Post-Operative Thoracolumosacral Orthosis for PJK

Hospital for Special Surgery (HSS)

Status and phase: Enrolling; Phase 4

Conditions: Proximal Junctional Kyphosis; Adult Spinal Deformity Surgery; Thoracolumbosacral Orthosis

Treatments: Other: Standard of Care; Device: Align PJK™ TLSO brace

Study type: Interventional

Funder types: Other

Identifiers

NCT06491030

2023-2446

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

84 participants in 2 patient groups, including a placebo group

Thoracolumosacral Orthosis

Experimental group

Description:

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

Treatment:

Device: Align PJK™ TLSO brace

No brace

Placebo Comparator group

Description:

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.

Treatment:

Other: Standard of Care