Contribution of a Clinical Pathway for the Treatment of Hip Prosthesis Infections

NCT02660268 | Completed

• 1 other identifier: 38RC14.455
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 7

Brief Summary

The main objective is to determine the contribution of a clinical pathway to improve the effectiveness of medico-surgical management of hip prosthesis infections in terms of clinical cure. The hypothesis raised is that the implementation of a clinical pathway would improve the performance of the medical and surgical management of chronic infections of prosthetic hip.

Conditions

Hip Prosthesis Infection

Keywords

Clinical pathway; Infection; Hip; Prosthesis

Outcome Measures

Primary Outcomes (1)

• Clinical cure at 1 year of initial medical management, defined by the absence of the clinical signs of infection, the inflammatory syndrome (C- Reactive Protein <10 mg / L) and the radiological signs of infection

  Clinical cure

  12 months

Secondary Outcomes (8)

• Time duration between first clinical signs and diagnosis

  12 months

• Time duration between diagnosis and therapeutic management

  12 months

• Total duration of antibiotic therapy

  12 months

• Conservation or removal of hip prosthesis

  12 months

• Cumulative length of hospital stay

  12 months

Study Arms (2)

Clinical pathway

EXPERIMENTAL

Patients in the experimental group will be followed according to the clinical pathway

Other: Clinical Pathway

Control

NO INTERVENTION

Patients in the control group will receive standard care

Interventions

Clinical Pathway OTHER

Implementation of a Clinical Pathway for Medical and Surgical Management of Hip Prosthesis Infections

Clinical pathway

Eligibility Criteria

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

You may qualify if:

• Subject ≥ 18 years of age. Having a first episode of hip prosthesis infection defined by an infectious disease physician on clinical , radiological and microbiological criteria according the clinical practice guidelines of the French-Language Infectious Diseases Society May 13, 2009
• Signed Informed Consent
• Supported in one of the participating center (hospitals of Arc Alpin)
• Covered by health insurance

You may not qualify if:

• Subject \< 18 years of age
• Inability to read and understand the participant's Information
• Pregnant women

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (7)

Annecy Hospital

Annecy, 74000, France

Location

Chambéry Hospital

Chambéry, 73000, France

Location

University Hospital of Grenoble

Grenoble, 38700, France

Location

Groupe Hospitalier Mutualiste de Grenoble.

Grenoble, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Hôpital Nord-CHU Saint Etienne

Saint-Etienne, France

Location

Voiron Hospital

Voiron, 38500, France

Location

MeSH Terms

Conditions

Infections

Interventions

Critical Pathways

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Patricia PAVESE, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 21, 2016
• Study Start: March 21, 2016
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

FR (7)