Priority-Matching Correction Technique in Degenerative Lumbar Scoliosis (PMCTDLS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Scoliosis; Degenerative Scoliosis; Degenerative Lumbar Disease
• Intervention / Treatment: Procedure: Priority-matching correction technique in DLS; Procedure: Traditional correction technique in DLS

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shibao Lu; Phone Number: 18810728213; Email: wdfdoctor@126.com
• Study Contact Backup: Name: Dongfan Wang; Phone Number: 13821337116; Email: 1026607981@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital Capital Medical University
      • Contact: Dongfan Wang; Phone Number: 13821337116; Email: 1026607981@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DLS patients undergoing correction surgery in reference to our novel criteria; Correcting deformity according to the priority-matching correction technique.	Procedure: Priority-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.
Other: DLS patients undergoing correction surgery in reference to Obeid classification; Correcting deformity according to the standard proposed by Obeid and colleagues.	Procedure: Traditional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): August 21, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: xuanwu_DLS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No