Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Pivotaal onderzoek naar antibioticumapparaat voor osteomyelitis van de ledematen - Genex met gentamicine. (ADOPT GG)

6 november 2026 bijgewerkt door: Biocomposites Ltd

Een multicenter, single-arm, historisch gecontroleerd cruciale studie om de veiligheid en effectiviteit van Genex G te beoordelen als onderdeel van de chirurgische behandeling van osteomyelitis van de extremiteiten.

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

139

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: genex with gentamicin (genex G)

genex with gentamicin will be implanted during debridement surgery

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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)
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: Month 24

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Biocomposites Ltd

Onderzoekers

  • Studie directeur: Keira Watts, PHD, Biocomposites Ltd

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 oktober 2026

Primaire voltooiing (Geschat)

1 oktober 2027

Studie voltooiing (Geschat)

1 oktober 2028

Studieregistratiedata

Eerst ingediend

26 november 2025

Eerst ingediend dat voldeed aan de QC-criteria

26 november 2025

Eerst geplaatst (Werkelijk)

8 december 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 201924

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren