Can a new Plate-and-Screw system improve elbow fracture healing?
NCT ID NCT07774091
First seen Aug 19, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This study looks at how well a new plate-and-screw system, called LORRAINE, helps heal fractures of the lower part of the upper arm bone near the elbow. Adults with this type of fracture who receive the system during routine surgery will be followed for up to a year. Researchers will track bone healing, elbow movement, pain, quality of life, and any complications to see how the device performs in real-world use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LORRAINE 2.5/3.5 mm Distal Humerus System (locking plates and screws for internal fixation)
- What this could lead to
- If successful, this study could confirm the LORRAINE system as a reliable option for fixing distal humerus fractures, potentially improving healing and elbow function for patients.
- What could go wrong
- This is an observational study, so it cannot prove the device works better than others. Results may be affected by patient differences, and complications like infection or implant failure can still occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
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