Priority-Matching Correction Technique in Degenerative Lumbar Scoliosis

Not Applicable

Not yet recruiting

• Conditions: Degenerative Lumbar Disease; Degenerative Scoliosis; Scoliosis

• Registration Number: NCT06470165
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-24
• Last Update Posted: 2024-06-24
• Study Start: 2024-08-21
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oswestry disability index	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.
Achievement of minimal clinically important difference	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.
Scoliosis Research Society-22	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.

Trial Locations

Locations (1)

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China