Minimally Invasive Surgery for Adult Spinal Deformity
(MIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of minimally invasive surgery for adults with complex spinal deformities (unusual spine shapes). It will assess the surgery's success by examining recovery, complications, and the need for additional surgery. The trial targets individuals diagnosed with specific spinal deformities who plan to undergo surgery on three or more spinal levels within the next six months. Those dealing with a complex spine issue and preparing for surgery soon may find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this surgical treatment is safe for complex adult spinal deformity patients?
Research shows that surgeries for complex adult spinal deformity (ASD) carry certain risks. Studies have found a high likelihood of complications, such as infections at the wound site during or after the operation. One study discovered that patients might sometimes require additional surgeries later on.
Efforts continue to make these procedures safer. Some programs work to lower risks and improve patient outcomes. Understanding that these surgeries are complex and challenging is crucial. However, with ongoing research and improvements, the goal is to make them safer and more effective for individuals with spinal problems.12345Why are researchers excited about this trial?
Researchers are excited about minimally invasive surgery for complex adult spinal deformity because it offers a less invasive option compared to traditional open surgeries. Unlike conventional methods that require larger incisions and longer recovery times, this approach uses percutaneous posterior spinal instrumentation or stand-alone lateral surgery, which involves smaller incisions and potentially faster recovery. This technique aims to reduce surgical trauma, minimize complications, and improve overall outcomes for patients with spinal deformities.
What evidence suggests that this surgical treatment is effective for complex adult spinal deformity?
Research has shown that surgery for adult spinal deformity (ASD) can greatly improve patients' quality of life. In this trial, participants will undergo either index or spine revision surgery for complex adult spinal deformity. Studies have found that these surgeries can enhance mobility and reduce pain. Patients have reported easier daily activities and improved health after surgery. The outcomes of these surgeries have been extensively studied, and many patients express satisfaction with the results. Although surgery carries risks, evidence strongly supports the potential benefits of improved movement and reduced pain.678910
Who Is on the Research Team?
Praveen Mummaneni, MD
Principal Investigator
University of San Francisco
Paul Park, MD
Principal Investigator
University of Michigan
Gregory Mundis, MD
Principal Investigator
Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CA
Juan Uribe, MD
Principal Investigator
Barrow Neurological Institute, Phoenix, AZ
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prehabilitation
Participants undergo prehabilitation, pain management, and mental health care to improve treatment outcomes
Treatment
Participants receive minimally invasive surgery for complex adult spinal deformity
Postoperative Care
Participants are monitored for surgical and postoperative complications, and outcomes are evaluated
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Index or Spine Revision Surgery for Complex Adult Spinal Deformity
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
International Spine Study Group Foundation
Lead Sponsor
NuVasive
Industry Sponsor
Citations
NCT04194138 | Complex Adult Deformity Surgery (CADS)
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and ...
Impact of spine surgery complications on costs associated ...
Approaches to clinical management of patients with adult spinal deformity (ASD) can be broadly categorized into nonoperative and operative care. Nonoperative ...
Outcomes of operative treatment for adult spinal deformity
OBJECTIVE. The current literature has primarily focused on the 2-year outcomes of operative adult spinal deformity (ASD) treatment.
Patient-Reported Outcomes After Adult Spinal Deformity ...
Background: Surgical treatment of adult spinal deformity (ASD) can significantly improve health-related quality of life (HRQoL) but is ...
Patient Reported Outcomes in Adult Spinal Deformity Surgery
Studies of outcomes in adult spinal deformity surgery (ASD) demonstrate treatment effectiveness and enable healthcare providers and patients to make informed ...
Perioperative Medical Complications in Adult Spine ...
Neurologic outcomes of complex adult spinal deformity surgery: results of the prospective, multicenter Scoli-RISK-1 study. Spine. 2016;41(3): ...
Revision Rate After Adult Deformity Surgery
Historically, surgical treatment of adult spinal deformity was limited by inadequate correction and high complication rates.
Quality metrics in adult spinal deformity surgery over the last ...
The reported rate of complications and cost of adult spinal deformity (ASD) surgery, associated with an exponential increase in the number of ...
9.
orangeflux.corp-images.net
orangeflux.corp-images.net/safetyinspine/wp-content/uploads/2017/11/Sethi_et_al_JNS_Spine_2017.pdfA systematic multidisciplinary initiative for reducing the risk of ...
spinal deformity (ASD) are challenging procedures with high rates of intraoperative and postoperative morbidity, including wound infections and ...
Complex Adult Deformity Surgery (CADS) - Clinical Trial Finder
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and ...
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