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Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System

NCT07774091 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-08-21

No results posted yet for this study

Summary

Distal humerus fractures are fractures of the lower part of the upper arm bone near the elbow. These fractures often require surgery using plates and screws to stabilize the bone while it heals.

This observational study will evaluate adults with distal humerus fractures who are treated with the LORRAINE 2.5/3.5 mm Distal Humerus System as part of routine clinical care. The study does not assign or change the treatment selected by the treating surgeon.

Up to 100 participants will be enrolled and followed for up to 12 months after surgery. The study will evaluate radiographic and clinical fracture healing. It will also assess elbow function, range of motion, quality of life, pain, adverse events, radiographic findings, and reoperations.

Conditions

  • Intra-Articular or Extra-Articular Distal Humerus Fracture
  • Distal Humerus Fracture

Interventions

DEVICE

LORRAINE 2.5/3.5 mm Distal Humerus System

The LORRAINE 2.5/3.5 mm Distal Humerus System is an internal fixation system consisting of locking plates and screws used for open reduction and internal fixation of distal humerus fractures. For this study, the fixation construct includes, at minimum, a medial and a posterolateral plate. Additional fragment plates may be used as clinically necessary. LORRAINE 3.5 mm Extraarticular Distal Humerus Plates are excluded from the study. The decision to treat a patient with the LORRAINE System is made by the treating surgeon as part of routine clinical care and is not assigned by the study protocol. The device is used according to its cleared indications and Instructions for Use. Study participation does not alter the patient's surgical treatment.

Sponsors & Collaborators

  • Bonebridge AG

    lead INDUSTRY

Principal Investigators

  • Stephen J Warner, MD, PhD, Associate Professor · The University of Texas Health Science Center, Houston

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-04-30
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774091 on ClinicalTrials.gov