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

20. srpna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

100

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Alex Greene

Studijní místa

  • Spojené státy
    • Texas
      • Houston, Texas, Spojené státy, 77030
        • University of Texas Health Science Center at Houston
        • Vrchní vyšetřovatel:
          • Stephen J Warner, MD, PhD, Associate Professor
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Přístroj: 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.

Ostatní jména:
  • LORRAINE System

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Radiographic and Clinical Fracture Healing
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number and Proportion of Participants With Adverse Events, Including Reoperations
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Bonebridge AG

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. dubna 2028

Dokončení studie (Odhadovaný)

1. dubna 2028

Termíny zápisu do studia

První předloženo

14. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

14. srpna 2026

První zveřejněno (Aktuální)

19. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • BB-PMCF-LORRAINE-US-2026

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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