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

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.

Study Overview

• Status: Recruiting
• Conditions: Proximal Junctional Kyphosis; Adult Spinal Deformity Surgery; Thoracolumbosacral Orthosis
• Intervention / Treatment: Device: Align PJK™ TLSO brace; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Active, not recruiting
      • Indiana Spine Group
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Active, not recruiting
      • University of Kansas
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Principal Investigator: Han Jo Kim, MD
      • Contact: Rachel L Knopp; Phone Number: 2126061723; Email: knoppr@hss.edu
  • Texas
    • Bellaire, Texas, United States, 77401
      • Active, not recruiting
      • University of Texas Health, Houston
    • Dallas, Texas, United States, 75243
      • Active, not recruiting
      • Texas Back Institute
  • Washington
    • Seattle, Washington, United States, 98101
      • Active, not recruiting
      • Virgina Mason Franciscan Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: Align PJK™ TLSO brace; Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively.
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.	Other: Standard of Care; Patients will receive the standard of care postoperative instructions without a brace

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of proximal junctional kyphosis development	As defined by a proximal junctional angle both ≥10° and 10°greater than pre-operative values.	This will be measured via scoliosis radiographs at the pre discharge, 6-week, and 6-month time points.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient reported outcome measures	VAS leg pain, and VAS back pain (scale of 0-10). 0= no pain; 10=worst possible pain	6 week and 6-month time points
Change in patient reported outcome measures	Oswestry Disability Index (0-20% minimal disability; 21-40% moderate disability; 41-60% severe disability; 61-80 cripple, pain impinges on all aspects of life; 81-100% patients are bed bound)	6 week and 6-month time points

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Collaborators: Aspen Medical Products

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Congenital Abnormalities; Kyphosis; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2023-2446

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes