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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02084264
Other study ID # CLN108
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 2014
Est. completion date July 8, 2019

Study information

Verified date July 2019
Source Mazor Robotics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients


Recruitment information / eligibility

Status Terminated
Enrollment 272
Est. completion date July 8, 2019
Est. primary completion date July 8, 2019
Accepts healthy volunteers No
Gender All
Age group 10 Years to 21 Years
Eligibility Inclusion Criteria:

1. Pediatric/adolescent patients (age 10 to 21 years), undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater

2. Patient capable of complying with study requirements

3. Signed informed consent by patient

Exclusion Criteria:

1. Scheuermann's disease

2. Infection or malignancy

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

4. Primary muscle diseases, such as muscular dystrophy

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

6. Spinal cord abnormalities with any neurologic symptoms or signs

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

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

9. Patients requiring anterior release or instrumentation

10. 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.

11. Pregnancy

12. Patient cannot follow study protocol, for any reason

13. Patient cannot or will not sign informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Children's Healtchare of Atlanta at Scottish Rite Atlanta Georgia
United States Geisinger Orthopaedic Institute Danville Pennsylvania
United States Florida Hospital for Children Orlando Florida
United States Rady Children's Hospital- San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Mazor Robotics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Revision surgeries All cause revisions, including medical and surgical complications. 1 year post-surgery
Secondary Clinical performance of instrumentation technique instrumentation time per screw, total surgery time, excluding: exposure and closure time, Surgeon-specific surgical techniques that impact surgery time Day of surgery
Secondary Neuromonitoring events Day of surgery
Secondary Hypoplastic pedicles <4 mm in diameter Day of surgery
Secondary Improvement of radiographic and health-related quality of life metrics post-operative radiographs and SRS22 questionnaire up to 10 years post-operative
Secondary Length of convalescence Length of hospital stay, destination at discharge, time to return to normal activities within 2 years of surgery
Secondary Clinical Outcomes as measured on plain radiographs Curvature correction and shoulder balance 2 years
Secondary Radiation Exposure Reading of exposure in seconds (and KvP, if available) from C-arm or other imaging system used in the operating room. Day of surgery
Secondary Ratio of executed vs. planned screws Number of screws planned to be robotically inserted and manually inserted instead, and cause. Day of surgery
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, if indicated by surgeon and clinically necessary
Secondary Surgical complications Implant-related durotomy, infection requiring surgery, excessive blood loss, air emboli, new neural deficits, implant failure Within first year from day of surgery
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