WithdrawnNCT02107924Updated Nov 26, 2014

Use of Antibiotic Carrier in Acute Periprosthetic Infections (APPI) of Total Knee Replacements

An observational study in Infection, sponsored by Michael Muldoon, M.D.. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-26.

Sponsored by Michael Muldoon, M.D. · Observational

Why this study was withdrawn

No Funding

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 0
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Infection

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Keywords

Total
Knee
Replacment
Infection
Stimulan

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

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Lead sponsor

This is the only study on the registry with Michael Muldoon, M.D. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

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

Inclusion criteria

APPI within 28 days of primary TKR
Acute hematogenous infection within 4 weeks of symptoms

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 0 participants (actual)
Patient registry: No

Groups and cohorts

APPI of TKR-Stimulan
Surgery Stimulan beads 2.4 G Tobramycin 2.0 G Vancomycin
Procedure: APPI of TKR-Stimulan
APPI of TKR-historical
Surgery 2.4 G Tobramycin 2.0 G Vancomycin

Interventions

ProcedureAPPI of TKR-Stimulan
Also known as: Stimulan, Tobramycin, Vancomycin

What researchers measure

Primary outcomes

Retention of components
Time frame: 12 months
Eradication of infection
Time frame: 12 months

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

Study locations

1 site

Southwest Orthopedic Group, LLP
Houston, Texas 77030, United States

References and documents

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 21938532 ↗
Mortazavi 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 21866421 ↗
Koyonos 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 21553171 ↗
Gardner 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 20544317 ↗
Estes 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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02107924
Lead sponsor: Michael Muldoon, M.D.
Collaborators: The Methodist Hospital Research Institute
Responsible party: Michael Muldoon, M.D. (Co-Sponsor, Sharp HealthCare) — Sponsor-investigator
First posted: Apr 8, 2014
Start date: Apr 2014
Primary completion: Dec 2015 (estimated)
Completion: Dec 2015 (estimated)
Last update: Nov 26, 2014

Study contacts

Michael P Muldoon, MD

principal investigator · Sharp HealthCare

David R Lionberger, MD

principal investigator · Southwest Orthopedic Group, LLC

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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