Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Celina Gmuer, MSc
- 電話番号：0041798609620
- メール：celina.gmuer@bonebridge.ch
研究連絡先のバックアップ
- 名前：Alex Greene
研究場所
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Texas
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Houston、Texas、アメリカ、77030
- University of Texas Health Science Center at Houston
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主任研究者：
- Stephen J Warner, MD, PhD, Associate Professor
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コンタクト：
- Natasha Howard-White
- 電話番号：+41798609620
- メール：celina.gmuer@bonebridge.ch
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
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.
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Radiographic and Clinical Fracture Healing
時間枠：Up to 12 months after surgery
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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.
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Up to 12 months after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number and Proportion of Participants With Adverse Events, Including Reoperations
時間枠：From surgery through 12 months after surgery
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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.
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From surgery through 12 months after surgery
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Number and Proportion of Participants With Clinically Relevant Radiographic Findings
時間枠：At 6 weeks, 3 months, 6 months, and 12 months after surgery, until fracture healing is confirmed
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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.
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At 6 weeks, 3 months, 6 months, and 12 months after surgery, until fracture healing is confirmed
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Affected and Contralateral Elbow Range of Motion at Each Follow-up Visit
時間枠：6 weeks, 3 months, 6 months, and 12 months after surgery
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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.
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6 weeks, 3 months, 6 months, and 12 months after surgery
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Mayo Elbow Performance Score at Each Follow-up Visit
時間枠：6 weeks, 3 months, 6 months, and 12 months after surgery
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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.
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6 weeks, 3 months, 6 months, and 12 months after surgery
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EQ-5D-5L Health-Related Quality-of-Life Index Score at Each Follow-up Visit
時間枠：6 weeks, 3 months, 6 months, and 12 months after surgery
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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.
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6 weeks, 3 months, 6 months, and 12 months after surgery
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Pain Visual Analog Scale Score at Each Follow-up Visit
時間枠：6 weeks, 3 months, 6 months, and 12 months after surgery
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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.
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6 weeks, 3 months, 6 months, and 12 months after surgery
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Stephen J Warner, MD, PhD, Associate Professor、The University of Texas Health Science Center, Houston
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- BB-PMCF-LORRAINE-US-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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