Retrospective Image Analysis of Degenerative Lumbar Disease Patients

NCT04886557 | Completed DMC

• 1 other identifier: 2017-10-008BC
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spondylolisthesis

Keywords

Dynesys dynamic stabilization, range of motion

Outcome Measures

Primary Outcomes (1)

• Range of motion

  The ROM change at index surgical level, supra-index level, and whole lumbar spine in degenerative lumbar diseased patients received dynesys dynamic instrumentation

  All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.

Secondary Outcomes (1)

• Screw loosening

  All patients completed the follow-up assessment at postoperative 1-, 2-, 3-, 6-, 12-, and 24-months.

Study Arms (1)

DDS fixation

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.

Procedure: L4-L5 decompression and dynamic instrumentation

Interventions

L4-L5 decompression and dynamic instrumentation PROCEDURE

All surgeries were performed by a senior surgeon using a traditional midline approach. Stability-preserving lumbar decompression with facet joint undercutting was performed to preserve the facet joints as much as possible. In cases of severe stenosis, a bilateral partial facetectomy (\< 25%) was performed for adequate decompression. Posterior tension of the supra- and inter-spinous ligaments was preserved at the most cranial level. Patients were encouraged to ambulate after drain removal and wear a soft lumbar orthosis for at least 3 months after the operation.

DDS fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with degenerative spondylolisthesis over L4-L5 who failed to respond to conservative treatment for at least 6 months and received Dynesys instrumentation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Publications (1)

• St-Pierre GH, Jack A, Siddiqui MM, Henderson RL, Nataraj A. Nonfusion Does Not Prevent Adjacent Segment Disease: Dynesys Long-term Outcomes With Minimum Five-year Follow-up. Spine (Phila Pa 1976). 2016 Feb;41(3):265-73. doi: 10.1097/BRS.0000000000001158.

  PMID: 26335675 RESULT

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 14, 2021
• Study Start: January 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2018
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)