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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Indiana
Indiana Spine Group
ACTIVE_NOT_RECRUITING
Carmel
Kansas
University of Kansas
ACTIVE_NOT_RECRUITING
Overland Park
New York
Hospital for Special Surgery
RECRUITING
New York
Texas
University of Texas Health, Houston
ACTIVE_NOT_RECRUITING
Bellaire
Texas Back Institute
ACTIVE_NOT_RECRUITING
Dallas
Washington
Virgina Mason Franciscan Health
ACTIVE_NOT_RECRUITING
Seattle
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 84
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Hospital for Special Surgery, New York
Collaborators: Aspen Medical Products

This content was sourced from clinicaltrials.gov