Trials / Unknown
UnknownNCT04945434
Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis
Clinical Results of Chronic Cavitary Long-bone Osteomyelitis Treatment Using S53P4 Bioactive Glass; a Multi-center Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- Academisch Ziekenhuis Maastricht · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial studies the clinical effectiveness of S53P4 bioactive glass (BAG) as a bacterial growth inhibiting bone graft substitute in a one-stage or two-stage surgical procedure for treatment of chronic long bone osteomyelitis.
Detailed description
In this prospective multicenter study, patients from two different university hospitals in the Netherlands were included. Treatment consisted of debridement surgery, implantation of S53P4-BAG, if necessary wound closure by a plastic surgeon and additional culture based systemic antibiotics. Primary outcome was eradication of infection based on clinical presentation, radiographic imaging and laboratory tests. Secondary analysis was performed on probable risk factors for treatment failure after S53P4-BAG implantation.
Conditions
- Osteomyelitis
- Bone Infection
- Non-Union Fracture
- Bone Infection of Lower Leg
- Bone Infection of Pelvis, Hip, or Femur
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | S53P4 bioactive glass (BonAlive) | Surgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis. |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2020-06-30
- Completion
- 2021-06-30
- First posted
- 2021-06-30
- Last updated
- 2021-06-30
Source: ClinicalTrials.gov record NCT04945434. Inclusion in this directory is not an endorsement.