Drug Delivery Devices for Osteomyelitis

Sponsor

Yulin Orthopedics Hospital of Chinese and Western Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02968693

Collaborator

(none)

Enrollment

Locations

Duration (Months)

25.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteomyelitis	Device: antibiotic-loaded calcium sulfate Device: antibiotic-loaded polymethyl methacrylate Drug: Vancomycin

Study Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
combination therapy group antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin	Device: antibiotic-loaded calcium sulfate To obtain a paste suitable for pellets, the following steps should be used: 1. Empty 10 cc Stimulan® calcium sulfate powder (Stimulan; Biocomposites Ltd; United Kingdom) into a sterile mixing bowl. 2. The calcium sulfate powder was mixed with 2,000 mg of vancomycin powder. 3. Add approximately 5 ml mixing solution into the above mixture. Mix thoroughly until a smooth paste is formed (approximately 30 seconds). 4. The resultant paste is uniformly smooth into the mould provided to form pellets with diameters of 4.8 mm and height of 3.3 mm. 5. Allow paste to cure undisturbed for at least 15 minutes after mixing. Flex mould to release pellets. Device: antibiotic-loaded polymethyl methacrylate One sachet of 40g PALACOSR®+G power containing 33.6g PMMA and with the addition of 0.5g gentamicin sulphate (Heraeus Medical Gesellschaft mit beschränkter Haftung,Germany) was mixed with 4,000 mg of vancomycin powder in a sterile bowl. The liquid provided was poured into the resultant mixture above. Then, the mixture was stirred carefully for 30 sec. If the dough-like mass no longer sticked to the rubber gloves, it can be progressed. If the required consistency was obtained, the cement can be applied to the bony defect until it hardened completely. Drug: Vancomycin Vancomycin powder was added into the combination therapy group and PMMA groups
PMMA group antibiotic-loaded polymethyl methacrylate and Vancomycin	Device: antibiotic-loaded polymethyl methacrylate One sachet of 40g PALACOSR®+G power containing 33.6g PMMA and with the addition of 0.5g gentamicin sulphate (Heraeus Medical Gesellschaft mit beschränkter Haftung,Germany) was mixed with 4,000 mg of vancomycin powder in a sterile bowl. The liquid provided was poured into the resultant mixture above. Then, the mixture was stirred carefully for 30 sec. If the dough-like mass no longer sticked to the rubber gloves, it can be progressed. If the required consistency was obtained, the cement can be applied to the bony defect until it hardened completely. Drug: Vancomycin Vancomycin powder was added into the combination therapy group and PMMA groups

Arm

Intervention/Treatment

combination therapy group

antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin

Device: antibiotic-loaded calcium sulfate

To obtain a paste suitable for pellets, the following steps should be used: 1. Empty 10 cc Stimulan® calcium sulfate powder (Stimulan; Biocomposites Ltd; United Kingdom) into a sterile mixing bowl. 2. The calcium sulfate powder was mixed with 2,000 mg of vancomycin powder. 3. Add approximately 5 ml mixing solution into the above mixture. Mix thoroughly until a smooth paste is formed (approximately 30 seconds). 4. The resultant paste is uniformly smooth into the mould provided to form pellets with diameters of 4.8 mm and height of 3.3 mm. 5. Allow paste to cure undisturbed for at least 15 minutes after mixing. Flex mould to release pellets.

Device: antibiotic-loaded polymethyl methacrylate

One sachet of 40g PALACOSR®+G power containing 33.6g PMMA and with the addition of 0.5g gentamicin sulphate (Heraeus Medical Gesellschaft mit beschränkter Haftung,Germany) was mixed with 4,000 mg of vancomycin powder in a sterile bowl. The liquid provided was poured into the resultant mixture above. Then, the mixture was stirred carefully for 30 sec. If the dough-like mass no longer sticked to the rubber gloves, it can be progressed. If the required consistency was obtained, the cement can be applied to the bony defect until it hardened completely.

Drug: Vancomycin

Vancomycin powder was added into the combination therapy group and PMMA groups

PMMA group

antibiotic-loaded polymethyl methacrylate and Vancomycin

Device: antibiotic-loaded polymethyl methacrylate

Drug: Vancomycin

Vancomycin powder was added into the combination therapy group and PMMA groups

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China	530021
2	Yulin Orthopedics Hospital of Chinese and Western Medicine	Yulin	Guangxi	China