Clinical trial NCT05953792: Selecting the SSV-1 as LIV in Scheuermann's Kyphosis
Official title: Selecting the Vertebra Above Sagittal Stable Vertebra as the Distal Fusion Level in Scheuermann's Kyphosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scheuermann's Kyphosis
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 74
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Global kyphosis (GK) in degrees
timeFrame: 24 months
measure: Lumbar lordosis (LL) in degrees
timeFrame: 24 months
measure: Sagittal vertical axis (SVA) in millimeters
timeFrame: 24 months
Secondary outcomes:
measure: Rates of distal junctional kyphosis
timeFrame: 24 months
measure: Scoliosis Research Society (SRS)-22 questionnaire
timeFrame: 24 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Drum Tower Hospital of Nanjing University Medical School
state: Jiang Su
Study officials:
References: