Selecting the SSV-1 as LIV in Scheuermann's Kyphosis

NCT05953792 | Completed

• 1 other identifier: 2021-LCYJ-DBZ-05
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The proper selection of the lowest instrumented vertebra (LIV) remains controversial in the surgical treatment of Scheuermann's disease and there is a paucity of studies investigating the clinical outcomes of fusion surgery when selecting the vertebra one level proximal to the sagittal stable vertebra (SSV-1) as LIV. The purpose of this study is to investigate whether SSV-1 could be a valid LIV for Scheuermann kyphosis (SK) patients with different curve patterns.

Conditions

Scheuermann's Kyphosis

Outcome Measures

Primary Outcomes (3)

• Global kyphosis (GK) in degrees

  Measured on anteroposterior and lateral radiographs and defined as the angle from upper to lower most tilted end vertebrae.

  24 months

• Lumbar lordosis (LL) in degrees

  Measured on anteroposterior and lateral radiographs and defined as the angle between the the superior end plate of L1 and S1

  24 months

• Sagittal vertical axis (SVA) in millimeters

  Measured on anteroposterior and lateral radiographs and defined as the horizontal distance between C7PL and the posterior superior corner of sacrum.

  24 months

Secondary Outcomes (2)

• Rates of distal junctional kyphosis

  24 months

• Scoliosis Research Society (SRS)-22 questionnaire

  24 months

Study Arms (2)

thoracic kyphosis

patients with their kyphotic apex located at T10 or above

Procedure: Select the vertebra above sagittal stable vertebra as the distal fusion level

thoracolumbar kyphosis

patients with their kyphotic apex located below T10

Procedure: Select the vertebra above sagittal stable vertebra as the distal fusion level

Interventions

Select the vertebra above sagittal stable vertebra as the distal fusion level PROCEDURE

The surgeries were performed by the same surgical team. Multi-level Ponte osteotomies were performed across the apex of the kyphosis after complete exposure of the spine, with resection of supra- and inter-spinous ligaments, ligamentum flavum, and the whole facet joints. After placement of the pedicle screws at the expected fusion levels, pre-contoured rods were attached to the screws followed by segmental compression. During rod placement, two to three rounds of compression in the area with Ponte osteotomies were employed to enhance kyphosis correction. Satellite rods were routinely added to long rods and implanted with duet screws. The final tightening was performed, and the posterior fusion was completed with a mixture of local and allogeneic bone. Due attention was given to preserving the posterior ligamentous structures at the upper and lower junctional areas.

thoracic kyphosis; thoracolumbar kyphosis

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A total of 36 SK patients (including 23 with TK and 13 patients with TLK) were included in this study, among which 29 were male, and 7 were female.

You may qualify if:

• diagnosis of SK patients;
• underwent one-stage posterior spinal fusion (PSF) with multi-level Ponte osteotomies;
• selecting SSV-1 as LIV;
• with a minimum follow-up of 2 years.

You may not qualify if:

• with previous spinal surgical history;
• with any other spinal deformities;
• without complete follow-up data.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Scheuermann Disease

Condition Hierarchy (Ancestors)

Spinal Osteochondrosis; Osteochondrosis; Bone Diseases; Musculoskeletal Diseases; Kyphosis; Spinal Curvatures; Spinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: July 20, 2023
• Study Start: January 1, 2018
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)