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NCT Number: NCT05953792

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

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.

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Key information

Conditions

Scheuermann's Kyphosis Bone Diseases Kyphosis Musculoskeletal Diseases Osteochondrosis Scheuermann Disease Spinal Curvatures Spinal Diseases Spinal Osteochondrosis

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Global kyphosis (GK) in degrees

    Time frame: 24 months

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

  2. Lumbar lordosis (LL) in degrees

    Time frame: 24 months

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

  3. Sagittal vertical axis (SVA) in millimeters

    Time frame: 24 months

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

Secondary outcomes

  1. Rates of distal junctional kyphosis

    Time frame: 24 months

    record the incidence of the distal junctional kyphosis at the last follow-up. Distal junctional kyphosis was defined as a distal junctional angle ≥10˚, or a distal junctional angle ≥ 10˚ than the preoperative measurement

  2. Scoliosis Research Society (SRS)-22 questionnaire

    Time frame: 24 months

    The Scoliosis Research Society (SRS)-22 questionnaire is adopted to assess the patient-reported outcomes. The overall score can range from 22 to 110 points, and higher scores reflect better health status.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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