Long-term study of the LORRAINE plate and screw system for distal humerus fracture healing

You may qualify if

• 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.

You can't join if

• 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).