Post-Operative Thoracolumosacral Orthosis for PJK
Recruiting
Phase 4
Interventional Study
Proximal Junctional Kyphosis
Adult Spinal Deformity Surgery
Thoracolumbosacral Orthosis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 30 – 75
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 84 (estimated)
- Sponsor
- Hospital for Special Surgery, New York · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
Proximal junctional kyphosis (PJK) is a common post-operative radiographic finding after surgery for adult spinal deformity (ASD) patients. Although the clinical relevance of isolated PJK is unclear, PJK can progress to symptomatic proximal junctional failures which requires a large revision surgery. Currently, post-operative bracing with a thoracolumbosacral orthosis (TLSO) is common practice aft…
Trial Locations
Loading…
Loading trial locations…
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)
…
Contacts
No contact information available.