KCE-181158: Durchführbarkeit der Durchführung einer pragmatischen, randomisierten Studie zum Vergleich von sofortiger und verzögerter elektiver Chirurgie zur Behandlung akuter vorderer Kreuzbandverletzungen - IODA-Studie

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

Trial Description
Title

Feasibility of conducting a pragmatic, randomized trial that compares Immediate versus Optional Delayed surgical repair for treatment of acute anterior cruciate ligament injury

Participants (P)

Patients presenting to the clinic with an acute anterior cruciate ligament (ACL) injury

Intervention (I)

Rehabilitation and optional delayed ACL reconstruction.

Control (C)

Immediate ACL reconstruction and rehabilitation

Outcome (O)

Number of patients included (to explore the feasibility to recruit ACL deficient patients for a future randomized controlled trial )

Trial Design

A parallel, multicentric, pragmatic, pilot randomised controlled trial comparing immediate ACL reconstructive surgery (control group) with optional delayed surgery (intervention group).

Sample Size

 58

Trial duration

10 months

Budget

€290 000

Status

Open

 

Trial team

Sponsor

UZ Leuven

Chief Investigator

Prof Dr Koen Peers

Participating Investigators

CHU Liège: Prof. Jean-Francois Kaux (Dept. of Physical Medicine and Rehabilitation)

Documents
Protocol  
Report

Q3/2021

Publication

 

References

Clinicaltrials.gov: NCT04408690

 

Funding scheme

2018 Investigator led