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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LORRAINE 2.5/3.5 mm Distal Humerus System — DEVICE
  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.

Study Details

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.

Key Dates

First listed

Aug 19, 2026

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Apr 30, 2028

Completion

Apr 30, 2028

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: LORRAINE Distal Humerus Fracture Cohort
  Adults with unilateral or bilateral distal humerus fractures treated with the LORRAINE 2.5/3.5 mm Distal Humerus System according to the device's cleared indications and Instructions for Use. Treatment consists of open reduction and internal fixation using locking plates and screws. 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 study does not assign treatment. The decision to use the LORRAINE System is made by the treating surgeon as part of routine clinical care and independently of study participation. Participants are followed for up to 12 months after surgery to assess radiographic and clinical fracture healing, functional outcomes, quality of life, pain, radiographic findings, adverse events, and reoperations.

Primary Outcome Measure

Number of Participants With Radiographic and Clinical Fracture Healing [ Time Frame: Up to 12 months after surgery ]

Central Contacts

• Celina Gmuer, MSc
  0041798609620
  [email protected]
• Alex Greene

Locations (1)

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