Post-Operative Thoracolumosacral Orthosis for PJK

PHASE4RecruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

December 2, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Proximal Junctional KyphosisAdult Spinal Deformity SurgeryThoracolumbosacral Orthosis
Interventions
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

Trial Locations (6)

10021

RECRUITING

Hospital for Special Surgery, New York

46032

ACTIVE_NOT_RECRUITING

Indiana Spine Group, Carmel

66211

ACTIVE_NOT_RECRUITING

University of Kansas, Overland Park

75243

ACTIVE_NOT_RECRUITING

Texas Back Institute, Dallas

77401

ACTIVE_NOT_RECRUITING

University of Texas Health, Houston, Bellaire

98101

ACTIVE_NOT_RECRUITING

Virgina Mason Franciscan Health, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aspen Medical Products

OTHER

lead

Hospital for Special Surgery, New York

OTHER

NCT06491030 - Post-Operative Thoracolumosacral Orthosis for PJK | Biotech Hunter | Biotech Hunter