Recruiting

Thoracolumosacral Orthosis

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT06491030

Conditions

Proximal Junctional Kyphosis

Adult Spinal Deformity Surgery

Thoracolumbosacral Orthosis

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Align PJK™ TLSO brace

Standard of Care

Study Details

Brief 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

Study ID

NCT06491030

Start date

Dec 2, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Align PJK™ TLSO brace

Patients will get randomized to receiving and wearing a back brace for 6 weeks postoperatively.

Standard of Care

Patients will receive the standard of care postoperative instructions without a brace

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. ]

Central Contacts and Locations

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Rachel L Knopp

2126061723knoppr@hss.edu

Principal Investigator:

Han Jo Kim, MD

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Feb 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-02-13.