NCT05953792|Completed
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
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Selecting the Vertebra Above Sagittal Stable Vertebra as the Distal Fusion Level in Scheuermann's Kyphosis
Sponsor study identifier
observational
74
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
September 30, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)September 30, 2022
Actual (reported)December 31, 2022
Actual (reported)July 2, 2023
Actual (reported)July 20, 2023
Actual (reported)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
Rates of distal junctional kyphosis
24 months
Scoliosis Research Society (SRS)-22 questionnaire
24 months
patients with their kyphotic apex located at T10 or above
patients with their kyphotic apex located below T10
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000, China
74 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2023
First Posted
July 20, 2023
Study Start
January 1, 2018
Actual (reported)Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
Contact the study team to confirm eligibility.
Primary Completion
September 30, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)Last Updated
July 20, 2023
Record last verified: 2023-07
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Source: ClinicalTrials.gov.
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