OsteomyelitisNCT02968693
Drug Delivery Devices for Osteomyelitis
An observational study of Osteomyelitis, run by Yulin Orthopedics Hospital of Chinese and Western Medicine at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 68 years
- Conditions the study is for
- Osteomyelitis
- What is being tested?
- antibiotic-loaded calcium sulfate, antibiotic-loaded polymethyl methacrylate and Vancomycin
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2011to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 68 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Other kinds of osteomyelitis.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Yulin Orthopedics Hospital of Chinese and Western Medicine
Yulin, Guangxi
About this study
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.
- Conditions
- Osteomyelitis
- Being tested
- antibiotic-loaded calcium sulfate, antibiotic-loaded polymethyl methacrylate, Vancomycin
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
VancomycinDrug
Vancomycin powder was added into the combination therapy group and PMMA groups
| Study group | Role | What they receive |
|---|---|---|
| combination therapy group | antibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin Receives: Device: antibiotic-loaded calcium sulfate; Device: antibiotic-loaded polymethyl methacrylate; Drug: Vancomycin | |
| PMMA group | antibiotic-loaded polymethyl methacrylate and Vancomycin Receives: Device: antibiotic-loaded polymethyl methacrylate; Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications after first-stage surgery.
Measured: through study completion, an average of 24 months.
local infection recurrence after first-stage surgery.
Measured: through study completion, an average of 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startApr 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yulin Orthopedics Hospital of Chinese and Western Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shanchao Luo, Yulin Orthopedics Hospital of Chinese and Western Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968693
- Sponsor's protocol ID
- 20150801c
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2016
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28007027
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Delivery Devices for Osteomyelitis
- ClinicalTrials.gov ID
- NCT02968693
- Acronym / sponsor ID
- 20150801c
- Conditions
- Osteomyelitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yulin Orthopedics Hospital of Chinese and Western MedicineUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination therapy group | – | Device: antibiotic-loaded calcium sulfate, Device: antibiotic-loaded polymethyl methacrylate, Drug: Vancomycinantibiotic-loaded calcium sulfate and antibiotic-loaded polymethyl methacrylate (PMMA) and Vancomycin |
| PMMA group | – | Device: antibiotic-loaded polymethyl methacrylate, Drug: Vancomycinantibiotic-loaded polymethyl methacrylate and Vancomycin |
Who may qualify
- Ages
- 15 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Other kinds of osteomyelitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibiotic-loaded calcium sulfateTo 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 | combination therapy group |
| antibiotic-loaded polymethyl methacrylateOne 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. | Device | PMMA group, combination therapy group |
| VancomycinVancomycin powder was added into the combination therapy group and PMMA groups | Drug | PMMA group, combination therapy group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Derived from this study: PubMed 28007027Luo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis, run by Yulin Orthopedics Hospital of Chinese and Western Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications after first-stage surgery. (time frame: through study completion, an average of 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02968693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.