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NCT Number: NCT06470165

Priority-Matching Correction Technique in Degenerative Lumbar Scoliosis

Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with degenerative lumbar scoliosis (DLS) who underwent correction surgery with reference to our priority-matching correction technique and the standard reported by Obeid and colleagues. Our findings may provide tangible guidance for surgical decision-making in DLS.

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Key information

Conditions

Degenerative Lumbar Disease Bone Diseases Degenerative Scoliosis Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location contact

Dongfan Wang

CONTACT

[email protected]

13821337116

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A diagnosis of DLS based on radiography and previous medical record,
  • Age > 50 years

Exclusion criteria

  • Leg length discrepancy,
  • A history of spinal or pelvic surgery,
  • A history of neuromuscular diseases, arthritis or tumor.

Treatment and study plan

Priority-matching correction technique in DLS

Procedure

For Type 1 global coronal malalignment (GCM), TL/L curve makes the primary contri- bution on C7PL shifting. First, inserting pedicle screws bilaterally. Second, aggressively decreasing the magnitude of TL/L curve. Third, moderately leveling L4 endplate to pull the fusion segments to the middle line with hand pressure on the convexity of TL/L curve. If the correctability of the key curve was limited, the correction of the minor curve would be con- vergent.

For Type 2 GCM, LS curve makes the primary contribution on C7PL shifting. First, releasing LS curve from the concave side using facetectomy after screws inserted. Second, performing L4-5 or L5-S1 trans- foraminal lumbar interbody fusion (TLIF) from the con- vexity of the fractional curve, with cages inserted at the concave side to assist deformity correction. Third, compressing the convexity of LS to horizontalize L4 endplate, followed by moderate manipulative reduction of TL/L curve to adjust intraoperative coronal balance.

Traditional correction technique in DLS

Procedure

In concave coronal malalignment (CM), the correction of the main curve improves the CM, thus we can talk about convergent corrective objectives. The ability to correct the CM depends on the correctability of the main curve. The need of three-column osteotomies in order to obtain correction of CM depends on the location and flexibility of the main curve.

The correction of convex CM depends on the correction of the lumbosacral curve. The correction strategy will depend on many factors including the driver of the deformity, which should always be fused, but also the degeneration and stiffness of the compensatory curve which can lead to more extended fusion. The need of three-column osteotomies depends mainly on the stiffness of the lumbosacral curve.

Primary outcomes

  1. Scoliosis Research Society-22

    Time frame: One month, 3 months, 6 months, 1 year, and 2 years after surgery

    The 22-item SRS-22r questionnaire is specific to scoliosis-related patient-reported outcomes, and consists of 6 domains: function, pain, self-image, mental health, satisfaction, and subtotal, with each domain being scored from 1 to 5 where higher scores correspond to better patient outcomes.

  2. Oswestry disability index

    Time frame: One month, 3 months, 6 months, 1 year, and 2 years after surgery

    The validated ODI is a self-administered questionnaire for evaluating back-specific functional disability, consisting of 10 items with scores from 0 to 5, and higher ODI indicates more severe disability.

  3. Achievement of minimal clinically important difference

    Time frame: Two years after surgery

    A prespecified MCID of 10 points was used for the ODI. The minimum clinically important difference (MCID) values for the SRS-22r based on data from a Japanese cohort have previously been reported as follows: function = 0.90, pain = 0.85, self-image = 1.05, mental health = 0.70, and subtotal = 1.05.

Study contacts

Contact information is provided by the study sponsor or research team.

Dongfan Wang

CONTACT

[email protected]

13821337116

Shibao Lu

CONTACT

[email protected]

18810728213

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Global Coronal Malalignment in Degenerative Lumbar Scoliosis and Priority-Matching Correction Technique to Prevent Postoperative Coronal Decompensation

Acronym: PMCTDLS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2024
Registry last updated
Jun 24, 2024

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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