Post-Operative Brace for Spinal Deformity Surgery
This study is looking at whether wearing a back brace (Align PJK™ TLSO brace) after surgery for adult spinal deformity (ASD) can help prevent a common problem called Proximal Junctional Kyphosis (PJK). PJK is when the spine curves abnormally above the area that was fused during surgery. While PJK doesn't always cause problems, it can sometimes get worse and require more surgery. Currently, it's common to use a brace after this type of surgery, but we don't know for sure if it helps prevent PJK. This study will involve 84 patients, aged 30 to 75, who are having their first spinal fusion surgery for ASD. You would either receive the Align PJK™ TLSO brace to wear for 6 weeks or follow standard post-operative care without a brace. The main goal is to see if the brace reduces the number of people who develop PJK, which will be checked with X-rays up to 6 months after surgery. The study's current recruitment status is unclear.
- Study design
- This is an interventional study that will randomly assign 84 participants to either wear a brace or receive standard care. It is a multi-center randomized control trial.
- What's involved
- Participants will either receive and wear a back brace for 6 weeks after surgery or follow standard post-operative instructions without a brace. X-rays will be taken before discharge, at 6 weeks, and at 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after surgery, with X-rays taken at pre-discharge, 6 weeks, and 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Post-Operative Thoracolumosacral Orthosis for PJK
At a glance
Conditions
NCT06491030
Where you'd take part
This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Hospital for Special Surgery
New York, New Yorkstudy coordinator listed
Recruiting
Indiana Spine Group
Carmel, Indianano site contact published
Active, not recruiting
Texas Back Institute
Dallas, Texasno site contact published
Active, not recruiting
University of Kansas
Overland Park, Kansasno site contact published
Active, not recruiting
University of Texas Health, Houston
Bellaire, Texasno site contact published
Active, not recruiting
Virgina Mason Franciscan Health
Seattle, Washingtonno site contact published
Active, not recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- The incidence of proximal junctional kyphosis developmentThis will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.
As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values.