Drug Delivery Devices for Osteomyelitis

Completed

• Conditions: Osteomyelitis
• Interventions: Device: antibiotic-loaded calcium sulfate; Device: antibiotic-loaded polymethyl methacrylate; Drug: Vancomycin

• Registration Number: NCT02968693
• Lead Sponsor: Yulin Orthopedics Hospital of Chinese and Western Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-25
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
combination therapy group	antibiotic-loaded calcium sulfate	antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin
combination therapy group	antibiotic-loaded polymethyl methacrylate	antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin
combination therapy group	Vancomycin	antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin
PMMA group	antibiotic-loaded polymethyl methacrylate	antibiotic-loaded polymethyl methacrylate and Vancomycin
PMMA group	Vancomycin	antibiotic-loaded polymethyl methacrylate and Vancomycin

Primary Outcome Measures

Name	Time	Method
complications after first-stage surgery.	through study completion, an average of 24 months.
local infection recurrence after first-stage surgery.	through study completion, an average of 24 months.

Trial Locations

Locations (2)

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China

Yulin Orthopedics Hospital of Chinese and Western Medicine; 🇨🇳 Yulin, Guangxi, China