Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery

(MIS Trial)

Recruiting at 11 trial locations

Overseen By Ray Pinteric

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: International Spine Study Group Foundation

Disqualifiers: Acute trauma, Spine tumor, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 week

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients treated with minimally invasive approach, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.

Who Is on the Research Team?

Paul Park, MD

Principal Investigator

University of Michigan

Gregory Mundis, MD

Principal Investigator

Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CA

Praveen Mummaneni, MD

Principal Investigator

University of San Francisco

Juan Uribe, MD

Principal Investigator

Barrow Neurological Institute, Phoenix, AZ

Are You a Good Fit for This Trial?

Inclusion Criteria

a. Radiographic criteria incorporating percutaneous posterior spinal instrumentation: i. PI-LL ≥ 25 degrees ii. Thoracolumbar/lumbar scoliosis ≥ 20 degrees iii. SVA >10cm iv. PT > 30 b. Procedural criteria: i. Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 &/or pelvis/ilium is not) ii. Staged ≥ 3 levels fused with percutaneous pedicle screws iii. 3 column osteotomy with percutaneous fixation iv. ACR incorporating open or percutaneous fixation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo prehabilitation, pain management, and mental health care to improve treatment outcomes

4-6 weeks

Treatment

Participants receive minimally invasive surgery for complex adult spinal deformity

1 week

1 visit (in-person)

Postoperative Care

Participants are monitored for surgical and postoperative complications, and outcomes are evaluated

3 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Regular visits at 3 months, 1, 2, 5, and 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Index or Spine Revision Surgery for Complex Adult Spinal Deformity

How Is the Trial Designed?

Group I: Operative Experimental Treatment 1 Intervention

Multicenter, prospective, nonrandomized analysis of ASD patients w/diagnosis of congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity. Participants must be scheduled to have 3 or more levels of Percutaneous posterior spinal instrumentation or 3 level stand alone lateral surgery within next 6 months.

Who Is Running the Clinical Trial?

International Spine Study Group Foundation

Lead Sponsor

Trials

6

Recruited

1,600+

NuVasive

Industry Sponsor

Trials

46

Recruited

28,000+