Post-Operative Thoracolumosacral Orthosis for PJK

Launched by HOSPITAL FOR SPECIAL SURGERY, NEW YORK · Jul 5, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a special type of back brace, called a thoracolumbosacral orthosis (TLSO), can help prevent a condition known as proximal junctional kyphosis (PJK) after surgery for spinal deformities in adults. PJK can sometimes lead to more serious problems that require additional surgeries, and the researchers want to see if wearing this brace after surgery can reduce the chances of developing PJK. The study will involve 84 patients who are having spinal fusion surgery and will compare the results of those who wear the brace to those who do not, looking at X-rays taken six months after surgery.

To be eligible for this trial, participants should be between 30 and 75 years old and scheduled for a specific type of spinal surgery that involves certain vertebrae in the back. However, those with certain health issues, such as severe osteoporosis or a high body mass index, as well as individuals needing revision surgeries or dealing with specific neuromuscular conditions, cannot participate. If you join the study, you can expect regular follow-ups and X-rays to monitor your recovery and the effectiveness of the brace. This trial aims to provide valuable insights into post-operative care for patients undergoing spinal surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 30-75-years-old
• • Undergoing primary thoracolumbosacral fusion for ASD with an upper instrumented vertebrae (UIV) between T8-L2 and lower instrumented vertebrae (LIV) of S1 or the ilium.
• Exclusion Criteria:
• • Osteoporosis (defined as a T-score \<-2.5 at the time of surgery)
• • Body mass index (BMI) \>35 kg/m2
• • Revision fusions
• • Fusions for trauma
• • Those with a neuromuscular etiology for their deformity (i.e. Parkinson's disease, cerebral palsy, post-stroke, etc.)
• • An underlying inflammatory arthropathy