Post-Operative Thoracolumosacral Orthosis for PJK

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30-75
SponsorHospital for Special Surgery, New York

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 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Align PJK™ TLSO brace
  • Standard of Care

Treatment groups

84 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hospital for Special Surgery, New York

Lead sponsor

Aspen Medical Products

Collaborator