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Essai Pivotal sur le Dispositif Antibiotique pour l'Ostéomyélite des Extrémités - Genex avec Gentamicine. (ADOPT GG)

6 novembre 2026 mis à jour par: Biocomposites Ltd

Une étude pivot multicentrique, à bras unique, contrôlée historiquement, pour évaluer l'innocuité et l'efficacité de Genex G dans le cadre du traitement chirurgical de l'ostéomyélite des extrémités.

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

139

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: genex with gentamicin (genex G)

genex with gentamicin will be implanted during debridement surgery

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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.
Délai: 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.
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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)
Délai: 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.
Délai: 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.
Délai: Month 24

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Biocomposites Ltd

Les enquêteurs

  • Directeur d'études: Keira Watts, PHD, Biocomposites Ltd

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 octobre 2026

Achèvement primaire (Estimé)

1 octobre 2027

Achèvement de l'étude (Estimé)

1 octobre 2028

Dates d'inscription aux études

Première soumission

26 novembre 2025

Première soumission répondant aux critères de contrôle qualité

26 novembre 2025

Première publication (Réel)

8 décembre 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 novembre 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 201924

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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