NCT06491030

Post-Operative Thoracolumosacral Orthosis for PJK

The Use of a Novel Post-Operative Thoracolumosacral Orthosis for Prevention of Proximal Junctional Kyphosis After Adult Spinal Deformity Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2024-12-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-07-08
• Last updated: 2026-02-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study