Prospective Paired Evaluation of Conventional Versus Structured Magnetic Resonance Imaging Interpretation for Preoperative Assessment of Gluteal Permanent Synthetic Filler Disease

NCT07808463 | Not Yet Recruiting

• 1 other identifier: 007
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective paired diagnostic-impact study will compare conventional qualitative MRI reporting with a new structured anatomic classification in adults undergoing surgery for gluteal permanent synthetic filler disease. The structured report will document material effects across superficial, deep, muscular, regional, lymphatic, and interstitial compartments. Standardized intraoperative mapping will serve as the reference standard. The main outcome is the difference in sensitivity for surgically confirmed compartment involvement

Conditions

Foreign-Body Reaction; Soft Tissue Filler Complication; Gluteal Permanent Synthetic Filler Disease

Keywords

Biopolymers; Permanent Synthetic Fillers; Magnetic Resonance Imaging; Structured Reporting; Preoperative Planning; Gluteal Region

Outcome Measures

Primary Outcomes (1)

• Sensitivity for Surgically Confirmed Anatomic Compartment Involvement

  For each reporting method, sensitivity is the number of predefined compartments identified as involved on MRI divided by the number confirmed as involved during standardized intraoperative mapping. The structured and conventional results will be compared within the same participant.

  Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 days

Secondary Outcomes (3)

• Specificity for Surgically Uninvolved Anatomic Compartments

  Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 dys

• Change in Preoperative Surgical Plan After Structured MRI Review

  Immediately after the conventional report and immediately after the structured report, both before surgery. 1 day

• Surgeon-Rated MRI Report Utility

  Immediately after review of each preoperative MRI report. 1 day

Study Arms (1)

Paired MRI Interpretation Cohort

Each participant has the same MRI interpreted with the conventional qualitative format and with the structured anatomic classification before the index operation.

Diagnostic Test: Conventional Qualitative MRI Interpretation; Diagnostic Test: Structured Gluteal Filler MRI Classification; Procedure: Standardized Intraoperative Anatomic Mapping

Interventions

Conventional Qualitative MRI Interpretation DIAGNOSTIC_TEST

The report records the presence or absence of injected foreign material in the gluteal region and any routinely reported findings. A preliminary surgical plan is recorded after review of this report. Linked arm/group(s): Paired MRI Interpretation Cohort.

Paired MRI Interpretation Cohort

Standardized Intraoperative Anatomic Mapping PROCEDURE

During the index operation, the surgeon documents actual involvement of each predefined compartment before reviewing the imaging accuracy analysis. Operative photographs, specimen mapping, and histopathology may support the reference standard. Linked arm/group(s): Paired MRI Interpretation Cohort.

Paired MRI Interpretation Cohort

Structured Gluteal Filler MRI Classification DIAGNOSTIC_TEST

The report records material distribution and severity in predefined compartments: fat-fascia interface, subcutaneous fat, deep fascia, gluteal muscles, subcrestal region, ischial region, trochanteric region, pelvic ring, lymphatic pathways, and interstitial involvement. The final classification manual and grade definitions will be locked before enrollment. Linked arm/group(s): Paired MRI Interpretation Cohort.

Paired MRI Interpretation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with prior gluteal injection of permanent synthetic fillers who undergo preoperative pelvic/gluteal MRI and are scheduled for surgical removal or exploration.

You may qualify if:

• Age 18 years or older.
• History of gluteal injection with a permanent or unknown nonresorbable filler.
• Preoperative pelvic/gluteal MRI performed using the study acquisition protocol.
• Planned surgical removal, biopsy, or operative exploration within 90 days after MRI.
• Written informed consent for paired image interpretation and use of operative findings.

You may not qualify if:

• MRI contraindication or nondiagnostic imaging caused by motion or incomplete anatomic coverage.
• Prior extensive gluteal filler removal that prevents mapping of the predefined compartments.
• No operative procedure within 90 days after MRI and therefore no reference-standard assessment.
• Acute life-threatening infection or emergency surgery that prevents completion of the preoperative reporting sequence.
• Inability to provide consent.

Sponsors & Collaborators

• Research Inc: lead

Related Publications (5)

• Osorio E, Ramirez B, Herrera O, Suarez C, Ciro C, Varela A. Three-flap Technique: Comprehensive Approach for Biopolymer Removal in the Gluteal and Lumbar Regions. Plast Reconstr Surg Glob Open. 2026 Jul 23;14(7):e7870. doi: 10.1097/GOX.0000000000007870. eCollection 2026 Jul.

  PMID: 42495057 BACKGROUND

• Yahyavi-Firouz-Abadi N, Menias CO, Bhalla S, Siegel C, Gayer G, Katz DS. Imaging of cosmetic plastic procedures and implants in the body and their potential complications. AJR Am J Roentgenol. 2015 Apr;204(4):707-15. doi: 10.2214/AJR.14.13516.

  PMID: 25794060 BACKGROUND

• Niasme E, Delattre BMA, Lenoir V, Modarressi A, Poletti PA, Becker M, Boudabbous S. Quantitative magnetic resonance imaging: differentiating soft tissue implants and fillers used in cosmetic and reconstructive surgery. Skeletal Radiol. 2021 Jan;50(1):231-237. doi: 10.1007/s00256-020-03564-z. Epub 2020 Aug 5.

  PMID: 32761256 BACKGROUND

• Soliman SB. Liquid silicone filler migration following illicit gluteal augmentation. Radiol Case Rep. 2023 Jan 5;18(3):984-990. doi: 10.1016/j.radcr.2022.12.049. eCollection 2023 Mar.

  PMID: 36636483 BACKGROUND

• Leyva A, Tran T, Cibulas AT, Warden D, Danger FJ, Scherer K, Wasyliw C. Filler Migration and Granuloma Formation After Gluteal Augmentation with Free-silicone Injections. Cureus. 2018 Sep 13;10(9):e3294. doi: 10.7759/cureus.3294.

  PMID: 30443464 BACKGROUND

MeSH Terms

Conditions

Foreign-Body Reaction

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foreign Bodies; Wounds and Injuries

Study Officials

• Edison Osorio, MD, plastic surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edison Osorio, MD, Plastic surgeon

CONTACT

+573226140611; info@edisonosorio.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share