Local Antibiotic Delivery From an Intramedullary Nail After Surgical Treatment of Tibial Fractures at High Risk of Infection (RESELUTE)
Local Antibiotic Delivery From an Intramedullary Nail After Surgical Treatment of Tibial Fractures at High Risk of Infection: A Multicenter, Prospective, Open-Label Clinical Trial (RESELUTE Study)
The goal of this clinical trial is to learn whether an antibiotic-releasing nail placed inside the shinbone (tibia) helps prevent infection and supports bone healing in adults with an open shinbone fracture. The study will test two versions of the Reselution Tibial Intramedullary Fixation System: one that releases vancomycin (Reselution V) and one that releases vancomycin and tobramycin (Reselution VT).
The main question it aims to answer is: within 12 months of surgery, how many participants heal without unplanned repeat surgery on the injured leg, have a healed bone on X-ray, and have no serious device-related side effects?
Participants will:
- Have surgery to fix their shinbone with the Reselution nail
- Have blood tests in the first 2 weeks after surgery (this testing may be stopped for later participants after an independent safety review)
- Attend follow-up visits for up to 24 months, including X-rays and questionnaires
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：SiNing Zhao, DrPh
- 電話番号：443-842-9704
- メール：szhao39@jh.edu
研究場所
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21201
- University of Maryland, Baltimore
-
主任研究者：
- Robert O'Toole, MD
-
コンタクト：
- Heather Phipps
- 電話番号：410-706-2492
- メール：HPhipps@som.umaryland.edu
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 22 to 80 years
- Open tibial shaft fracture, Gustilo-Anderson Type I, II, or IIIA, treated with intramedullary nail fixation (prior temporary fixation allowed)
- Adequate soft tissue coverage by primary closure or skin graft, without need for local or free flap
- Intramedullary nail placed within 14 days of injury
- Willing and able to comply with study procedures and follow-up
- Provides written informed consent
Exclusion Criteria:
- Gustilo-Anderson Type IIIB or IIIC fracture
- Fracture requiring more than one operative washout
- Bone defect of 1 cm or more
- Extensive contamination or muscle damage precluding fixation at initial debridement
- Fasciotomy wounds requiring skin grafting
- Infection at the fracture site at enrollment
- Fracture not amenable to intramedullary nailing with at least two proximal and two distal interlocking screws
- Displaced intra-articular tibial plateau or pilon fracture on the same limb
- Definitive fracture fixation before enrollment
- Planned staged bone grafting, cement spacer, or use of osteobiologics
- Chronic kidney disease with eGFR below 60 mL/min/1.73 m² or acute kidney injury requiring dialysis
- Calcium metabolism disorder
- Allergy or sensitivity to vancomycin, tobramycin, titanium, vanadium, aluminum, or calcium sulfate
- Pregnancy
- Endocrine or metabolic disorder affecting bone healing (osteoporosis allowed)
- Current use of systemic immunosuppressive, immunomodulatory (including systemic steroids), or chemotherapy agents
- Likely barriers to follow-up, such as severe psychiatric condition, cognitive impairment without family support, residence outside the catchment area, planned care elsewhere, incarceration, or homelessness
- Inadequate site resources to address low English literacy
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
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Reselution V
Definitive fixation of the open tibial fracture with the Reselution V Tibial Intramedullary Fixation System (vancomycin). |
Device-led combination product: titanium tibial intramedullary nail with an internal core loaded with vancomycin for local sustained antibiotic delivery. |
|
実験的：Reselution VT
Definitive fixation of the open tibial fracture with the Reselution VT Tibial Intramedullary Fixation System (vancomycin and tobramycin). |
Device-led combination product: titanium tibial intramedullary nail with an internal core loaded with vancomycin and tobramycin for local sustained antibiotic delivery. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants With Composite Success at 12 Months
時間枠：12 months after surgery
|
Composite success requires all of the following through 12 months: (1) no unplanned repeat surgery on the study injury for deep surgical site infection, to promote fracture union, for nail construct removal due to implant failure or migration, or amputation; (2) radiographic fracture union, defined as a modified Radiographic Union Score for Tibial fractures (mRUST) of 10 or greater; and (3) no device-related serious adverse events or device-related serious suspected adverse reactions. |
12 months after surgery
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants Without Unplanned Repeat Surgery
時間枠：12 and 24 months after surgery
|
Unplanned repeat surgery on the study injury to address infection, wound healing, or fracture union, excluding implant removal for prominence or irritation. |
12 and 24 months after surgery
|
|
Percentage of Participants With Radiographic Fracture Union
時間枠：12 months after surgery
|
Union defined as a modified Radiographic Union Score for Tibial fractures (mRUST) of 10 or greater. |
12 months after surgery
|
|
Percentage of Participants Without Device-Related Serious Adverse Events
時間枠：Through 12 and 24 months after surgery
|
Includes device-related serious adverse events and device-related serious suspected adverse reactions. |
Through 12 and 24 months after surgery
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score
時間枠：12 and 24 months after surgery
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (lower extremity) T-score. Higher scores indicate better function. |
12 and 24 months after surgery
|
|
Brief Pain Inventory Score
時間枠：12 and 24 months after surgery
|
Brief Pain Inventory scores range from 0 to 10. Higher scores indicate worse pain. |
12 and 24 months after surgery
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Score
時間枠：12 and 24 months after surgery
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities T-score. Higher scores indicate better ability to participate. |
12 and 24 months after surgery
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Robert O'Toole, MD、University of Maryland, Baltimore
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- RES-CT-001
- G260056 (その他の識別子：U.S. Food and Drug Administration (FDA) - Investigational Device Exemption (IDE))
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?
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
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