InfectionNCT02107924
Use of Antibiotic Carrier in Acute Periprosthetic Infections (APPI) of Total Knee Replacements
An observational study of Infection, run by Michael Muldoon, M.D. at 1 site in United States.
Trial summary
The purpose of the study is to gather information on the use of Stimulan, the surgery, and anitbiotics to whetether the APPI has decreased or shown improvement when compared to study participants who did not receive Stimulan during their revision total knee replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- APPI of TKR-Stimulan
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total knee replacement and have developed either APPI within 28 dyas of surgery, or an acute onset of a hematogenous (blood-source ) infection in knee, more than 30 days after surgery with symptoms present less than 28 days
Who may be able to join
- APPI within 28 days of primary TKR
- Acute hematogenous infection within 4 weeks of symptoms
Who cannot join
- Exposed prosthesis
- Infection occuring in revised joints
- Poly articular infections
- have allergies to tobramycin or Vancomycin
- previous chronic infections in or around any ipsilateral extremity trauma or implants
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Orthopedic Group, LLP
Houston, Texas, 77030
About this study
Official title: Use of Antibiotic Contained Calcium Sulfate Carrier in Acute Periprosthetic Infections(APPI) of Total Knee Replacements
The purpose of the study is to gather information on the use of Stimulan, the surgery, and anitbiotics to whetether the APPI has decreased or shown improvement when compared to study participants who did not receive Stimulan during their revision total knee replacement surgery.
- Conditions
- Infection
- Being tested
- APPI of TKR-Stimulan
- Keywords
- Total, Knee, Replacment, Infection, Stimulan
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APPI of TKR-StimulanProcedure or surgery
Also called Stimulan, Tobramycin, Vancomycin
| Study group | Role | What they receive |
|---|---|---|
| APPI of TKR-Stimulan | Surgery Stimulan beads 2.4 G Tobramycin 2.0 G Vancomycin Receives: Procedure: APPI of TKR-Stimulan | |
| APPI of TKR-historical | Surgery 2.4 G Tobramycin 2.0 G Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of components
Measured: 12 months
Eradication of infection
Measured: 12 months
Secondary outcomes (9)
C-Reactive protein (CRP)
Measured: 12 months
Wound complications
Measured: 12 months
Knee Society Score
Measured: 12 months
Visual Analog Scale
Measured: 12 months
Outcome Assessment Scores
Measured: 12 months
Ongoing use of antibiotics
Measured: 6 weeks
AP and lateral Radiographs of involved joint
Measured: 12 months
Positive synovial fluid cell count
Measured: pre-operative
Sedimentation Rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: No Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Muldoon, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Responsible party
- Sponsor-investigator, Michael Muldoon, M.D., Sharp HealthCare
- Investigators
- Michael P Muldoon, MD, Principal investigator, Sharp HealthCareDavid R Lionberger, MD, Principal investigator, Southwest Orthopedic Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107924
- Sponsor's protocol ID
- 1112-0211
- Status last verified
- Nov 2014
- First submitted
- 4 Apr 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Parvizi J, Zmistowski B, Berbari EF, Bauer TW, Springer BD, Della Valle CJ, Garvin KL, Mont MA, Wongworawat MD, Zalavras CG. New definition for periprosthetic joint infection: from the Workgroup of the Musculoskeletal Infection Society. Clin Orthop Relat Res. 2011 Nov;469(11):2992-4. doi: 10.1007/s11999-011-2102-9. No abstract available.
PubMed 21938532Mortazavi SM, Vegari D, Ho A, Zmistowski B, Parvizi J. Two-stage exchange arthroplasty for infected total knee arthroplasty: predictors of failure. Clin Orthop Relat Res. 2011 Nov;469(11):3049-54. doi: 10.1007/s11999-011-2030-8.
PubMed 21866421Koyonos L, Zmistowski B, Della Valle CJ, Parvizi J. Infection control rate of irrigation and debridement for periprosthetic joint infection. Clin Orthop Relat Res. 2011 Nov;469(11):3043-8. doi: 10.1007/s11999-011-1910-2.
PubMed 21553171Gardner J, Gioe TJ, Tatman P. Can this prosthesis be saved?: implant salvage attempts in infected primary TKA. Clin Orthop Relat Res. 2011 Apr;469(4):970-6. doi: 10.1007/s11999-010-1417-2.
PubMed 20544317Estes CS, Beauchamp CP, Clarke HD, Spangehl MJ. A two-stage retention debridement protocol for acute periprosthetic joint infections. Clin Orthop Relat Res. 2010 Aug;468(8):2029-38. doi: 10.1007/s11999-010-1293-9.
PubMed 20224958
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Antibiotic Contained Calcium Sulfate Carrier in Acute Periprosthetic Infections(APPI) of Total Knee Replacements
- ClinicalTrials.gov ID
- NCT02107924
- Acronym / sponsor ID
- 1112-0211
- Conditions
- Infection
- Keywords
- Total, Knee, Replacment, Infection, Stimulan
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Michael Muldoon, M.D.University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Apr 2014 (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.
The purpose of the study is to gather information on the use of Stimulan, the surgery, and anitbiotics to whetether the APPI has decreased or shown improvement when compared to study participants who did not receive Stimulan during their revision total knee replacement surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APPI of TKR-Stimulan | – | Procedure: APPI of TKR-StimulanSurgery Stimulan beads 2.4 G Tobramycin 2.0 G Vancomycin |
| APPI of TKR-historical | – | –Surgery 2.4 G Tobramycin 2.0 G Vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total knee replacement and have developed either APPI within 28 dyas of surgery, or an acute onset of a hematogenous (blood-source ) infection in knee, more than 30 days after surgery with symptoms present less than 28 days
Key inclusion criteria (2 listed)
- APPI within 28 days of primary TKR
- Acute hematogenous infection within 4 weeks of symptoms
Key exclusion criteria (5 listed)
- Exposed prosthesis
- Infection occuring in revised joints
- Poly articular infections
- have allergies to tobramycin or Vancomycin
- previous chronic infections in or around any ipsilateral extremity trauma or implants
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 |
|---|---|---|
| APPI of TKR-StimulanAlso: Stimulan, Tobramycin, Vancomycin | Procedure or surgery | APPI of TKR-Stimulan |
Primary outcome
Retention of components
Time frame: 12 months
Eradication of infection
Time frame: 12 months
9 secondary outcomes
C-Reactive protein (CRP)
Time frame: 12 months
Wound complications
Time frame: 12 months
Knee Society Score
Time frame: 12 months
Visual Analog Scale
Time frame: 12 months
Outcome Assessment Scores
Time frame: 12 months
Ongoing use of antibiotics
Time frame: 6 weeks
AP and lateral Radiographs of involved joint
Time frame: 12 months
Positive synovial fluid cell count
Time frame: pre-operative
Sedimentation Rate
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
- Background: PubMed 21938532Parvizi J, Zmistowski B, Berbari EF, Bauer TW, Springer BD, Della Valle CJ, Garvin KL, Mont MA, Wongworawat MD, Zalavras CG. New definition for periprosthetic joint infection: from the Workgroup of the Musculoskeletal Infection Society. Clin Orthop Relat Res. 2011 Nov;469(11):2992-4. doi: 10.1007/s11999-011-2102-9. No abstract available.
- Background: PubMed 21866421Mortazavi SM, Vegari D, Ho A, Zmistowski B, Parvizi J. Two-stage exchange arthroplasty for infected total knee arthroplasty: predictors of failure. Clin Orthop Relat Res. 2011 Nov;469(11):3049-54. doi: 10.1007/s11999-011-2030-8.
- Background: PubMed 21553171Koyonos L, Zmistowski B, Della Valle CJ, Parvizi J. Infection control rate of irrigation and debridement for periprosthetic joint infection. Clin Orthop Relat Res. 2011 Nov;469(11):3043-8. doi: 10.1007/s11999-011-1910-2.
- Background: PubMed 20544317Gardner J, Gioe TJ, Tatman P. Can this prosthesis be saved?: implant salvage attempts in infected primary TKA. Clin Orthop Relat Res. 2011 Apr;469(4):970-6. doi: 10.1007/s11999-010-1417-2.
- Background: PubMed 20224958Estes CS, Beauchamp CP, Clarke HD, Spangehl MJ. A two-stage retention debridement protocol for acute periprosthetic joint infections. Clin Orthop Relat Res. 2010 Aug;468(8):2029-38. doi: 10.1007/s11999-010-1293-9.
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Michael P Muldoon, MD principal investigator
Sharp HealthCare
David R Lionberger, MD principal investigator
Southwest Orthopedic Group, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Michael Muldoon, M.D. at 1 site in United States.
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Retention of components (time frame: 12 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 NCT02107924, which also lists 5 linked publications.
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 26 Nov 2014.