Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBonebridge AG
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- LORRAINE 2.5/3.5 mm Distal Humerus System
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov