Cementless One-stage Revision of the Chronic Infected Hip Arthroplasty

Not Applicable

Completed

• Conditions: Infection; Hip Joint Replacement
• Interventions: Procedure: Cementless one-stage surgical revision

• Registration Number: NCT01015365
• Lead Sponsor: University of Aarhus

Brief Summary

The investigators hypothesise that cementless one-stage exchange revision surgery can be performed in patients with chronically infected hip replacement with substantial benefits for the patients, in terms of fast rehabilitation, low re-revision rates and good long term results.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Primary Completion: 2016-10
• Status Verified: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patient with clinical signs of infection for more than 4 weeks, arising from total hip arthroplasty (primary and revision), resurfacing hip arthroplasty or hemi-hip arthroplasty
• Informed oral and written consent given

Exclusion Criteria

• Life expectancy under 2 years
• Cognitive dysfunction
• Pre-operative unwillingness to receive blood
• Intravenous drug abuse
• Alcoholism
• Immunocompromised patients
• Patients receiving immunosuppressive medication
• Ongoing systemic inflammatory disease
• Poorly regulated diabetes mellitus
• Renal failure (requiring dialysis)
• Acute systemic inflammatory response syndrome with proven infection (sepsis)
• Signs of coexisting active long-term local infection (i.e. endocarditis)
• Previous two-stage revision of hip arthroplasty due to ipsilateral chronic infection (regardless of symptom free interval) or contralateral chronic infection (within the last 2 years).
• < 6 weeks since last surgery of the affected hip
• If definition of infection is not fulfilled: infection defined as Culture positive: ≥ 3 positive intraoperative cultures (tissue biopsies a.m. Kamme-Lindberg) Culture negative: < 3 positive intraoperative cultures (tissue biopsies a.m. Kamme-Lindberg) + Chronic fistula with history of previous or existing secretion or Positive cultures in pre-operatively joint fluid aspiration with other clinical signs of infection or Visual pus or purulent fluid during exchange procedure with clinical signs of infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical revision	Cementless one-stage surgical revision	Surgical cementless One-stage revision of the chronic infected hip arthroplasty

Primary Outcome Measures

Name	Time	Method
re-infection	2 years

Secondary Outcome Measures

Name	Time	Method
Revision for other cause than infection	2 years

Trial Locations

Locations (8)

Orthopaedic Center, Alborg sygehus, Aarhus Universityhospital; 🇩🇰 Aalborg, Denmark

Orthopaedic department, Aarhus Universityhospital; 🇩🇰 Aarhus, Denmark

Regionalhospital Silkeborg; 🇩🇰 Silkeborg, Denmark

Gentofte Hospital; 🇩🇰 Hellerup, Denmark

Orthopaedic department, Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark

Sønderborg Hospital; 🇩🇰 Sønderborg, Denmark

Regional Hospital Viborg; 🇩🇰 Viborg, Denmark