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

LORRAINE 2.5/3.5 mm Distal Humerus System - Post-Market Surveillance Study

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.

Inclusion Criteria:

• Patient must be 18 years of age or older
• Patient must have a distal humerus fracture requiring surgical intervention and be eligible for fixation by locking plate and screws
• Patient must have a fracture pattern requiring a minimum construct of the medial and posterolateral plates. Additional fragment plates may be used in addition as necessary.
• Unilateral or bilateral fractures.
• Patient must be capable of understanding the doctor's explanation, following the doctor's instruction, is able to and willing to complete the protocol required followup.
• Patient must have a signed IRB-approved informed consent.

Exclusion Criteria:

• Active infection
• Patients presenting conditions including blood supply limitations, insufficient quantity or quality of bone
• Foreign body sensitivity where material sensitivity is suspected; testing is to be completed prior to implantation of the device.
• Uncontrolled diabetes mellitus (e.g., investigator judgment or HbA1c above locally accepted surgical threshold).
• Current systemic immunosuppressive therapy or known immunodeficiency that may impair healing or increase infection risk.
• Morbid obesity (BMI ≥ 35 kg/m²) where, in the investigator's opinion, surgical risk or outcome assessment may be compromised.
• Patient known to be pregnant or breastfeeding.
• Patient is a current alcohol or drug abuser.
• Severe psychiatric disorder or cognitive impairment interfering with informed consent, protocol compliance, or follow-up.
• Likely problems with maintaining follow-up program (e.g., patient with no fixed address, long distance, plans to move during the course of study).
• Not expected to survive the duration of the follow-up program.
• Revision procedure at the target site (i.e., not a primary procedure).