- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07419217
Professional Impact of Osteoarticular Trauma (IPTO)
Professional Impact of Osteoarticular Trauma: Retrospective Study on Return to Work, Accommodations, and Recognition in the Workplace
This study aims to describe the medical, social, and organizational determinants of returning to work after an osteoarticular injury, particularly limb fractures.
Using observational data, the study will evaluate the modalities of returning to work within 12 months of the injury and analyze the factors influencing professional reintegration, including the severity of the injury, functional recovery, pain, professional characteristics, workplace accommodations, and administrative support measures such as recognition of disabled worker status.
The study will also explore the point at which the issue of returning to work is first raised with the patient during hospitalization, a period during which professional reintegration is often insufficiently anticipated. By identifying current practices and breaking points, this study aims to improve understanding of the pathways to returning to work in the context of the healthcare system and the world of work in France.
Study Overview
Status
Detailed Description
Osteoarticular trauma, particularly limb fractures, is a major public health problem and frequently affects young people of working age. These injuries often result in prolonged interruption of professional activity and significant socioeconomic consequences. Returning to work is a key step in the rehabilitation process after trauma, but it is influenced by a wide range of medical, social, and organizational factors.
Medical determinants include the severity of the injuries, functional limitations, pain, and long-term sequelae. In addition, professional and social factors such as the type of job, employer support, the possibility of workplace accommodations, and administrative procedures related to disability recognition can strongly influence the terms of return to work. Beyond clinical recovery, the organization of care pathways and coordination with occupational health services also play a decisive role in professional reintegration.
This observational study aims to describe the pathways to return to work after osteoarticular trauma in the French context. It will assess the rate of return to work within 12 months of the trauma, as well as the time taken to resume professional activity. It will also analyze the medical, social, and professional factors associated with returning to work, including workplace accommodations and the implementation of administrative measures related to disability.
The study will further explore the point at which the issue of return to work is first raised with patients during hospitalization. This period is a critical phase during which professional reintegration is often insufficiently anticipated. By identifying current practices and the timing of these discussions, the study aims to better characterize existing gaps in the early anticipation of professional return.
By providing descriptive data on the determinants of return to work after osteoarticular trauma, this study aims to improve understanding of professional reintegration pathways and guide the development of future strategies that promote earlier anticipation and enhanced coordination of return to work within healthcare systems and the world of work.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Auriane AS SLAMA
- Phone Number: +33607317969 +33 143967556
- Email: auriane.slama@ght94n.fr
Study Locations
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-
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Saint-Maurice, France, 94410
- Recruiting
- Hôpitaux Paris Est Val-de-Marne - Service de rééducation orthopédique et traumatologie
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Contact:
- Auriane AS SLAMA
- Phone Number: +33607317969 +33 143967556
- Email: auriane.slama@ght94n.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study population consists of adult patients of working age who were employed prior to experiencing an osteoarticular trauma, including fractures of the limbs.
Participants were followed at a tertiary hospital center and received care for osteoarticular trauma between June 2021 and June 2024. The study includes patients with available medical records allowing retrospective data extraction, as well as prospective collection of self-reported data through questionnaires, without any modification of standard clinical care.
Description
Inclusion Criteria:
- Adults who were treated for osteoarticular trauma at the hospital between June 2021 and June 2024
- Patients who were employed prior to the injury
Exclusion Criteria:
- Death or major disability preventing completion of the questionnaire
- Protected persons
- Refusal to participate or no contact after follow-up
- Patients who were unemployed prior to the trauma
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Working-Age Adults With Osteoarticular Trauma
This cohort includes adult patients of working age who were employed prior to an osteoarticular trauma and were followed at a tertiary hospital center. Participants experienced osteoarticular trauma, including limb fractures, between June 2021 and June 2024. Data are collected retrospectively from medical records and prospectively through self-administered questionnaires, without any modification of standard care. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Return-to-work rate within 12 months after osteoarticular trauma
Time Frame: Up to 12 months after trauma
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Assess the professional impact of osteoarticular trauma by measuring the rate of return to work within 12 months of the trauma.
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Up to 12 months after trauma
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to return to work after osteoarticular trauma
Time Frame: From inclusion to return to work (up to 12 months)
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Duration between the date of osteoarticular trauma and the date of return to work, expressed in days
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From inclusion to return to work (up to 12 months)
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Workplace accommodations implemented after trauma
Time Frame: Within 12 months after trauma, as reported at study inclusion
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Implementation of workplace accommodations following osteoarticular trauma, including job adjustments, modified duties, or adapted working conditions
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Within 12 months after trauma, as reported at study inclusion
|
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Recognition of disability status (RQTH)
Time Frame: Within 12 months after trauma, as reported at study inclusion
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Implementation of disability recognition status (Reconnaissance de la Qualité de Travailleur Handicapé, RQTH), a French administrative measure allowing access to workplace accommodations and vocational support.
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Within 12 months after trauma, as reported at study inclusion
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Time to return to work and predictors (hazard ratios)
Time Frame: Up to 12 months after trauma
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Time from inclusion to return to work will be measured in months. Time-to-event analysis will be performed using Kaplan-Meier survival curves. Medical, social, and occupational variables will be evaluated as predictors of time to return to work using Cox proportional hazards regression models. Results will be expressed as hazard ratios (HR) with 95% confidence intervals. |
Up to 12 months after trauma
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Timing of return-to-work discussion during hospitalization
Time Frame: From hospital admission to hospital discharge (up to 30 days).
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Time (in days) from hospital admission to the first discussion regarding return to work with the patient will be recorded during the hospitalization period.
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From hospital admission to hospital discharge (up to 30 days).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Belot BS Sylvain, PH, Hôpitaux Paris Est Val-de-Marne, service de rééducation et réadaptation des affections du système locomoteur adulte,Saint-Maurice 94410
- Study Director: Meriem MA Ait Mamar, MD, Hôpitaux Paris Est Val-de-Marne, service de rééducation et réadaptation des affections du système locomoteur adulte, Saint-Maurice 94410
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IPTO
- 2025-A01974-45 (Other Identifier: Agence national de sécurité du médicament et des produits de santé)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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