Post-Operative Thoracolumosacral Orthosis for PJK
- Conditions
- Adult Spinal Deformity SurgeryProximal Junctional KyphosisThoracolumbosacral Orthosis
- Interventions
- Device: Align PJK™ TLSO braceOther: Standard of Care
- Registration Number
- NCT06491030
- Lead Sponsor
- Hospital for Special Surgery, New York
- Brief Summary
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 after spinal deformity surgery, however the efficacy of this in preventing PJK is unknown. This multi-center randomized control trial identified 84 patients undergoing thoracolumbosacral fusion for ASD and plans to study the efficacy of a novel post-operative TLSO in preventing the development of PJK as defined by the proximal junctional angle on 6-month post-operative X-rays.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thoracolumosacral Orthosis Align PJK™ TLSO brace Patients randomized to this arm will be fitted with an Aspen Medical Products "Align PJK™" TLSO brace. This is a 3-point, rigid hyperextension TLSO brace which is currently FDA approved under a 510k exemption but not commercially available. With this brace, the sternal pad height/width and belt component will be adjusted to optimize patient position and comfort. The brace will also be fitted with an external temperature sensing probe. Patients will be instructed to wear the brace at all times, including when in bed for 6-weeks post-operatively. At the 6-week visit patients will be asked to self-report compliance with the brace No brace Standard of Care Patients in the control arm will be treated without a brace but will have no other differences in their post-operative treatment protocol. This will be considered "usual care" for the purposes of this study.
- Primary Outcome Measures
Name Time Method The incidence of proximal junctional kyphosis development This 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.
- Secondary Outcome Measures
Name Time Method Change in patient reported outcome measures 6 week and 6-month time points Oswestry Disability Index (0-20% minimal disability; 21-40% moderate disability; 41-60% severe disability; 61-80 cripple, pain impinges on all aspects of life; 81-100% patients are bed bound)
Trial Locations
- Locations (6)
Indiana Spine Group
🇺🇸Carmel, Indiana, United States
University of Kansas
🇺🇸Overland Park, Kansas, United States
Hospital for Special Surgery
🇺🇸New York City, New York, United States
University of Texas Health, Houston
🇺🇸Bellaire, Texas, United States
Texas Back Institute
🇺🇸Dallas, Texas, United States
Virgina Mason Franciscan Health
🇺🇸Seattle, Washington, United States