Thoracolumbar Spinal FusionREESENCT07838571
Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery
An observational study of Thoracolumbar Spinal Fusion, run by Ohio State University at 3 sites in United States.
Trial summary
The REESE study is looking at information from past spine surgeries to learn how often screws placed at the top of a spinal fusion become loose over time. Researchers will review existing medical records and X-rays from adults who have already had thoracolumbar spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracolumbar Spinal Fusion
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years of age) who previously underwent thoracolumbar spinal fusion with bilateral pedicle screw fixation at the upper instrumented vertebra (UIV), with or without pelvic fixation, and who have a minimum of 12 months of postoperative follow-up imaging. Eligible patients will be identified retrospectively from participating U.S. sites and evaluated for UIV screw loosening and related outcomes using existing clinical and radiographic records.
Who may be able to join
- ≥ 18 years of age at the time surgery
- Underwent thoracolumbar spinal fusion with bilateral screws at the UIV
- Construct <4 levels ending at the sacrum may be treated with or without pelvic fixation
- Constructs ≥4 levels ending at the sacrum must include pelvic fixation
- Constructs not ending at the sacrum may be included
- Patient must have a minimum of 12-month follow-up including imaging (AP and lateral x-rays)
Who cannot join
- Treated for high grade (grade III, IV, or V) spondylolisthesis
- Diagnosed with primary or metastatic tumor involving the spine, history of spinal malignancy, or active cancer at the time of surgery
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
The Ohio State University Wexner Medical Center Hospitals
Columbus, Ohio, 43210
Aladdin AlQaisi, 614-293-4876, Aladdin.Alqaisi@osumc.edu
Bryan Ladd, MD
Indiana University Health
Indianapolis, Indiana, 46202
David W Stockwell, MD, FAANS
University of Minnesota
Minneapolis, Minnesota, 55414
Ann Parr, MD, PhD
About this study
Official title: REESE - Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery
The REESE study is looking at information from past spine surgeries to learn how often screws placed at the top of a spinal fusion become loose over time. Researchers will review existing medical records and X-rays from adults who have already had thoracolumbar spinal fusion surgery. The study will also look at factors that may increase the risk of screw loosening and whether it leads to additional complications or surgeries. No new procedures, treatments, or patient visits are required because the study uses information that has already been collected during routine medical care.
Read the detailed description
The REESE (Retrospective Evaluation of Upper Instrumented Vertebrae Screw Loosening Following Spine Surgery) study is a multicenter, retrospective chart review that aims to determine the rate of screw loosening at the upper instrumented vertebra (UIV) following thoracolumbar spinal fusion surgery and identify associated risk factors. Up to 400 patients from up to 10 U.S. sites will be included. Eligible patients must be adults who underwent thoracolumbar fusion with bilateral UIV screws and have at least 12 months of postoperative imaging follow-up.
- Conditions
- Thoracolumbar Spinal Fusion
- Keywords
- UIV, Thoracolumbar Fusion, Upper Instrumented Vertebra, Proximal junctional kyphosis (PJK), proximal junctional failure (PJF), Spine Surgery, Screw Lucency, Pedicle Screw Loosening, Adult Spinal Deformity, Instrumentation Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thoracolumbar Fusion Cohort | Adults who underwent thoracolumbar spinal fusion with bilateral pedicle screw fixation at the upper instrumented vertebra (UIV) within the previous 5 years and had at least 12 months of postoperative follow-up imaging. Patients will be identified retrospectively from participating sites and evaluated for the incidence of UIV screw loosening and associated clinical and radiographic risk factors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
UIV Screw Loosening Rate
Rate of UIV screw loosening as assessed on x-rays
Measured: 12-month follow-up
Secondary outcomes (3)
Adverse Events Associated with UIV Screws
Adverse events reported that were related to the screws at the UIV
Measured: 12-month follow-up
Rate of Subsequent Surgical Intervention Involving the UIV
Rate of subsequent surgical intervention including the UIV level
Measured: 12-month follow-up
Rate of UIV Screw Removal
Rate of UIV screw removal
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracolumbar Spinal FusionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- SI-BONE, Inc.
- Responsible party
- Principal investigator, Bryan Ladd, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838571
- Sponsor's protocol ID
- BTNC-SI-BONE-UIV-2026-003
- Acronym
- REESE
- Status last verified
- Jul 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REESE - Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery
- ClinicalTrials.gov ID
- NCT07838571
- Acronym / sponsor ID
- REESE / BTNC-SI-BONE-UIV-2026-003
- Conditions
- Thoracolumbar Spinal Fusion
- Keywords
- UIV, Thoracolumbar Fusion, Upper Instrumented Vertebra, Proximal junctional kyphosis (PJK), proximal junctional failure (PJF), Spine Surgery, Screw Lucency, Pedicle Screw Loosening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- SI-BONE, Inc.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Sep 2026 (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.
The REESE study is looking at information from past spine surgeries to learn how often screws placed at the top of a spinal fusion become loose over time. Researchers will review existing medical records and X-rays from adults who have already had thoracolumbar spinal fusion surgery. The study will also look at factors that may increase the risk of screw loosening and whether it leads to additional complications or surgeries. No new procedures, treatments, or patient visits are required because the study uses information that has already been collected during routine medical care.
Detailed description
The REESE (Retrospective Evaluation of Upper Instrumented Vertebrae Screw Loosening Following Spine Surgery) study is a multicenter, retrospective chart review that aims to determine the rate of screw loosening at the upper instrumented vertebra (UIV) following thoracolumbar spinal fusion surgery and identify associated risk factors. Up to 400 patients from up to 10 U.S. sites will be included. Eligible patients must be adults who underwent thoracolumbar fusion with bilateral UIV screws and have at least 12 months of postoperative imaging follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracolumbar Fusion Cohort | – | –Adults who underwent thoracolumbar spinal fusion with bilateral pedicle screw fixation at the upper instrumented vertebra (UIV) within the previous 5 years and had at least 12 months of postoperative follow-up imaging. Patients will be identified retrospectively from participating sites and evaluated for the incidence of UIV screw loosening and associated clinical and radiographic risk factors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years of age) who previously underwent thoracolumbar spinal fusion with bilateral pedicle screw fixation at the upper instrumented vertebra (UIV), with or without pelvic fixation, and who have a minimum of 12 months of postoperative follow-up imaging. Eligible patients will be identified retrospectively from participating U.S. sites and evaluated for UIV screw loosening and related outcomes using existing clinical and radiographic records.
Key inclusion criteria (6 listed)
- ≥ 18 years of age at the time surgery
- Underwent thoracolumbar spinal fusion with bilateral screws at the UIV
- Patient must have a minimum of 12-month follow-up including imaging (AP and lateral x-rays)
Key exclusion criteria (2 listed)
- Treated for high grade (grade III, IV, or V) spondylolisthesis
- Diagnosed with primary or metastatic tumor involving the spine, history of spinal malignancy, or active cancer at the time of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
UIV Screw Loosening Rate
Time frame: 12-month follow-up
Rate of UIV screw loosening as assessed on x-rays
3 secondary outcomes
Adverse Events Associated with UIV Screws
Time frame: 12-month follow-up
Rate of Subsequent Surgical Intervention Involving the UIV
Time frame: 12-month follow-up
Rate of UIV Screw Removal
Time frame: 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracolumbar Spinal Fusion, run by Ohio State University at 3 sites 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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Wright (614-366-8327, Courtney.Wright@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UIV Screw Loosening Rate (time frame: 12-month follow-up). 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 24 Sep 2026.