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Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis

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ClinicalTrials.gov Identifier: NCT02966639
Recruitment Status : Active, not recruiting
First Posted : November 17, 2016
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Adam M. Pearson, Dartmouth-Hitchcock Medical Center

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.

Condition or disease
Spondylolisthesis

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 171 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
Study Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Group/Cohort
LDS Patients
All patients with a diagnosis of single-level Lumbar Degenerative Spondylolisthesis who present to the DHMC Spine Center.



Primary Outcome Measures :
  1. Core Outcome Measures Index [ Time Frame: 12-months Post-Treatment ]

Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 12-months Post-Treatment ]
  2. Global Outcome of Treatment Questions [ Time Frame: 12-months Post-Treatment ]
    Questions with 5 response categories, dichotomized to "good" and "poor"

  3. Satisfaction with Care [ Time Frame: 12-months Post-Treatment ]
    Questions with 5 response categories, dichotomized to "good" and "poor"

  4. Complications from Treatment [ Time Frame: 12-months Post-Treatment ]
    Questions with 5 response categories, dichotomized to "good" and "poor"

  5. Further Treatment after Initial Treatment [ Time Frame: 12-months Post-Treatment ]
    Questions with 5 response categories, dichotomized to "good" and "poor"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Skeletally mature individuals with a primary pathology of single-level degenerative spondylolisthesis in the lumbar region of the spine.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966639


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Adam M Pearson, MD Dartmouth-Hitchcock Medical Center

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Responsible Party: Adam M. Pearson, Staff Physician, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02966639     History of Changes
Other Study ID Numbers: D16174
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases