Retrospective Image Analysis of Degenerative Lumbar Disease Patients

Completed

• Conditions: Lumbar Spondylolisthesis
• Interventions: Procedure: L4-L5 decompression and dynamic instrumentation

• Registration Number: NCT04886557
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

The Dynesys dynamic stabilization (DDS) system is considered a motion-preserving device. However, studies addressing the change in the range of motion (ROM) are limited. Therefore, this study aimed to investigate the factors influencing ROM change at the index surgical level, supra-index level, and whole lumbar spine, in addition to the association between ROM preservation and the incidence of screw-loosening.

Detailed Description

Decompression with instrumented fusion is an effective surgical intervention for lumbar degenerative spondylolisthesis with spinal stenosis. However, the range of motion (ROM) decreased at the index surgical level may lead to an increased ROM at the non-surgical level, increase biomechanical stress at the transitional adjacent segment, and lead to adjacent segment degeneration (ASD) .

The Dynesys dynamic stabilization (DDS) system is a pedicle screw-based, motion-preserving, and non-fusion stabilization developed as an alternative to the rigid instrumented fusion for degenerative spondylolisthesis. The aim of the DDS is to maintain segmental motion at index levels and to reduce the incidence of ASD. However, the actual impact of ROM has remained elusive. Prior studies have reported an average ROM loss of 1.1º to 17.3º 7 at index surgical level at an average of 24 months follow-up.

The change of ROM at index surgical, supra-index, and whole lumbar spine following DDS remains unclear. This study aims to investigate the factors influencing the ROM change at index surgical level, supra-index level, and whole lumbar spine, and the association between ROM preservation and the incidence of screw-loosening.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2013-12
• Study Completion: 2018-12
• Status Verified: 2021-05
• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-12
• Last Update Submitted: 2021-05-12
• Study First Posted: 2021-05-14
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• Adult patients
• Diagnosed with degenerative spondylolisthesis over L4-L5
• Received DDS
• Received a minimum of 2-year follow-up were reviewed.

Exclusion Criteria

• presence of degenerative scoliosis or spinal deformity,
• prior spine surgery,
• lost to follow-up, or
• failure to complete the questionnaires or radiographic examinations.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DDS fixation	L4-L5 decompression and dynamic instrumentation	Adult patients with degenerative spondylolisthesis over L4-L5 received DDS with a minimum of 2-year follow-up were reviewed. Surgical indications were patients who failed to respond to conservative treatment for at least 6 months. The exclusion criteria were: (1) presence of degenerative scoliosis or spinal deformity, (2) prior spine surgery, (3) lost to follow-up, or (4) failure to complete the questionnaires or radiographic examinations.

Primary Outcome Measures

Name	Time	Method
Range of motion	All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.	The ROM change at index surgical level, supra-index level, and whole lumbar spine in degenerative lumbar diseased patients received dynesys dynamic instrumentation

Secondary Outcome Measures

Name	Time	Method
Screw loosening	All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.	Radiographic screw-loosening was defined as presence of a halo or double-halo sign on plain x-ray films

Trial Locations

Locations (1)

Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan