Health TrialsbyHealthPanel

CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure

ConditionOsteomyelitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBONESUPPORT AB

About this trial

The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients receiving CERAMENT G subsequent to surgical excision of osteomyelitis, with Cierny-Mader classification grades III or IV, who require dead-space management of a bone defect following surgical debridement and excision of infection.

the presence of a sinus

the presence of an abscess or intra-operative pus

the presence of positive supportive histology

Disqualifiers

Skeletal immaturity, defined as pre-operative/ screening radiology with evidence of incompletely fused physes. (determined by their previous x-rays which are taken as part of their admission, unrelated to the study)

Those unable to give informed consent for inclusion in the trial, or those not willing to be included

A known allergy or reaction to gentamicin or calcium sulfate

Treatment with a combination of different antibiotic-eluting bone graft substitutes

Trial population

Patients enrolled post-operatively with Osteomyelitis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CERAMENT G

    Device

    CERAMENT G is intended for use as a bone void filler as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) as part of the surgical treatment of osteomyelitis. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing.

Treatment groups

128 Participants
are divided into 1 treatment group
Group A: CERAMENT G1 intervention

Trial outcomes

Primary outcomes

1

Composite Endpoint

Overall subject success requires all four of the following at 36 months post-op: * absence of a reinfection of the original site of osteomyelitis; * absence of purulent drainage and wound dehiscence/breakdown * absence of a secondary surgical intervention, e.g., grafting or removal of residual CERAMENT G at the original site; and, * a lack of serious adverse events associated with incomplete new bone formation, including pathologic fracture of the treated limb

Time frame
36 months
2

Co-Primary Endpoint

A trend showing increasing new bone formation and decreasing CERAMENT G as determined by a comparison of baseline and interim post-operative timepoint radiographic evaluations out to 36 months post-operative

Time frame
36 months

Secondary outcomes

1

Radiographic Succcess

Radiographic success at 36 months, defined as CERAMENT G resorption and new bone formation (a minimum of mean void-filling of 74% in the subject population) as determined by comparison of the immediate post-op radiographs to those at 36 months

Time frame
36 months
2

Clinical Success

Clinical success at 36 months, defined as: Maintenance or improvement in function (i.e., no decrease of PRO(s) in the SF-12 score between post-operative and 36 months follow-up)

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BONESUPPORT AB

Lead sponsor

Source ClinicalTrials.gov
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