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
This trial does not accept healthy volunteersQualifiers
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 population
Adults aged 18 years or older with unilateral or bilateral distal humerus fractures requiring surgical intervention who are eligible for fixation with locking plates and screws using the LORRAINE 2.5/3.5 mm Distal Humerus System and meet the protocol-defined eligibility criteria. Participants may be enrolled prospectively or through optional retrospective enrollment following surgery, provided that informed consent is obtained within the protocol-defined period and the required preoperative and operative information is available. Treatment with the LORRAINE System occurs as part of routine clinical care and is not assigned by the study protocol. Up to 100 participants will be enrolled and followed for up to 12 months after surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
LORRAINE 2.5/3.5 mm Distal Humerus System
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: LORRAINE Distal Humerus Fracture Cohort1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Radiographic and Clinical Fracture Healing
The number of participants with confirmed radiographic and clinical fracture healing following distal humerus fracture fixation with the LORRAINE 2.5/3.5 mm Distal Humerus System. Radiographic fracture healing is defined as bridging callus or the absence of visible fracture lines on radiographs. Clinical fracture healing is assessed by the investigator based on the clinical evaluation.
Time frame
Up to 12 months after surgerySecondary outcomes
1
Number and Proportion of Participants With Adverse Events, Including Reoperations
The number and proportion of participants experiencing one or more adverse events during the study. Adverse events will be assessed for seriousness and relationship to the LORRAINE System, its instrumentation, or the surgical procedure. Reoperations occurring during the follow-up period will also be recorded.
Time frame
From surgery through 12 months after surgery2
Number and Proportion of Participants With Clinically Relevant Radiographic Findings
The number and proportion of participants with clinically relevant radiographic findings, including fracture union status, nonunion, malunion, implant migration, implant breakage, or screw loosening, as assessed by the investigator on postoperative radiographs.
Time frame
At 6 weeks, 3 months, 6 months, and 12 months after surgery, until fracture healing is confirmed3
Affected and Contralateral Elbow Range of Motion at Each Follow-up Visit
Range of motion of the affected and contralateral elbows will be assessed at each scheduled follow-up visit. Measurements will be summarized separately for the affected and contralateral sides.
Time frame
6 weeks, 3 months, 6 months, and 12 months after surgery4
Mayo Elbow Performance Score at Each Follow-up Visit
Elbow function will be assessed using the Mayo Elbow Performance Score. The score evaluates pain, range of motion, stability, and daily function on a scale from 0 to 100, with higher scores indicating better elbow function. Scores below 60 are classified as poor, 60 to 74 as fair, 75 to 89 as good, and 90 to 100 as excellent.
Time frame
6 weeks, 3 months, 6 months, and 12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: