Clinical trial NCT02107924: Use of Antibiotic Carrier in Acute Periprosthetic Infections (APPI) of Total Knee Replacements
Official title: Use of Antibiotic Contained Calcium Sulfate Carrier in Acute Periprosthetic Infections(APPI) of Total Knee Replacements
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infection
Keywords: Total
Knee
Replacment
Infection
Stimulan
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: The Methodist Hospital Research Institute
First posted: 2014-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Retention of components
timeFrame: 12 months
measure: Eradication of infection
timeFrame: 12 months
Secondary outcomes:
measure: C-Reactive protein (CRP)
timeFrame: 12 months
measure: Wound complications
timeFrame: 12 months
measure: Knee Society Score
timeFrame: 12 months
measure: Visual Analog Scale
timeFrame: 12 months
measure: Outcome Assessment Scores
timeFrame: 12 months
measure: Ongoing use of antibiotics
timeFrame: 6 weeks
measure: AP and lateral Radiographs of involved joint
timeFrame: 12 months
measure: Positive synovial fluid cell count
timeFrame: pre-operative
measure: Sedimentation Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Southwest Orthopedic Group, LLP
state: Texas
Study officials:
affiliation: Sharp HealthCare
name: Michael P Muldoon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Orthopedic Group, LLC
name: David R Lionberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.