Adult Spinal Deformity Surgery, Proximal Junctional Kyphosis, Thoracolumbosacral Orthosis
Conditions
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.
Interventions
DEVICEAlign PJK™ TLSO brace
Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively.
OTHERStandard of Care
Patients will receive the standard of care postoperative instructions without a brace
Sponsors
Hospital for Special Surgery, New York
Aspen Medical Products
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in patient reported outcome measures | 6 week and 6-month time points | VAS leg pain, and VAS back pain (scale of 0-10). 0= no pain; 10=worst possible pain |
Countries
United States
Outcome results
None listed