NCT02968693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

5.3 years

First QC Date

November 1, 2016

Last Update Submit

November 25, 2018

Conditions

Osteomyelitis

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (2)

combination therapy group

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

Device: antibiotic-loaded calcium sulfateDevice: antibiotic-loaded polymethyl methacrylateDrug: Vancomycin

PMMA group

antibiotic-loaded polymethyl methacrylate and Vancomycin

Device: antibiotic-loaded polymethyl methacrylateDrug: Vancomycin

Interventions

antibiotic-loaded calcium sulfateDEVICE

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.

combination therapy group
antibiotic-loaded polymethyl methacrylateDEVICE

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.

PMMA groupcombination therapy group
VancomycinDRUG

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

PMMA groupcombination therapy group

Eligibility Criteria

Age15 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Between April 2011 and April 2015, fifty-one patients requiring surgical treatment for chronic post-traumatic/postoperative osteomyelitis of the lower extremities were enrolled in a retrospective and control study in our hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • Other kinds of osteomyelitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Yulin Orthopedics Hospital of Chinese and Western Medicine

Yulin, Guangxi, China

Location

Related Publications (1)

  • Luo S, Jiang T, Yang Y, Yang X, Zhao J. Combination therapy with vancomycin-loaded calcium sulfate and vancomycin-loaded PMMA in the treatment of chronic osteomyelitis. BMC Musculoskelet Disord. 2016 Dec 22;17(1):502. doi: 10.1186/s12891-016-1352-9.

    PMID: 28007027DERIVED

MeSH Terms

Conditions

Osteomyelitis

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 18, 2016

Study Start

April 1, 2011

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 27, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)