Distal Humerus Fracture, Intra-Articular or Extra-Articular Distal Humerus Fracture
Conditions
Keywords
Distal Humerus Fracture, Elbow Fracture, Distal Humerus Fracture Fixation, Open Reduction and Internal Fixation, Internal Fixation, Locking Plate Fixation, Distal Humerus Plating, LORRAINE Distal Humerus System, Fracture Healing, Fracture Union, Elbow Range of Motion, Mayo Elbow Performance Score, EQ-5D-5L, Post-Market Surveillance, Distal Humerus Locking Plate System
Brief 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.
Detailed 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 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.
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.
Sponsors
Bonebridge AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Radiographic and Clinical Fracture Healing | Up to 12 months after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Proportion of Participants With Clinically Relevant Radiographic Findings | At 6 weeks, 3 months, 6 months, and 12 months after surgery, until fracture healing is confirmed | 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. |
| Affected and Contralateral Elbow Range of Motion at Each Follow-up Visit | 6 weeks, 3 months, 6 months, and 12 months after surgery | 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. |
| Mayo Elbow Performance Score at Each Follow-up Visit | 6 weeks, 3 months, 6 months, and 12 months after surgery | 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. |
| EQ-5D-5L Health-Related Quality-of-Life Index Score at Each Follow-up Visit | 6 weeks, 3 months, 6 months, and 12 months after surgery | Participant-reported general health status will be assessed using the EQ-5D-5L Health Questionnaire. Responses will be used to derive a health-related quality-of-life index score, with higher index scores generally indicating better health status. |
| Pain Visual Analog Scale Score at Each Follow-up Visit | 6 weeks, 3 months, 6 months, and 12 months after surgery | Pain will be assessed using the Visual Analog Scale as documented on the protocol-defined Follow-up Evaluation Form. Pain scores will be summarized at each scheduled follow-up visit. |
| Number and Proportion of Participants With Adverse Events, Including Reoperations | From surgery through 12 months after surgery | 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. |
Countries
United States
Contacts
CONTACTCelina Gmuer, MSc
CONTACTAlex Greene
PRINCIPAL_INVESTIGATORStephen J Warner, MD, PhD, Associate Professor
The University of Texas Health Science Center, Houston
Outcome results
None listed