Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery (REESE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thoracolumbar Spinal Fusion

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Courtney Wright; Phone Number: 614-366-8327; Email: Courtney.Wright@osumc.edu
• Study Contact Backup: Name: Aladdin AlQaisi; Phone Number: 614-293-4876; Email: Aladdin.Alqaisi@osumc.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health
      • Principal Investigator: David W Stockwell, MD, FAANS
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota
      • Principal Investigator: Ann Parr, MD, PhD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center Hospitals
      • Contact: Aladdin AlQaisi; Phone Number: 614-293-4876; Email: Aladdin.Alqaisi@osumc.edu
      • Principal Investigator: Bryan Ladd, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• ≥ 18 years of age at the time surgery

• Underwent thoracolumbar spinal fusion with bilateral screws at the UIV

  1. Construct <4 levels ending at the sacrum may be treated with or without pelvic fixation
  2. Constructs ≥4 levels ending at the sacrum must include pelvic fixation
  3. 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: RETROSPECTIVE

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UIV Screw Loosening Rate	Rate of UIV screw loosening as assessed on x-rays	12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Associated with UIV Screws	Adverse events reported that were related to the screws at the UIV	12-month follow-up
Rate of Subsequent Surgical Intervention Involving the UIV	Rate of subsequent surgical intervention including the UIV level	12-month follow-up
Rate of UIV Screw Removal	Rate of UIV screw removal	12-month follow-up

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: SI-BONE, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 18, 2026
• First Submitted That Met QC Criteria: September 18, 2026
• First Posted (Actual): September 24, 2026

Study Record Updates

• Last Update Posted (Actual): September 24, 2026
• Last Update Submitted That Met QC Criteria: September 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Spine Surgery; Adult Spinal Deformity; UIV; Thoracolumbar Fusion; Upper Instrumented Vertebra; Proximal junctional kyphosis (PJK); proximal junctional failure (PJF); Screw Lucency; Pedicle Screw Loosening; Instrumentation Failure
• Other Study ID Numbers: BTNC-SI-BONE-UIV-2026-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No