NCT01015365

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

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

November 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

6.9 years

First QC Date

November 6, 2009

Last Update Submit

November 17, 2017

Conditions

InfectionHip Joint Replacement

Keywords

Chronic infected hip arthroplastyFast-trackOne-stage cementless revision

Outcome Measures

Primary Outcomes (1)

  • re-infection

    2 years

Secondary Outcomes (1)

  • Revision for other cause than infection

    2 years

Study Arms (1)

Surgical revision

OTHER

Surgical cementless One-stage revision of the chronic infected hip arthroplasty

Procedure: Cementless one-stage surgical revision

Interventions

Cementless one-stage surgical revisionPROCEDURE

A Cementless one-stage surgical revision is to be performed for all included in the cohort.

Surgical revision

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Orthopaedic Center, Alborg sygehus, Aarhus Universityhospital

Aalborg, 9000, Denmark

Location

Orthopaedic department, Aarhus Universityhospital

Aarhus, 8000, Denmark

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Orthopaedic department, Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Regionalhospital Silkeborg

Silkeborg, 8600, Denmark

Location

Sønderborg Hospital

Sønderborg, 6400, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

Regional Hospital Viborg

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Kjeld Soballe, Prof. D.Msc.

    Lundbeckfoundation center for fast-track hip and knee surgery

    STUDY CHAIR

  • Jeppe Lange, M.D.

    Lundbeckfoundation center for fast-track hip and knee surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 18, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2016

Study Completion

November 1, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

DK(8)