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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ENROLLING_BY_INVITATION
NA
200 participants
INTERVENTIONAL
2024-08-01
2025-08-01
Brief Summary
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The use of drains, however, are not without its disadvantages including the risk of retrograde infection, increased postoperative blood loss, increased length of stay and increased hospital costs. The purpose of this study is to evaluate the postoperative outcomes and complications in patients undergoing primary lumbar fusion with and without a postoperative drain
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1: Postoperative Drain Group
Participants will undergo their primary lumbar fusion spine surgery as planned and will have a drain placed postoperatively
Postoperative Drain Placement
These drains will be placed with the intention to decrease the incidence of postoperative hematoma
Group 2: No Postoperative Drain Group
Participants will undergo their primary lumbar fusion spine surgery as planned and will not have a drain placed postoperatively
No Postoperative Drain Placement
Participant will undergo lumbar spine fusion surgery and will not receive a postoperative drain
Interventions
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Postoperative Drain Placement
These drains will be placed with the intention to decrease the incidence of postoperative hematoma
No Postoperative Drain Placement
Participant will undergo lumbar spine fusion surgery and will not receive a postoperative drain
Eligibility Criteria
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Inclusion Criteria
* Undergoing primary lumbar fusion or decompression and fusion for 1-2 levels
* Surgery indicated for lumbar degenerative disease
Exclusion Criteria
* Surgery indicated for infection
* Intraoperative dural tear
* Surgery requiring intraoperative transfusion
18 Years
ALL
Yes
Sponsors
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Rothman Institute Orthopaedics
OTHER
Responsible Party
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Locations
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Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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2023-2934CKEP
Identifier Type: -
Identifier Source: org_study_id
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