Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
25 participants
OBSERVATIONAL
2020-10-01
2023-12-31
Brief Summary
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Detailed Description
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The secondary endpoints are to analyze the safety and the patient's benefit of the Idys™ TLIF 3DTi by evaluating several point of view:
* The adverse events related to the surgery;
* The functional improvement between preoperative state and the different follow-up time points using the Oswestry Disability Index (ODI);
* The improvement of back pain between preoperative state and the different follow-up time points using the Visual Analog Scale (VAS) (legs and back);
* The evolution of several radiologic lumbar parameters to assess the correction and its stability.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Spine fusion surgery with Clariance Idys TLIF 3DTi
Posterior fusion of the lumbar spine with Clariance Idys TLIF 3DTi interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod).
Eligibility Criteria
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Inclusion Criteria
* Patient with skeletal maturity
* Patient with
* degenerative disc disease at one or two levels from L2 to S1 and/or
* grade 1 spondylolisthesis
* Surgical treatment with Idys TLIF 3DTi interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod).
Exclusion Criteria
* Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery.
* Any patient having a prior fusion at the level to be treated.
* Any patient being vulnerable
* Non-English speakers
18 Years
ALL
No
Sponsors
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Clariance
INDUSTRY
Responsible Party
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Principal Investigators
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Mukund Gundanna, Dr
Role: PRINCIPAL_INVESTIGATOR
Brazos Spine
Locations
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Brazos Spine
College Station, Texas, United States
Countries
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Other Identifiers
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31PMCF-DrG
Identifier Type: -
Identifier Source: org_study_id