Lumbar FusionNCT06536842
Wound Drain After Lumbar Fusion Surgery
A study testing Postoperative Drain Placement and No Postoperative Drain Placement in people with Lumbar Fusion, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Postoperative drain placement is often used following spine surgery. These drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Fusion
- What is being tested?
- Postoperative Drain Placement and No Postoperative Drain Placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18
- Undergoing primary lumbar fusion or decompression and fusion for 1-2 levels
- Surgery indicated for lumbar degenerative disease
Who cannot join
- Undergoing revision surgery
- Surgery indicated for infection
- Intraoperative dural tear
- Surgery requiring intraoperative transfusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Postoperative Outcomes Following Primary Lumbar Fusion in Patients With and Without a Drain: A Prospective Randomized Control Trial
Postoperative drain placement is often used following spine surgery. These drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression.
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
- Conditions
- Lumbar Fusion
- Being tested
- Postoperative Drain Placement, No Postoperative Drain Placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Drain PlacementOther
These drains will be placed with the intention to decrease the incidence of postoperative hematoma
No Postoperative Drain PlacementOther
Participant will undergo lumbar spine fusion surgery and will not receive a postoperative drain
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Postoperative Drain Group | Active comparator | Participants will undergo their primary lumbar fusion spine surgery as planned and will have a drain placed postoperatively Receives: Other: Postoperative Drain Placement |
| Group 2: No Postoperative Drain Group | Active comparator | Participants will undergo their primary lumbar fusion spine surgery as planned and will not have a drain placed postoperatively Receives: Other: No Postoperative Drain Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative complications
Incidence of postoperative complications will be measured but recording the number of emergency department visits
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536842
- Sponsor's protocol ID
- 2023-2934CKEP
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Outcomes Following Primary Lumbar Fusion in Patients With and Without a Drain: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06536842
- Acronym / sponsor ID
- 2023-2934CKEP
- Conditions
- Lumbar Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative drain placement is often used following spine surgery. These drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Postoperative Drain Group | Active comparator | Other: Postoperative Drain PlacementParticipants will undergo their primary lumbar fusion spine surgery as planned and will have a drain placed postoperatively |
| Group 2: No Postoperative Drain Group | Active comparator | Other: No Postoperative Drain PlacementParticipants will undergo their primary lumbar fusion spine surgery as planned and will not have a drain placed postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- Undergoing primary lumbar fusion or decompression and fusion for 1-2 levels
- Surgery indicated for lumbar degenerative disease
Key exclusion criteria (4 listed)
- Undergoing revision surgery
- Surgery indicated for infection
- Intraoperative dural tear
- Surgery requiring intraoperative transfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative Drain PlacementThese drains will be placed with the intention to decrease the incidence of postoperative hematoma | Other | Group 1: Postoperative Drain Group |
| No Postoperative Drain PlacementParticipant will undergo lumbar spine fusion surgery and will not receive a postoperative drain | Other | Group 2: No Postoperative Drain Group |
Primary outcome
Incidence of postoperative complications
Time frame: 1 year
Incidence of postoperative complications will be measured but recording the number of emergency department visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Drain Placement and No Postoperative Drain Placement in people with Lumbar Fusion, run by Rothman Institute Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative complications (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.