LORRAINE 2.5/3.5 mm Distal Humerus System - Post-Market Surveillance Study
Bonebridge AG
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.
Description
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 procedur…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 ha…
Interventions
- DeviceLORRAINE 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.
Location
- University of Texas Health Science Center at HoustonHouston, Texas