Priority-Matching Correction Technique in Degenerative Lumbar Scoliosis

NCT06470165 | Not Yet Recruiting

• 1 other identifier: xuanwu_DLS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Lumbar Disease; Scoliosis; Degenerative Scoliosis

Outcome Measures

Primary Outcomes (3)

• Scoliosis Research Society-22

  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.

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

• Oswestry disability index

  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.

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

• Achievement of minimal clinically important difference

  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.

  Two years after surgery

Study Arms (2)

DLS patients undergoing correction surgery in reference to our novel criteria

EXPERIMENTAL

Correcting deformity according to the priority-matching correction technique.

Procedure: Priority-matching correction technique in DLS

DLS patients undergoing correction surgery in reference to Obeid classification

OTHER

Correcting deformity according to the standard proposed by Obeid and colleagues.

Procedure: Traditional correction technique in DLS

Interventions

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.

DLS patients undergoing correction surgery in reference to our novel criteria

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.

DLS patients undergoing correction surgery in reference to Obeid classification

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Shibao Lu

CONTACT

18810728213; wdfdoctor@126.com

Dongfan Wang

CONTACT

13821337116; 1026607981@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)