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Antibiotikum-Implantat für Osteomyelitis der Extremitäten – Pivotal-Studie - Genex mit Gentamicin. (ADOPT GG)

6. November 2026 aktualisiert von: Biocomposites Ltd

Eine multizentrische, einarmige, historisch kontrollierte Pivotal-Studie zur Bewertung der Sicherheit und Wirksamkeit von Genex G als Teil der chirurgischen Behandlung von Osteomyelitis der Extremitäten.

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

139

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: genex with gentamicin (genex G)

genex with gentamicin will be implanted during debridement surgery

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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)
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: Month 24

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Biocomposites Ltd

Ermittler

  • Studienleiter: Keira Watts, PHD, Biocomposites Ltd

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2027

Studienabschluss (Geschätzt)

1. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

26. November 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. November 2025

Zuerst gepostet (Tatsächlich)

8. Dezember 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. November 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 201924

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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