Scoliosis Clinical Trial
Official title:
ADDRESS - Multicenter, Partially-randomized Controlled Trial of Adult Deformity Robotic vs. Freehand Surgery to Correct Adult Spine Deformity
NCT number | NCT02058238 |
Other study ID # | CLN105 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | October 3, 2014 |
Est. completion date | March 1, 2015 |
Verified date | September 2020 |
Source | Mazor Robotics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
Mazor Robotics |
United States,
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
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 |
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