MRI for acute proximal humeral fractures - Assessment of fracture geometry with an MRI application for imaging cortical bone surfaces (Part I) - Quantification of humeral head perfusion with Dynamic Contrast Enhanced MRI (Part II)

MRI for acute proximal humeral fractures - Assessment of fracture geometry with an MRI application for imaging cortical bone surfaces (Part I) - Quantification of humeral head perfusion with Dynamic Contrast Enhanced MRI (Part II) - Rostock MRI Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031380

Enrollment

Registered

2023-06-14

Start date

2023-07-16

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal humeral fracture

Interventions

Group 1: In study part I, 2 specialists each in radiology and trauma surgery/orthopedics will be presented with pseudonymized CT examinations with multiplanar reconstructions on the one hand and MRI e

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Acute proximal humerus fracture (max. 20 days) with indication for operative treatment by means of plate osteosynthesis (dislocated multifragmentary fractures of AO/OTA types 11A2.1, 11A2.2, 11A2.3, 11A3, 11B1.1, 11B1.2, 11C1.1, 11C1.3, 11C3.1, 11C3.2, 11C3.3) Patient's legal capacity, available written documentation of the informed consent interview and patient's consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients not capable of giving consent Contraindications for an MRI examination (claustrophobia, pacemaker, or other implants not compatible with an MRI, metal splinters, etc.) Contraindications for contrast medium administration (allergies, renal function impairment) Pregnancy/breastfeeding Previous surgery on the affected shoulder with inserted implants Manifest primary osteoarthritis of the shoulder or cuff arthropathy

Design outcomes

Primary

Measure	Time frame
Study Part I: The objective criterion is the validity of a novel MRI sequence, specifically designed to assess cortical bone structures, in the diagnosis of proximal humeral fractures. It is compared with CT as the gold standard. Two trauma surgeons and two radiologists will complete a questionnaire on fracture morphology and the presence of associated injuries and previous damage based on pseudonymized preoperative CT and MRI datasets. The data sets are from the patient collective of the overall study, but the evaluation will be performed independently of study part I in terms of time. Study Part II: The outcome criterion is the development of humeral head necrosis secondary to proximal humerus fracture. For this purpose, data or surrogate parameters will be collected at the following time points: T1 (up to 20 d after the accident, preoperatively): X-ray, CT, dynamic contrast MRI, bone metabolism laboratory, clinical scores. T2 (intraoperatively): Histology (punch biopsy from humeral head). T3 (3 months postoperatively): XR, CT, DCE-MRI, laboratory, clinical scores. T4 (6 months postoperatively): XR, CT, DCE-MRI, laboratory, clinical scores. In subjects without a fracture, only one dynamic MRI is performed.	—

Measure

Time frame

Study Part I: The objective criterion is the validity of a novel MRI sequence, specifically designed to assess cortical bone structures, in the diagnosis of proximal humeral fractures. It is compared with CT as the gold standard. Two trauma surgeons and two radiologists will complete a questionnaire on fracture morphology and the presence of associated injuries and previous damage based on pseudonymized preoperative CT and MRI datasets. The data sets are from the patient collective of the overall study, but the evaluation will be performed independently of study part I in terms of time. Study Part II: The outcome criterion is the development of humeral head necrosis secondary to proximal humerus fracture. For this purpose, data or surrogate parameters will be collected at the following time points: T1 (up to 20 d after the accident, preoperatively): X-ray, CT, dynamic contrast MRI, bone metabolism laboratory, clinical scores. T2 (intraoperatively): Histology (punch biopsy from humeral head). T3 (3 months postoperatively): XR, CT, DCE-MRI, laboratory, clinical scores. T4 (6 months postoperatively): XR, CT, DCE-MRI, laboratory, clinical scores. In subjects without a fracture, only one dynamic MRI is performed.

—

Secondary

Measure	Time frame
Proven Necrosis of the Humeral Head (MRI)	—

Countries

Germany

Contacts

Public ContactPatrick Gahr

Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsmedizin Rostock

patrick.gahr@med.uni-rostock.de017650429595

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026