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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Courtney Wright
- Telefonnummer: 614-366-8327
- E-post: Courtney.Wright@osumc.edu
Studera Kontakt Backup
- Namn: Aladdin AlQaisi
- Telefonnummer: 614-293-4876
- E-post: Aladdin.Alqaisi@osumc.edu
Studieorter
-
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University Health
-
Huvudutredare:
- David W Stockwell, MD, FAANS
-
-
Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55414
- University of Minnesota
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Huvudutredare:
- Ann Parr, MD, PhD
-
-
Ohio
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Columbus, Ohio, Förenta staterna, 43210
- The Ohio State University Wexner Medical Center Hospitals
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Kontakt:
- Aladdin AlQaisi
- Telefonnummer: 614-293-4876
- E-post: Aladdin.Alqaisi@osumc.edu
-
Huvudutredare:
- Bryan Ladd, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
-
≥ 18 years of age at the time surgery
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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
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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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: RETROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
UIV Screw Loosening Rate
Tidsram: 12-month follow-up
|
Rate of UIV screw loosening as assessed on x-rays |
12-month follow-up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adverse Events Associated with UIV Screws
Tidsram: 12-month follow-up
|
Adverse events reported that were related to the screws at the UIV |
12-month follow-up
|
|
Rate of Subsequent Surgical Intervention Involving the UIV
Tidsram: 12-month follow-up
|
Rate of subsequent surgical intervention including the UIV level |
12-month follow-up
|
|
Rate of UIV Screw Removal
Tidsram: 12-month follow-up
|
Rate of UIV screw removal |
12-month follow-up
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- BTNC-SI-BONE-UIV-2026-003
Plan för individuella deltagardata (IPD)
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