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Cementless One-stage Revision of the Chronic Infected Hip Arthroplasty (CORIHA)

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University of Aarhus

Status

Completed

Conditions

Infection
Hip Joint Replacement

Treatments

Procedure: Cementless one-stage surgical revision

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

56 participants in 1 patient group

Surgical revision
Other group
Description:
Surgical cementless One-stage revision of the chronic infected hip arthroplasty
Treatment:
Procedure: Cementless one-stage surgical revision

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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