Intra-Articular or Extra-Articular Distal Humerus FractureNCT07774091
Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System
An observational study of Intra-Articular or Extra-Articular Distal Humerus Fracture and Distal Humerus Fracture, run by Bonebridge AG at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Articular or Extra-Articular Distal Humerus Fracture, Distal Humerus Fracture
- What is being tested?
- LORRAINE 2.5/3.5 mm Distal Humerus System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alex Greene contact
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Natasha Howard-White, +41798609620, celina.gmuer@bonebridge.ch
Stephen J Warner, MD, PhD, Associate Professor
About this study
Official title: LORRAINE 2.5/3.5 mm Distal Humerus System - Post-Market Surveillance Study
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.
Read the 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.
- Being tested
- LORRAINE 2.5/3.5 mm Distal Humerus System
- 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
- Medical subject headings
- Humeral Fractures, Distal, Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LORRAINE 2.5/3.5 mm Distal Humerus SystemDevice
Also called LORRAINE 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.
| Study group | Role | What they receive |
|---|---|---|
| LORRAINE Distal Humerus Fracture Cohort | Adults with unilateral or bilateral distal humerus fractures treated with the LORRAINE 2.5/3.5 mm Distal Humerus System according to the device's cleared indications and Instructions for Use.
Treatment consists of open reduction and internal fixation using locking plates and screws. 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 study does not assign treatment. The decision to use the LORRAINE System is made by the treating surgeon as part of routine clinical care and independently of study participation.
Participants are followed for up to 12 months after surgery to assess radiographic and clinical fracture healing, functional outcomes, quality of life, pain, radiographic findings, adverse events, and reoperations. Receives: Device: LORRAINE 2.5/3.5 mm Distal Humerus System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months after surgery
Secondary outcomes (6)
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.
Measured: From surgery through 12 months after surgery
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.
Measured: At 6 weeks, 3 months, 6 months, and 12 months after surgery, until fracture healing is confirmed
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.
Measured: 6 weeks, 3 months, 6 months, and 12 months after surgery
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.
Measured: 6 weeks, 3 months, 6 months, and 12 months after surgery
EQ-5D-5L Health-Related Quality-of-Life Index Score at Each Follow-up Visit
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.
Measured: 6 weeks, 3 months, 6 months, and 12 months after surgery
Pain Visual Analog Scale Score at Each Follow-up Visit
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.
Measured: 6 weeks, 3 months, 6 months, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Articular or Extra-Articular Distal Humerus FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bonebridge AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen J Warner, MD, PhD, Associate Professor, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774091
- Sponsor's protocol ID
- BB-PMCF-LORRAINE-US-2026
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified individual participant data will not be made publicly available or routinely shared with external researchers. No formal data-sharing framework or repository has been established for this sponsor-initiated post-market observational study. Study results may be reported in aggregate form to protect participant confidentiality and comply with applicable ethical, contractual, and data-protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LORRAINE 2.5/3.5 mm Distal Humerus System - Post-Market Surveillance Study
- ClinicalTrials.gov ID
- NCT07774091
- Acronym / sponsor ID
- BB-PMCF-LORRAINE-US-2026
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bonebridge AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LORRAINE Distal Humerus Fracture Cohort | – | Device: LORRAINE 2.5/3.5 mm Distal Humerus SystemAdults with unilateral or bilateral distal humerus fractures treated with the LORRAINE 2.5/3.5 mm Distal Humerus System according to the device's cleared indications and Instructions for Use. Treatment consists of open reduction and internal fixation using locking plates and screws. 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 study does not assign treatment. The decision to use the LORRAINE System is made by the treating surgeon as part of routine clinical care and independently of study participation. Participants are followed for up to 12 months after surgery to assess radiographic and clinical fracture healing, functional outcomes, quality of life, pain, radiographic findings, adverse events, and reoperations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LORRAINE 2.5/3.5 mm Distal Humerus SystemAlso: LORRAINE SystemThe 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. | Device | LORRAINE Distal Humerus Fracture Cohort |
Primary outcome
Number of Participants With Radiographic and Clinical Fracture Healing
Time frame: 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.
6 secondary outcomes
Number and Proportion of Participants With Adverse Events, Including Reoperations
Time frame: From surgery through 12 months after surgery
Number and Proportion of Participants With Clinically Relevant Radiographic Findings
Time frame: At 6 weeks, 3 months, 6 months, and 12 months after surgery, until fracture healing is confirmed
Affected and Contralateral Elbow Range of Motion at Each Follow-up Visit
Time frame: 6 weeks, 3 months, 6 months, and 12 months after surgery
Mayo Elbow Performance Score at Each Follow-up Visit
Time frame: 6 weeks, 3 months, 6 months, and 12 months after surgery
EQ-5D-5L Health-Related Quality-of-Life Index Score at Each Follow-up Visit
Time frame: 6 weeks, 3 months, 6 months, and 12 months after surgery
Pain Visual Analog Scale Score at Each Follow-up Visit
Time frame: 6 weeks, 3 months, 6 months, and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be made publicly available or routinely shared with external researchers. No formal data-sharing framework or repository has been established for this sponsor-initiated post-market observational study. Study results may be reported in aggregate form to protect participant confidentiality and comply with applicable ethical, contractual, and data-protection requirements.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex Greene contact
Stephen J Warner, MD, PhD, Associate Professor principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-Articular or Extra-Articular Distal Humerus Fracture and Distal Humerus Fracture, run by Bonebridge AG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celina Gmuer, MSc (0041798609620, celina.gmuer@bonebridge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Radiographic and Clinical Fracture Healing (time frame: Up to 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.