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四肢骨髄炎向け抗生物質デバイス 決定的試験 - ゲンタマイシン配合ジェネックス (ADOPT GG)

2026年11月6日 更新者：Biocomposites Ltd

多施設共同、単一群、歴史的対照群による重要な臨床試験：四肢骨髄炎の外科的治療におけるGenex Gの安全性と有効性の評価

The purpose of this trial is to determine if genex with gentamicin (genex G) an antibiotic loaded bone void filler, works to treat and is a safe option as part of the surgical treatment of osteomyelitis in the extremities.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This trial is a multi-center, single arm, historically controlled, pivotal device study.

All participants diagnosed with osteomyelitis of the extremities (Cierny-Mader Classification grades I-IV) can be considered. All participants will undergo surgical debridement and will receive genex with gentamicin (genex G) antibiotic loaded bone void filler as part of the surgical treatment of osteomyelitis of the extremities. Participants will receive antibiotics per site specific requirements as clinically indicated. All participants will be followed up for 24 Months.

研究の種類

介入

入学 (推定)

139

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • California
      • San Diego、California、アメリカ、92104
        • まだ募集していません
        • North Park Podiatry
        • 主任研究者：
          • Trent Brookshier, DPM
        • コンタクト：
        • コンタクト：
    • Indiana
      • Indianapolis、Indiana、アメリカ、46278
    • Maryland
    • New Jersey
      • Oradell、New Jersey、アメリカ、07649
        • 募集
        • Curalta Clinical Trials
        • コンタクト：
        • 主任研究者：
          • Vincent Giacalone, DPM
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Patient with osteomyelitis of the extremities, who have failed antibiotic therapy and are requiring surgical intervention (unresolved osteomyelitis), Cierny-Mader classification of osteomyelitis grades I-IV. Patients presenting with Cierny-Mader grades I-II will be required to have a defect created as part of debridement surgery

  2. Patients at least 18 years of age *1

  3. Patient willing and able to provide written informed consent

  4. Patient geographically stable and able to comply with the required follow-up visits and testing schedule as assessed by the investigator

  5. Ability to achieve adequate surgical soft tissue coverage of the wound (primary tissue closure or surgical reconstruction including local and free soft tissue transfer)

    • 1 Patients between 18 and 22 years of age require confirmation of skeletal maturity as validated by radiographs of the bone to be treated.

Exclusion Criteria:

  1. Patients diagnosed with acute osteomyelitis
  2. Patients with Cierny-Mader grades I-II who are unable to have a defect created during debridement surgery
  3. Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg/dL (309umol/L) or being treated with dialysis
  4. Participants with a terminal or palliative diagnosis (e.g. terminal cancer diagnosis) deemed to have less than 1 year life expectancy by their health care team
  5. Uncontrolled diabetes mellitus (hemoglobin A1c levels >10%)
  6. Pre-existing calcium metabolism disorder
  7. Women who are pregnant or breastfeeding or planning on becoming pregnant during the study (a pregnancy test will be done in women of childbearing potential at screening and on the day of surgery)
  8. History of hypersensitivity or contraindication to the investigational device or any of its ingredients (calcium phosphate, β-tricalcium phosphate, and aminoglycoside antibiotics)
  9. Participation in an investigational drug/device study (within the last 60 days) or prior enrolment to the ADOPT GG study
  10. Clinically significant or unstable medical or surgical condition that in the investigators opinion may preclude safe and complete study participation (for example patients medically unfit for surgery, general anesthesia, or any risk of significant blood loss resulting in significant risk to loss of life)
  11. Current untreated malignant neoplasm(s), or current treatment with radiation therapy or chemotherapy
  12. Current or recent history (within last 2 years) of active substance abuse (e.g. recreational drugs, narcotics, or alcohol) that meets DSM-5 severe criteria
  13. Currently incarcerated

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Single Arm

Participants will receive genex with Gentamicin, an antibiotic loaded bone void filler that supports bone healing, as part of the surgical treatment of osteomyelitis of the extremities.
デバイス：genex with gentamicin (genex G)

genex with gentamicin will be implanted during debridement surgery

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
No further requirement for antibiotic treatment due to persisting symptoms of infection at the index site (i.e., additional antibiotics prescribed following completion of the initial systemic antibiotics prescribed post surgery.
時間枠：Month 12

Further requirement for antibiotic treatment due to persisting symptoms of infection at the site of treatment will be assessed at Month 12.
Month 12
No further surgical interventions required due to infection at the index site.
時間枠：Month 12

Need for further surgical interventions required due to infection at the index site will be assessed at Month 12.
Month 12
No recurrence of sinus formation at the index site.
時間枠：Month 12

Recurrence of sinus formation at the index site will be assessed by a non-contrast CT scan at week 2 & Month 12. Clinical endpoint assessments will also be used to measure this at post operative follow-up visits and will be assessed at Month 12.
Month 12

二次結果の測定

結果測定
メジャーの説明
時間枠
No additional requirement for antibiotic treatment due to persisting symptoms of infection at the treatment site, i.e., additional antibiotics prescribed following completion of the initial systemic antibiotics prescribed post-surgery.
時間枠：Month 24

Further requirement for antibiotic treatment due to persisting symptoms of infection at the site of treatment will be assessed at Month 24.
Month 24
No radiographic evidence of post op fractures.
時間枠：Month 24

Radiographic evidence of post-operative fractures will be evidenced by X-ray & CT evaluations and assessed at Month 24.
Month 24
Radiographic evidence of new bone healing.
時間枠：Month 24

Radiographic evidence of new bone healing will be evidenced by X-ray and CT evaluations and assessed at Month 24.
Month 24
No recurrence of sinus formation at the treatment site.
時間枠：Month 24

Recurrence of sinus formation at the index site will be assessed by contrast enhanced CT evaluation and Clinical endpoint assessments measured at Month 24.
Month 24
No secondary surgical interventions (SSI's) related to the investigational treatment.
時間枠：Month 24

Secondary Surgical interventions (SSI's) related to the investigational treatment will be assessed at Month 24.
Month 24
No serious adverse events that are definitely related to genex G.
時間枠：Month 24

Serious adverse events that are definitely related to genex G will be assessed at Month 24.
Month 24
Radiographic Evidence of new bone formation and product reabsorption.
時間枠：Month 24

Radiographic evidence of new bone formation and product reabsorption will be evidenced by X-ray and CT evaluations during the course of the trial and recorded on the participants electronic case report form (eCRF).
Month 24
Infection resolution evaluated by radiographic assessment and clinical endpoints.
時間枠：Month 24

Radiographic evidence of infection resolution will be evidenced by contrast enhanced CT evaluations and clinical endpoint assessments assessed during the course of the trial and recorded on the participants electronic case report form (eCRF).
Month 24
Adverse events including wound problems, reaction to combination product, fracture at treatment site.
時間枠：Month 24

Adverse events including wound problems, reaction to combination product, fracture at treatment site will be assessed during the course of the trial and recorded on the participants electronic case report form (eCRF).
Month 24
Secondary Surgical Interventions (SSI's)
時間枠：Month 24

Number of Secondary Surgical Interventions (SSI's) will be assessed during the course of the trial and recorded on the participants electronic case report form (eCRF).
Month 24
Number of participants discontinuing therapy prematurely due to a device related event.
時間枠：Month 24

Number of participants discontinuing therapy prematurely due to a device related event will be assessed during the course of the trial and recorded on the participants electronic case report form (eCRF).
Month 24
Number of hospitalisations/re-hospitalisation due to treatment site Osteomyelitis.
時間枠：Month 24

Number of hospitalisations/re-hospitalisation due to treatment site Osteomyelitis.
Month 24
Quality of Life EQ-5D-5L
時間枠：Month 24

Impact on the participants Quality of Life will be measured by the EQ-5D-5L during the course of the trial and recorded on the participants electronic case report form (eCRF).
Month 24

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Biocomposites Ltd

捜査官

  • スタディディレクター：Keira Watts, PHD、Biocomposites Ltd

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年10月20日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2028年10月1日

試験登録日

最初に提出

2025年11月26日

QC基準を満たした最初の提出物

2025年11月26日

最初の投稿 (実際)

2025年12月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月9日

QC基準を満たした最後の更新が送信されました

2026年11月6日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 201924

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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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