ScoliosisPEDSCOLINCT02084264
Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis
An observational study of Scoliosis, run by Mazor Robotics at 4 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Scoliosis
- How many people
- 272 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2014to 8 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric/adolescent patients (age 21 years and younger) undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater
Who may be able to join
- Pediatric/adolescent patients (age 10 to 21 years), undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater
- Patient capable of complying with study requirements
- Signed informed consent by patient
Who cannot join
- Scheuermann's disease
- Infection or malignancy
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Primary muscle diseases, such as muscular dystrophy
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
- Spinal cord abnormalities with any neurologic symptoms or signs
Show all 13Show fewer
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
- Patients requiring anterior release or instrumentation
- 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.
- Pregnancy
- Patient cannot follow study protocol, for any reason
- Patient cannot or will not sign informed consent
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Healtchare of Atlanta at Scottish Rite
Atlanta, Georgia, 30342
Geisinger Orthopaedic Institute
Danville, Pennsylvania, 17822
Florida Hospital for Children
Orlando, Florida, 32801
Rady Children's Hospital- San Diego
San Diego, California, 92123
About this study
Official title: Multicenter, Prospective, Partially Randomized, Controlled Trial of Robotic-guided vs. Freehand Corrective Surgery for Pediatric Scoliosis
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
- Conditions
- Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, Pediatric Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Robotic-guided, open approach | Robotic-guided, open approach | |
| Arm 2: control arm- non-robotic, open approach | control arm- non-robotic, open approach° |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision surgeries
All cause revisions, including medical and surgical complications.
Measured: 1 year post-surgery
Secondary outcomes (10)
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
Measured: Day of surgery
Neuromonitoring events
Measured: Day of surgery
Hypoplastic pedicles
<4 mm in diameter
Measured: Day of surgery
Improvement of radiographic and health-related quality of life metrics
post-operative radiographs and SRS22 questionnaire
Measured: up to 10 years post-operative
Length of convalescence
Length of hospital stay, destination at discharge, time to return to normal activities
Measured: within 2 years of surgery
Clinical Outcomes as measured on plain radiographs
Curvature correction and shoulder balance
Measured: 2 years
Radiation Exposure
Reading of exposure in seconds (and KvP, if available) from C-arm or other imaging system used in the operating room.
Measured: Day of surgery
Ratio of executed vs. planned screws
Number of screws planned to be robotically inserted and manually inserted instead, and cause.
Measured: Day of surgery
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.
Measured: Within 1 year of surgery, if indicated by surgeon and clinically necessary
Surgical complications
Implant-related durotomy, infection requiring surgery, excessive blood loss, air emboli, new neural deficits, implant failure
Measured: Within first year from day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startOct 2014
- Primary completion8 Jul 2019
- Study completion8 Jul 2019
Why it stopped: Administrative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazor Robotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doron Dinstein, MD, Study director, Mazor Robotics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084264
- Sponsor's protocol ID
- CLN108
- Acronym
- PEDSCOLI
- Status last verified
- Jul 2019
- First submitted
- 9 Mar 2014
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer 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.
PubMed 21079498
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Partially Randomized, Controlled Trial of Robotic-guided vs. Freehand Corrective Surgery for Pediatric Scoliosis
- ClinicalTrials.gov ID
- NCT02084264
- Acronym / sponsor ID
- PEDSCOLI / CLN108
- Conditions
- Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, Pediatric Scoliosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Administrative
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Mazor RoboticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Robotic-guided, open approach | – | –Robotic-guided, open approach |
| Arm 2: control arm- non-robotic, open approach | – | –control arm- non-robotic, open approach° |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric/adolescent patients (age 21 years and younger) undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater
Key inclusion criteria (3 listed)
- Pediatric/adolescent patients (age 10 to 21 years), undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater
- Patient capable of complying with study requirements
- Signed informed consent by patient
Key exclusion criteria (13 listed)
- Scheuermann's disease
- Infection or malignancy
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Primary muscle diseases, such as muscular dystrophy
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Revision surgeries
Time frame: 1 year post-surgery
All cause revisions, including medical and surgical complications.
10 secondary outcomes
Clinical performance of instrumentation technique
Time frame: Day of surgery
Neuromonitoring events
Time frame: Day of surgery
Hypoplastic pedicles
Time frame: Day of surgery
Improvement of radiographic and health-related quality of life metrics
Time frame: up to 10 years post-operative
Length of convalescence
Time frame: within 2 years of surgery
Clinical Outcomes as measured on plain radiographs
Time frame: 2 years
Radiation Exposure
Time frame: Day of surgery
Ratio of executed vs. planned screws
Time frame: Day of surgery
Pedicle screw instrumentation accuracy
Time frame: Within 1 year of surgery, if indicated by surgeon and clinically necessary
Surgical complications
Time frame: Within first year from day of surgery
Results and safety
The study was stopped early (reason given: Administrative). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Background: PubMed 21079498Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doron Dinstein, MD study director
Mazor Robotics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by Mazor Robotics at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Administrative). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision surgeries (time frame: 1 year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02084264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.