Priority-Matching Correction Technique in Degenerative Lumbar Scoliosis

Not Applicable

Not yet recruiting

• Conditions: Degenerative Lumbar Disease; Degenerative Scoliosis; Scoliosis
• Interventions: Procedure: Traditional correction technique in DLS; Procedure: Priority-matching correction technique in DLS

• 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

Arm && Interventions

Group	Intervention	Description
DLS patients undergoing correction surgery in reference to Obeid classification	Traditional correction technique in DLS	Correcting deformity according to the standard proposed by Obeid and colleagues.
DLS patients undergoing correction surgery in reference to our novel criteria	Priority-matching correction technique in DLS	Correcting deformity according to the priority-matching correction technique.

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