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CompletedNCT05953792

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

Selecting the Vertebra Above Sagittal Stable Vertebra as the Distal Fusion Level in Scheuermann's Kyphosis

Status
Completed
Phase
Study type
Observational
Enrollment
74 (actual)
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
Sex
All
Age
10 Years – 20 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDURESelect the vertebra above sagittal stable vertebra as the distal fusion levelThe 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.

Timeline

Start date
2018-01-01
Primary completion
2022-09-30
Completion
2022-12-31
First posted
2023-07-20
Last updated
2023-07-20

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05953792. Inclusion in this directory is not an endorsement.