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

NCT ID: NCT05953792

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2022-12-31

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.

Detailed Description

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.

This was a prospective study on consecutive SK patients treated with posterior surgery between January 2018 and September 2020, in which the distal fusion level ended at SSV-1. The LIV was selected at SSV-1 only in patients with Risser > 2 and with LIV translation less than 40mm. All of the patients had a minimum of 2-year follow-up. Patients were further grouped based on the sagittal curve pattern as thoracic kyphosis (TK) and thoracolumbar kyphosis (TLK). Radiographic parameters including global kyphosis (GK), lumbar lordosis (LL), sagittal vertical axis (SVA), LIV translation, pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS) were measured preoperatively, postoperatively and at the latest follow-up. The intraoperative and postoperative complications were recorded. The Scoliosis Research Society (SRS)-22 scores were performed to evaluate clinical outcomes.

Conditions

Scheuermann's Kyphosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

thoracic kyphosis

patients with their kyphotic apex located at T10 or above

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

Intervention Type: 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.

thoracolumbar kyphosis

patients with their kyphotic apex located below T10

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2021-LCYJ-DBZ-05

Identifier Type: -

Identifier Source: org_study_id