Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery
Phase: NA
Conditions: Surgical Blood Loss, Spinal Surgery
Sponsor: University of Miami

IRB Study Number: 20161061 
 
Intraoperative Efficacy of Suction 
Enabled Retraction Device in 
Lumbar Spine Surgery 
 
National Clinical Trial Number: NCT03160170 
 
Study Number: 20161061 
 
Date: March 15, 2017 
 

IRB Study Number: 20161061 
 
Principal Investigator: Ian Cõté, MD  
 
 
1) Protocol Title 
Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine 
Surgery 
 
2) Objectives* 
This is a prospective randomized controlled trial of a new surgical instrument to 
assess: 
• Effects on operative time and efficiency of exposure in open lumbar spine 
cases. 
• Effect on total blood loss during the exposure part of the operation. 
• Rate of clogging of suction device. 
 
3) Background* 
During spinal surgery, exposure of bony anatomy requires the use of retraction, 
suction, and electrocautery at the same time. As three instruments are generally 
used – a Cobb elevator, electrocautery, and suction – an assistant is generally 
required or the primary surgeon has to switch between the instruments. The 
resultant juggling of instruments and/or reliance on an assistant can influence 
operating time and efficiency. 
 
The new device, Suction-Integrated Surgical Tissue Elevator & Retractor 
[SISTER], is shaped like a Cobb elevator but also has a hollow core allowing 
suction tubing to be connected. Thus, a single hand can be used to retract and 
suction at the same time while the other hand separates soft tissue from the bones 
with electrocautery. This set up which is proposed to be more efficient will be 
evaluated in this study. 
 
The device is made of high density plastic material and is disposable. The device 
meets FDA’s Medical Device Exemption 510(k) Requirements (Please see 
uploaded letter from Ludwig Medical Corporation). 
 
4) Inclusion and Exclusion Criteria* 
 
Inclusion 
English-speaking patients undergoing Lumbar One to Sacral One open 
instrumentation performed by attending physicians in the Departments of 
Neurological Surgery and Orthopedic surgery will be included. 
 
 
Exclusion 
• Age less than 22 years old 
• Patients whose procedure will not involve instrumentation 

IRB Study Number: 20161061 
 
• Patients with prior Lumbar spine surgery involving more than one level 
• BMI less than 20 or greater than 35 
• Patients with known bleeding conditions (ex: Factor V Leiden, Von 
Willebrand’s,) 
• Patients that routinely take anticoagulation medicine (ex. Aspirin 325mg/day, 
Plavix) 
• Operative cases where a single surgeon performs both sides of exposure. 
• Pregnant women 
• Prisoners 
• Adults unable to consent 
 
 
5) Procedures Involved* 
Patients will be selected prospectively and randomly assigned to either the control 
group (standard exposure technique) or the suction-integrated Cobb group. 
Randomization will be performed with a coin toss: “best two out of three” style. For 
example, if “heads” represents the “control” group, 2 out of 3 tosses resulting in 
“heads” will assign a given patient to the control group, and if “tails” represents the 
“suction-integrated Cobb group” 2 out of 3 tosses resulting in “tails” will assign the 
patient to the suction-integrated Cobb group. Randomization will stop once 20 
subjects are enrolled in the suction-integrated Cobb group. If at that time, the 
control group has less than 20 subjects, all subsequent subjects will be assigned to 
the control group. 
 
During the consent process, patients will be informed that a new instrument may be 
used during their surgery. The risks of using the device will be explained to the 
patient, which will include the surgeon’s discomfort when using the new 
instrument, or failure of the device, which may lead to a delay during the exposure 
phase of surgery, which could ultimately result in a longer surgery. Surgeons will 
be given time to become familiar with the instrument. Operative data will be 
collected.  
 
In the control group, the surgeons will utilize standard exposure technique and 
instruments. In the suction-integrated Cobb group, surgeons will be provided with 
the device. Standard equipment will also be readily available in case the surgeon 
decides for any reason not to use the device. The device will be provided by 
Ludwig Medical Corporation, the manufacturers of the device. 
 
The following data will be recorded: age, gender, BMI, spinal levels involved, 
overall operative time, exposure time measured from skin incision until adequate 
exposure is achieved by the surgeon, blood loss during the exposure, and number of 
times the suction had to be unclogged. 
 
No postoperative follow up is required. 
 
A total of 40 patients will be randomized, with twenty assigned to each group. 

IRB Study Number: 20161061 
 
 
6) Data Management* 
         All study staff will be CITI certified and will be trained in handling confidential 
medical information. Data will be stored on a password-protected computer in a 
secured location. Data will be coded and each subject will be assigned a unique 
study number. The linking code will be stored separately and will only be 
accessible to the study team. Only research members approved by the IRB will have 
access to the data.  
 
 
Power analyses has determined that 36 subjects (2 groups of 18) would be sufficient 
to demonstrate a significant effect. The parameters and assumptions of this analysis 
are as follows: an average exposure time with typical instruments of 30 (±15) 
minutes, a 45% reduction in exposure time previously demonstrated in a previous 
small study with the new device, a 1:1 enrollment ratio for sub-groups, an alpha 
value of 0.05 for significance, and power value of 80%. Our proposed study size of 
40 subjects will therefore confer statistical power.  
 
7) 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
The PI will be responsible for data and safety monitoring. Any suspected or 
observed breach in data security will be reported to the PI and IRB.  
 
The data collected and planned analyses are described above. Data will be collected 
before, during, and after each patient’s surgery, and will be reviewed by study staff. 
The trial will be suspended if a breach of security is observed, or harm is 
demonstrated to subjects. 
 
8) Withdrawal of Subjects 
Subjects will be withdrawn from the study if their planned surgical procedure is 
cancelled or changed in such a way as to no longer meet inclusion criteria for the 
study. If a subject withdraws from the study, or is withdrawn from the study, the 
study staff will stop collecting new information about the subject. However, the 
study team will use the information they have already collected.  
 
9) Risks to Subjects* 
The risks associated with this study are largely those of the surgery itself. 
Additionally, the surgeon may not be comfortable using the new instrument, or the 
device may fail, which may lead to a delay during the exposure phase of the 
surgery. Also, as part of this research, there is a possibility of a breach of 
confidentiality (your private information) of your medical data. We will take 
adequate steps to protect your confidentiality. In addition, there may be uncommon 
or previously unknown risks that might occur. 
 
10) 
Potential Benefits to Subjects* 
Patients may benefit from a potential decrease in operative time, anesthesia 
time, and reduced blood loss. 

IRB Study Number: 20161061 
 
11) 
Vulnerable Populations* 
Not applicable. 
12) 
Setting 
The research will be conducted at Jackson Memorial Hospital. 
13) 
Resources Available 
All research personnel are CITI Certified. 
 
Ludwig Medical Corporation will provide 40 devices free of charge for the study. 
 
14) 
Recruitment Methods 
Surgeons in the Departments of Orthopedics and Neurological Surgery 
will refer eligible patients to the study. Subjects for the proposed study 
will be those who have already decided to undergo lumbar spine surgery.  
Subjects will be selected prospectively based on the proposed operative 
plan and randomized to one of the two groups (control vs suction-
integrated Cobb groups).  
15) 
Local Number of Subjects 
Forty patients will be included. 
 
16) 
Confidentiality 
• Data will be stored on a password-protected computer in Dr. Cõté’s office. 
• Data will be coded and each subject will be assigned a unique study number. 
The linking code will be stored separately and will only be accessible to the 
study team. 
• Only those research staff members approved by the IRB will have access to 
all research related data.  
 
17) 
Provisions to Protect the Privacy Interests of Subjects 
All data necessary and sufficient for the conduct of the study will be collected and 
stored as described in the “Confidentiality” section. This information will be both 
identifiable and non-identifiable data. General information will be collected about 
the patients from the medical records. 
 
18) 
Compensation for Research-Related Injury 
 If injury should occur, treatment will be available. If subjects have insurance, their 
insurance company may or may not pay for these costs. If subjects do not have 
insurance, or if their insurance company refuses to pay, subjects will be expected to 
pay. Funds to compensate for pain, expenses, lost wages and other damages caused 
by injury are not available. 
 
19) 
Economic Burden to Subjects 
This study involves no financial cost to subjects. 

IRB Study Number: 20161061 
 
 
20) 
Consent Process 
Participants in this study will have already consented to surgery prior to being 
approached regarding participation in the study. Any concerns with the study or 
information collected will be discussed with the subjects. 
 
Prior to surgery, the patient will be approached by the Investigator or one of the 
Sub-Investigators who will present a sample device and describe its function as well 
as the goal of the study. The patient will be given an opportunity to ask any 
questions about the device and the study. If the patient agrees to participate, he/she 
will be asked to sign the consent form. 
 
Spanish-speaking participants will not be included in this study, as at this time there 
are no funds to translate the consent documents. 
 
21) 
Process to Document Consent in Writing 
Documentation of the informed consent process will include the following 
information:   
 
• Consent will be obtained prior to any study related procedures being 
performed.  The ICF will be fully explained and any questions will be 
answered to the satisfaction of the subject.   
• Subjects’ will receive a signed copy of the ICF and HIPAA authorization 
forms.  The ICF process will be performed in a language that the subject 
comprehended fluently.  Specific questions asked by the subject will be 
documented.   
• A copy of all executed ICFs and HIPAA forms will be provided to 
supporting programs/units/entities (e.g. JHS Medical Records and Clinical 
Trial Office). 
 
22) 
Drugs or Devices 
A company representative will bring the device to the hospital on the day of surgery 
for each case enrolled in the study. Institutional and legal protocols will be followed 
in bringing the device to the hospital. Sterile procedures will be followed in opening 
and employing the device.