Post-Operative Thoracolumosacral Orthosis for PJK

Conditions

• Adult Spinal Deformity Surgery
• Proximal Junctional Kyphosis
• Thoracolumbosacral Orthosis

Eligibility Criteria

Sex

ALL

Age

30 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Align PJK™ TLSO brace — DEVICE
  Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively.
• Standard of Care — OTHER
  Patients will receive the standard of care postoperative instructions without a brace

Study Details

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.

Key Dates

Start date

Dec 2, 2024

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

84 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Thoracolumosacral Orthosis
  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
• Placebo Comparator: No brace
  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 Measure

The incidence of proximal junctional kyphosis development [ Time Frame: This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points. ]

Locations (6)

Find similar trials in Carmel, IN