Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
1 other identifier
observational
171
1 country
1
Brief Summary
The main objective of this study is the external validation of the appropriateness criteria for the surgical treatment of Lumbar Degenerative Spondylolisthesis. We will assess, prospectively, whether patients treated "appropriately" have better outcomes than those treated "inappropriately" according to the RAND Appropriateness Method (RAM) Criteria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 14, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedAugust 9, 2021
August 1, 2021
4.7 years
November 14, 2016
August 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Core Outcome Measures Index
12-months Post-Treatment
Secondary Outcomes (5)
Oswestry Disability Index
12-months Post-Treatment
Global Outcome of Treatment Questions
12-months Post-Treatment
Satisfaction with Care
12-months Post-Treatment
Complications from Treatment
12-months Post-Treatment
Further Treatment after Initial Treatment
12-months Post-Treatment
Study Arms (1)
LDS Patients
All patients with a diagnosis of single-level Lumbar Degenerative Spondylolisthesis who present to the DHMC Spine Center.
Eligibility Criteria
Skeletally mature individuals with a primary pathology of single-level degenerative spondylolisthesis in the lumbar region of the spine.
You may qualify if:
- Is the patient skeletally mature with a primary pathology of single level degenerative spondylolisthesis in the lumbar region of the spine (with or without stenosis at other levels)?
- Able to give written informed consent
- Patient has already undertaken a course of non-operative care
You may not qualify if:
- Primarily degenerative scoliosis curvature greater than 15 degrees
- Presence of Isthmic Spondylolisthesis
- Cauda equine syndrome requiring immediate emergency surgery
- Active spinal infection, tumor, or unhealed fracture
- Inability to understand English
- Patient refused to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam M Pearson, MD
Dartmouth-Hitchcock Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
November 14, 2016
First Posted
November 17, 2016
Study Start
October 1, 2016
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
August 9, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share