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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Courtney Wright
- Telefonnummer: 614-366-8327
- E-post: Courtney.Wright@osumc.edu
Studer Kontakt Backup
- Navn: Aladdin AlQaisi
- Telefonnummer: 614-293-4876
- E-post: Aladdin.Alqaisi@osumc.edu
Studiesteder
-
-
Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Indiana University Health
-
Hovedetterforsker:
- David W Stockwell, MD, FAANS
-
-
Minnesota
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Minneapolis, Minnesota, Forente stater, 55414
- University of Minnesota
-
Hovedetterforsker:
- Ann Parr, MD, PhD
-
-
Ohio
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Columbus, Ohio, Forente stater, 43210
- The Ohio State University Wexner Medical Center Hospitals
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Ta kontakt med:
- Aladdin AlQaisi
- Telefonnummer: 614-293-4876
- E-post: Aladdin.Alqaisi@osumc.edu
-
Hovedetterforsker:
- Bryan Ladd, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
Inclusion Criteria:
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≥ 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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: RETROSPECTIVE
Kohorter og intervensjoner
Gruppe / 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
UIV Screw Loosening Rate
Tidsramme: 12-month follow-up
|
Rate of UIV screw loosening as assessed on x-rays |
12-month follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse Events Associated with UIV Screws
Tidsramme: 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
Tidsramme: 12-month follow-up
|
Rate of subsequent surgical intervention including the UIV level |
12-month follow-up
|
|
Rate of UIV Screw Removal
Tidsramme: 12-month follow-up
|
Rate of UIV screw removal |
12-month follow-up
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- BTNC-SI-BONE-UIV-2026-003
Plan for individuelle deltakerdata (IPD)
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