ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity

Scoliosis Clinical Trial

Official title:

ADDRESS - Multicenter, Partially-randomized Controlled Trial of Adult Deformity Robotic vs. Freehand Surgery to Correct Adult Spine Deformity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02058238
• Other study ID #: CLN105
• Status: Withdrawn
• Start date: October 3, 2014
• Est. completion date: March 1, 2015

Study information

• Verified date: September 2020
• Source: Mazor Robotics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To quantify potential short- and long-term benefits of robotically-guided minimally invasive (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a matching cohort of control patients, performed using a freehand technique, both in MIS and open approaches.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2015
• Est. primary completion date: March 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.

2. Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis.

3. Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).

4. Patient capable of complying with study requirements

5. Signed informed consent by patient

Exclusion Criteria:

1. Infection or malignancy

2. Primary abnormalities of bones (e.g. osteogenesis imperfecta)

3. Primary muscle diseases, such as muscular dystrophy

4. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)

5. Spinal cord abnormalities with any neurologic symptoms or signs

6. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia

7. Paraplegia

8. Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery

9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.

10. Pregnancy

11. Patient cannot follow study protocol, for any reason

12. Patient cannot or will not sign informed consent

Related Conditions & MeSH terms

• Congenital Abnormalities
• Kyphoscoliosis
• Kyphosis
• Scoliosis
• Spinal Deformity
• Spondylosis

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Mazor Robotics

Country where clinical trial is conducted

United States, 

References & Publications (2)

Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stüer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab. Erratum in: Spine (Phila Pa 1976). 2011 Jan 1;36(1):91. Gordon, Donald G [corrected to Donald, Gordon D]. — View Citation

Hu X, Ohnmeiss DD, Lieberman IH. Use of an ultrasonic osteotome device in spine surgery: experience from the first 128 patients. Eur Spine J. 2013 Dec;22(12):2845-9. doi: 10.1007/s00586-013-2780-y. Epub 2013 Apr 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of surgical complications	New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss	1 year
Primary	Intraoperative radiation exposure	as measured by the C-arm, normalized per screw	Day of operation
Primary	Revision surgeries	All cause revisions, including medical and surgical complications.	2 years
Secondary	Deformity correction as measured on plain radiographs	Parameters of sagittal and coronal balance	Within 2 years from surgery
Secondary	Clinical outcome measures assessed using health-related quality of life questionnaires	Visual Analog Scale (VAS) back and leg, Oswestry Disability Index (ODI), SRS22 questionnaire, European Quality - 5 dimensions (EQ-5D-5L)	up to 10 years post-operative
Secondary	Pedicle screw instrumentation accuracy	Accuracy will be quantified in millimeters and scored using the Gertzbein Robbins classification, based on post-operative CTs that are clinically necessary for the management of the patient.	Within 1 year of surgery
Secondary	Length of convalescence	Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work	Within 2 years of surgery
Secondary	Ratio of executed vs. planned screws	Number of screws planned to be robotically inserted but manually inserted instead, and cause.	Day of surgery
Secondary	Times of intra-operative stages	Instrumentation time per screw, total surgery time	Day of surgery
Secondary	Implant Failure	The implant failure rate as measured within one year post-surgery	Within 1 year post-surgery
Secondary	Number of Abandoned Screws	Number of screws intended to be instrumented with the robot and abandoned for cause.	Day of surgery
Secondary	Number of screws instrumented freehand	Number of screws planned to be instrumented robotically and instrumented freehand instead.	Day of surgery
Secondary	Clinical performance of instrumentation technique	Implant instrumentation time, length of surgery	Day of surgery
Secondary	Fusion rate/pseudoarthrosis	Fusion/pseudoarthrosis as measured within one year of surgery	Within one year post-surgery
Secondary	Neuromonitoring events	The number of clinically significant neuromonitoring events that may or may not lead to removal or reinstrumentation of the pedicle screw.	Day of surgery