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Priority-Matching Correction Technique in Degenerative Lumbar Scoliosis

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06470165
Acronym
PMCTDLS
Enrollment
200
Registered
2024-06-24
Start date
2024-08-21
Completion date
2026-12-31
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Lumbar Disease, Degenerative Scoliosis, Scoliosis

Brief summary

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.

Interventions

PROCEDUREPriority-matching correction technique in DLS

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.

PROCEDURETraditional correction technique in DLS

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.

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. A diagnosis of DLS based on radiography and previous medical record, 2. Age > 50 years

Exclusion criteria

1. Leg length discrepancy, 2. A history of spinal or pelvic surgery, 3. A history of neuromuscular diseases, arthritis or tumor.

Design outcomes

Primary

MeasureTime frameDescription
Scoliosis Research Society-22One month, 3 months, 6 months, 1 year, and 2 years after surgeryThe 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.
Oswestry disability indexOne month, 3 months, 6 months, 1 year, and 2 years after surgeryThe 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.
Achievement of minimal clinically important differenceTwo years after surgeryA 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.

Countries

China

Contacts

Primary ContactShibao Lu
wdfdoctor@126.com18810728213
Backup ContactDongfan Wang
1026607981@qq.com13821337116

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026