None (observational registry for future research)
ID
Bron
Verkorte titel
Aandoening
Fracture Related Infection (FRI)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
None (observational registry for future research)
Achtergrond van het onderzoek
Rationale
Fracture-related infections (FRIs) are a major medical and socioeconomic problem. Decision on the optimal surgical treatment of FRI remains a challenge. Knowledge on the outcomes and costs of diagnosing and treatment of this condition should be optimized to aid decision making processes and patient counselling.
Objective
To collect specific data, in order to create a registry that can be used for future research, such as, on improving general knowledge, optimising diagnosing and treatment strategies, identify factors associated with outcomes, cost- effectiveness and improving patient satisfaction of patients suffering from an FRI.
Study design
This is a longitudinal observational registry. Study population: All patients above 15 years of age undergoing treatment (operative or non-operative) for suspected or established FRI in participating centres.
Main study parameters/endpoints
Data will be collected for future research for which the purpose is not known at this time. All participants fill out 4 questionnaires (EuroQol 5D (EQ-5D), Short Musculoskeletal Function Assessment (SMFA), Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ). When new research will be conducted, study parameters will be set. A study application will than be submitted to the METC with an outline of specific study parameters and endpoints.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness
The burden for patients to participate in this study is minimal and consists of time. Any future results may be beneficial for patients. Participation or refusal to participate in the study will not have consequences for their treatment.
Doel van het onderzoek
None (observational registry for future research)
Onderzoeksopzet
0,3,6,9,12,and 24 months
Onderzoeksproduct en/of interventie
None (observational registry for future research)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to be included in the DFIR, a subject must be >15 years and undergoing investigation and/or treatment (operative or non-operative) and/or follow-up for a proven or suspected FRI in one of the participating centres. FRI or suspected FRI is defined according to the FRI consensus definition (REF: Metsemaker et al, Injury 2018). This definition consists of definite signs (FRI present) and suggestive signs (FRI suspected). Both types of signs qualify for inclusion,and both early (onset < 6 weeks after initial fracture operation) and late (onset > 6 weeks after fracture operation) can be included.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Fracture patients with an unremarkable postoperative course
• Age < 16 years
• Expected inability to meet at least 1 year follow-up
• No Dutch or English proficiency
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8647 |
| Ander register | METC - UMCU : METC-protocol number 20-391/C |