard Deviation 150	160 Feet Standard Deviation 105

SECONDARY outcome

Timeframe: Morning of post-op day 1 - 2 days after procedure

Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document a timed up-and-go test (TUG).

Outcome measures

Measure	Femoral Nerve Catheter and Sciatic Nerve Block n=25 Participants Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block n=25 Participants Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only n=25 Participants Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds	66.1 seconds Standard Deviation 32.0	61.9 seconds Standard Deviation 29.6	65.3 seconds Standard Deviation 39.3

SECONDARY outcome

Timeframe: 6 Weeks after procedure

Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.

Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20 and the max is 100.

Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).

Outcome measures

Measure	Femoral Nerve Catheter and Sciatic Nerve Block n=25 Participants Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block n=25 Participants Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only n=25 Participants Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Patient Reported Pain and Function Outcomes KOOS Pain	63.3 score on a scale Standard Deviation 19.0	57.8 score on a scale Standard Deviation 17.0	62.6 score on a scale Standard Deviation 15.8
Patient Reported Pain and Function Outcomes KOOS Symptom	61.7 score on a scale Standard Deviation 21.8	62.6 score on a scale Standard Deviation 16.9	58.7 score on a scale Standard Deviation 13.2
Patient Reported Pain and Function Outcomes PROMIS	37.4 score on a scale Standard Deviation 4.76	41.5 score on a scale Standard Deviation 6.35	39.2 score on a scale Standard Deviation 6.42

SECONDARY outcome

Timeframe: 3 Months after Procedure

Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.

Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20, the maximum is 100.

Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).

Outcome measures

Measure	Femoral Nerve Catheter and Sciatic Nerve Block n=25 Participants Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block n=25 Participants Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only n=25 Participants Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Patient Reported Pain and Function Outcomes KOOS Pain	66.8 score on a scale Standard Deviation 19.8	72.6 score on a scale Standard Deviation 18.4	70.5 score on a scale Standard Deviation 17.3
Patient Reported Pain and Function Outcomes KOOS Symptom	64.3 score on a scale Standard Deviation 19.0	71.7 score on a scale Standard Deviation 12.9	67.4 score on a scale Standard Deviation 15.8
Patient Reported Pain and Function Outcomes PROMIS	41.1 score on a scale Standard Deviation 6.92	45.4 score on a scale Standard Deviation 7.17	44.4 score on a scale Standard Deviation 6.04

Adverse Events

Femoral Nerve Catheter and Sciatic Nerve Block

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adductor Canal Catheter and Selective Tibial Block

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adductor Canal Catheter Only

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Femoral Nerve Catheter and Sciatic Nerve Block n=25 participants at risk Femoral nerve catheter and sciatic nerve block Femoral nerve catheter and sciatic nerve block: This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter and Selective Tibial Block n=25 participants at risk Adductor canal catheter and selective tibial block Adductor canal catheter and selective tibial block: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.	Adductor Canal Catheter Only n=25 participants at risk Adductor canal catheter only Adductor canal catheter only: This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
Musculoskeletal and connective tissue disorders Arthrofibrosis requiring manipulation under anesthesia	4.0% 1/25 • Number of events 1 • 3 months post operatively	0.00% 0/25 • 3 months post operatively	0.00% 0/25 • 3 months post operatively
Musculoskeletal and connective tissue disorders Flexion Contracture	4.0% 1/25 • Number of events 1 • 3 months post operatively	0.00% 0/25 • 3 months post operatively	0.00% 0/25 • 3 months post operatively
Musculoskeletal and connective tissue disorders Transient thigh muscle spasms, anterior and posterior	0.00% 0/25 • 3 months post operatively	4.0% 1/25 • Number of events 1 • 3 months post operatively	0.00% 0/25 • 3 months post operatively
Musculoskeletal and connective tissue disorders Prolonged wound drainage	0.00% 0/25 • 3 months post operatively	8.0% 2/25 • Number of events 2 • 3 months post operatively	0.00% 0/25 • 3 months post operatively
Musculoskeletal and connective tissue disorders Transient posterior thigh burning	0.00% 0/25 • 3 months post operatively	4.0% 1/25 • Number of events 1 • 3 months post operatively	0.00% 0/25 • 3 months post operatively
Musculoskeletal and connective tissue disorders Persistent decreased sensation, lateral heel Hemarthrosis	0.00% 0/25 • 3 months post operatively	4.0% 1/25 • Number of events 1 • 3 months post operatively	0.00% 0/25 • 3 months post operatively
Musculoskeletal and connective tissue disorders Patellar Tendon rupture after Fall	0.00% 0/25 • 3 months post operatively	0.00% 0/25 • 3 months post operatively	4.0% 1/25 • Number of events 1 • 3 months post operatively
Musculoskeletal and connective tissue disorders Pulmonary embolus	0.00% 0/25 • 3 months post operatively	0.00% 0/25 • 3 months post operatively	4.0% 1/25 • Number of events 1 • 3 months post operatively

Additional Information

Dr. Eric Bolin

Medical University of South Carolina

Phone: 843-792-2322

Email: bolin@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place