NCT02107924

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

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, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

April 4, 2014

Last Update Submit

November 24, 2014

Conditions

Infection

Keywords

TotalKneeReplacmentInfectionStimulan

Outcome Measures

Primary Outcomes (2)

  • Retention of components

    12 months

  • Eradication of infection

    12 months

Secondary Outcomes (9)

  • C-Reactive protein (CRP)

    12 months

  • Wound complications

    12 months

  • Knee Society Score

    12 months

  • Visual Analog Scale

    12 months

  • Outcome Assessment Scores

    12 months

  • +4 more secondary outcomes

Study Arms (2)

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

APPI of TKR-StimulanPROCEDURE
Also known as: Stimulan, Tobramycin, Vancomycin
APPI of TKR-Stimulan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Orthopedic Group, LLP

Houston, Texas, 77030, United States

Location

Related Publications (5)

  • 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.

    PMID: 21938532BACKGROUND

  • 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.

    PMID: 21866421BACKGROUND

  • 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.

    PMID: 21553171BACKGROUND

  • 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.

    PMID: 20544317BACKGROUND

  • 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.

    PMID: 20224958BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

StimulanTobramycinVancomycin

Intervention Hierarchy (Ancestors)

NebramycinKanamycinAminoglycosidesGlycosidesCarbohydratesGlycopeptidesGlycoconjugatesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Michael P Muldoon, MD

    Sharp HealthCare

    PRINCIPAL INVESTIGATOR

  • David R Lionberger, MD

    Southwest Orthopedic Group, LLC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Sponsor

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 8, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations

US(1)