Clinical Trials Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Feb 18, 2021; 12(2): 69-81
Published online Feb 18, 2021. doi: 10.5312/wjo.v12.i2.69
Evaluation of joint awareness after acetabular fracture: Validation of the Forgotten Joint Score according to the COSMIN checklist protocol
Viola Freigang, Johannes Weber, Karolina Mueller, Christian Pfeifer, Michael Worlicek, Volker Alt, Florian Michael Baumann
Viola Freigang, Johannes Weber, Christian Pfeifer, Michael Worlicek, Volker Alt, Florian Michael Baumann, Department of Trauma Surgery, Regensburg University Medical Center, Regensburg 93042, Germany
Karolina Mueller, Center for Clinical Studies, Regensburg University Medical Center, Regensburg 93042, Germany
Author contributions: Freigang V carried out data interpretation, performed literature research and drafted the manuscript; Weber J, Mueller K, Alt V, Pfeifer C and Worlicek M were involved in conduction of the study and significantly participated in preparation of the manuscript; Baumann FM was involved in the design, coordination, and draft of the manuscript; all authors read and approved the final version of the manuscript.
Institutional review board statement: This study was carried out in accordance with the Declaration of Helsinki and approved by the ethics committee at the University of Regensburg in December 2015 (Institutional Review Board Number 15-101-0241). We obtained written informed consent from all study participants.
Clinical trial registration statement: Center for Clinical Studies Registry at University of Regensburg. Registered 01 October 2014, Trial registration number: Z-2014-0389-10.
Informed consent statement: We obtained consent for publication from all study participants.
Conflict-of-interest statement: The authors declare that there is no conflict of interest.
Data sharing statement: The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Florian Michael Baumann, MD, Associate Professor, Surgeon, Department of Trauma Surgery, Regensburg University Medical Center, Franz-Josef-Strauß-Allee 11, Regensburg 93042, Germany. florian.baumann@ukr.de
Received: September 16, 2020
Peer-review started: September 16, 2020
First decision: December 1, 2020
Revised: December 14, 2020
Accepted: January 21, 2021
Article in press: January 21, 2021
Published online: February 18, 2021
Abstract
BACKGROUND

A fracture of the acetabulum is an uncommon, but serious injury. Established outcome tools do not reflect the patient’s perspective after fracture of the hip joint. Originally designed for post-arthroplasty patients, the Forgotten Joint Score (FJS) is a patient-reported outcome measurement (PROM) tool evaluating the disease-specific health-related quality of life (HR-QoL).

AIM

To validate the FJS in patients after acetabular fracture.

METHODS

In a prospective mono-centric cohort study, we evaluated 100 patients at mean 5.2 ± 3.6 years after a fracture of the acetabulum. The validation study followed the complete COSMIN checklist protocol. For calculation of convergent validity, we used the Tegner-Activity Scale, the Western Ontario and McMaster Universities Osteoarthritis Index, the EuroQol-5D, and a subjective rating of change as an anchor variable.

RESULTS

We confirmed good internal consistency with a Cronbach‘s alpha of 0.95. With an intraclass correlation coefficient of 0.99 (95%CI: 0.97, 0.99), test-retest reliability of the FJS was excellent. Correlation coefficients between the questionnaires were moderate to high ranging from |0.56| to |0.83| (absolute value). No relevant floor or ceiling effects occurred. Standard error of measurement was 3.2 and smallest detectable change (SDC) was 8.8. Thus, changes greater than 8.8 points between two assessments denote a real change in FJS.

CONCLUSION

The FJS is a valid and reliable tool for evaluation of patient-reported outcome in posttraumatic condition after acetabular fracture. The SDC indicating a real clinical improvement was 8.8 points in the FJS. We could confirm responsiveness of the FJS and found no relevant floor- or ceiling effects.

Keywords: Patient reported outcome measurement, Validation study, Hip joint, Forgotten Joint Score, Acetabulum fracture, COSMIN checklist

Core Tip: A fracture of the acetabulum is a rare but serious medical condition. Patient-reported outcome measurement has rising impact on clinical decision-making and is of extraordinary value in research. Validation of measurement tools is an essential scientific contribution for further research. This study evaluates psychometric properties of the Forgotten Joint Score in posttraumatic condition after acetabular fractures.