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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02107924
• Other study ID #: 1112-0211
• Status: Withdrawn
• Phase: N/A
• First received: April 4, 2014
• Last updated: November 24, 2014
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

Procedure:
• APPI of TKR-Stimulan

Locations

Country	Name	City	State
United States	Southwest Orthopedic Group, LLP	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Michael Muldoon, M.D.	The Methodist Hospital System

Country where clinical trial is conducted

United States, 

References & Publications (5)

Estes CS, Beauchamp CP, Clarke HD, Spangehl MJ. A two-stage retention débridement protocol for acute periprosthetic joint infections. Clin Orthop Relat Res. 2010 Aug;468(8):2029-38. doi: 10.1007/s11999-010-1293-9. — View 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. — View Citation

Koyonos L, Zmistowski B, Della Valle CJ, Parvizi J. Infection control rate of irrigation and débridement for periprosthetic joint infection. Clin Orthop Relat Res. 2011 Nov;469(11):3043-8. doi: 10.1007/s11999-011-1910-2. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of components		12 months	No
Primary	Eradication of infection		12 months	No
Secondary	C-Reactive protein (CRP)		12 months	No
Secondary	Wound complications		12 months	No
Secondary	Knee Society Score		12 months	No
Secondary	Visual Analog Scale		12 months	No
Secondary	Outcome Assessment Scores		12 months	No
Secondary	Ongoing use of antibiotics		6 weeks	No
Secondary	AP and lateral Radiographs of involved joint		12 months	No
Secondary	Positive synovial fluid cell count		pre-operative	No
Secondary	Sedimentation Rate		12 months	No