Short Interval in Treatment of PJI

NCT02372435 | Unknown DMC

• 1 other identifier: ChariteU
• Study Type: interventional
• Target: 418
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with hip, knee and shoulder PJI, will be treated with a two-stage exchange Revision. Patients will be randomized into 2 groups: the experimental Group will get a reimplantation after a short interval (2-3 weeks) while the control Group after a long standard interval. Primary objective of the study is "Infection outcome". The infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening). Secondary objective is "Functional outcome".The functional assessment will be performed using joint-specific scores (HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE, OXFORD HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE) involving the range of motion (ROM), patient mobility / independency in daily life, subjective evaluation of pain using a visual analog pain scale (1-10 points) and life-quality evaluation (EQ5D5L score).

Conditions

Hip Prosthetic Joint Infection; Knee Prosthetic Joint Infection; Shoulder Prosthetic Joint Infection

Keywords

PJI

Outcome Measures

Primary Outcomes (1)

• Infection outcome

  Duration of infection-free interval and frequency of adverse events related to surgical treatment. The infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening).

  12 months after surgery

Secondary Outcomes (1)

• Functional outcome

  12 months after surgery

Study Arms (2)

Short interval

EXPERIMENTAL

Re-Implantation of the prosthesis after a short interval of 2-3 weeks after explantation ("fast-track-arm").

Procedure: Shortening of the interval of two-stage prosthesis exchange

Long interval

ACTIVE COMPARATOR

Re-Implantation of the prosthesis after a Long interval of 6-10 weeks (standard surgical treatment).

Procedure: Shortening of the interval of two-stage prosthesis exchange

Interventions

Shortening of the interval of two-stage prosthesis exchange PROCEDURE

The Intervention consist in shortening of the interval between Explantation and re-implantation in patients undergoing a two-stage prosthesis Exchange. Comparison between arms is performed between short and long interval before re-implantation.

Long interval; Short interval

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged ≥18 years with hip, knee or shoulder PJI, in whom all prosthetic components are removed.
• The standard treatment for systemic and local antibiotics is followed (predetermined algorithm).

You may not qualify if:

• Treatment with debridement and prosthesis retention (e.g. performed in early postoperative or acute hematogenous infections with symptom duration \<3 weeks) or one-stage exchange.
• PJI caused by difficult-to-treat organisms, including rifampin-resistant staphylococci, quinolone-resistant Gram-negative bacilli and fungi.
• Subject previously enrolled in this study or is currently enrolled in another competitive investigational study.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Officials

• Andrej Trampuz, PD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antje Spranger

CONTACT

+4930450652416; antje.spranger@charite.de

Alessandra C Bardelli, M.Sc.PH

CONTACT

+4930450552407; alessandra-catalina.bardelli@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Andrej Trampuz

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: February 26, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2018
• Last Updated: February 26, 2015

Record last verified: 2015-02