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

This is an observational, prospective, non-randomized, non-controlled post-market surveillance study with optional retrospective enrollment of patients previously treated with the LORRAINE 2.5/3.5 mm Distal Humerus System.

The study will include adults with unilateral or bilateral distal humerus fractures requiring surgical fixation with locking plates and screws. The decision to treat a patient with the LORRAINE System is made by the treating surgeon as part of routine clinical care and independently of study participation. The study does not assign treatment or require experimental procedures. The LORRAINE System is used according to its cleared indications and Instructions for Use.

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.

Up to 100 participants will be enrolled. Enrollment will primarily be prospective, with optional retrospective enrollment of patients who have already undergone surgery. Retrospectively enrolled patients may be included if informed consent is obtained within the protocol-defined period and the required preoperative and operative information is available.

Participants will be followed for up to 12 months after surgery. Follow-up assessments are scheduled at approximately 6 weeks, 3 months, 6 months, and 12 months after surgery. Follow-up may be discontinued earlier if fracture healing is confirmed.

Assessments include clinical evaluation, radiographic evaluation, range of motion of the affected and contralateral elbows, pain assessment, the Mayo Elbow Performance Score, the EQ-5D-5L Health Questionnaire, and collection of adverse events and reoperations. Radiographs are required until fracture healing is confirmed by the investigator.

The primary outcome is radiographic and clinical fracture healing within 12 months after surgery. Radiographic fracture healing is defined as bridging callus or the absence of visible fracture lines on radiographs. Secondary outcomes include functional outcomes, quality of life, pain, radiographic findings, adverse events, reoperations, elbow range of motion, Mayo Elbow Performance Score, and EQ-5D-5L score.

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).