Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis

Scoliosis Clinical Trial

— PEDSCOLI  

Official title:

Multicenter, Prospective, Partially Randomized, Controlled Trial of Robotic-guided vs. Freehand Corrective Surgery for Pediatric Scoliosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02084264
• Other study ID #: CLN108
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Scoliosis

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