Drug Delivery Devices for Osteomyelitis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yulin Orthopedics Hospital of Chinese and Western Medicine
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- complications after first-stage surgery.
Overview
Brief Summary
Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of the lower extremities were included in the retrospective investigation. The patients were assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA. Hematological parameters, eradication of infection, rate of infection recurrence and reoperation rate were evaluated during the follow-up.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 15 Years to 68 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The retrospective study included patients with chronic post-traumatic or postoperative osteomyelitis and excluded patients suffering from hematogenous osteomyelitis or acute post-traumatic or postoperative osteomyelitis.
Exclusion Criteria
- •Other kinds of osteomyelitis.
Arms & Interventions
combination therapy group
antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin
Intervention: antibiotic-loaded calcium sulfate (Device)
combination therapy group
antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin
Intervention: antibiotic-loaded polymethyl methacrylate (Device)
combination therapy group
antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin
Intervention: Vancomycin (Drug)
PMMA group
antibiotic-loaded polymethyl methacrylate and Vancomycin
Intervention: antibiotic-loaded polymethyl methacrylate (Device)
PMMA group
antibiotic-loaded polymethyl methacrylate and Vancomycin
Intervention: Vancomycin (Drug)
Outcomes
Primary Outcomes
complications after first-stage surgery.
Time Frame: through study completion, an average of 24 months.
local infection recurrence after first-stage surgery.
Time Frame: through study completion, an average of 24 months.
Secondary Outcomes
No secondary outcomes reported
Investigators
Shanchao Luo
Director
Yulin Orthopedics Hospital of Chinese and Western Medicine