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Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System

20. august 2026 opdateret af: Bonebridge AG

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Alex Greene

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas Health Science Center at Houston
        • Ledende efterforsker:
          • Stephen J Warner, MD, PhD, Associate Professor
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Enhed: LORRAINE 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.

Andre navne:
  • LORRAINE System

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Radiographic and Clinical Fracture Healing
Tidsramme: 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.
Up to 12 months after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number and Proportion of Participants With Adverse Events, Including Reoperations
Tidsramme: 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.
From surgery through 12 months after surgery
Number and Proportion of Participants With Clinically Relevant Radiographic Findings
Tidsramme: 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.
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
Tidsramme: 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.
6 weeks, 3 months, 6 months, and 12 months after surgery
Mayo Elbow Performance Score at Each Follow-up Visit
Tidsramme: 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.
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
Tidsramme: 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.
6 weeks, 3 months, 6 months, and 12 months after surgery
Pain Visual Analog Scale Score at Each Follow-up Visit
Tidsramme: 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.
6 weeks, 3 months, 6 months, and 12 months after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bonebridge AG

Efterforskere

  • Ledende efterforsker: Stephen J Warner, MD, PhD, Associate Professor, The University of Texas Health Science Center, Houston

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. april 2028

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

14. august 2026

Først indsendt, der opfyldte QC-kriterier

14. august 2026

Først opslået (Faktiske)

19. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BB-PMCF-LORRAINE-US-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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