Socio-professional Categories and Return to Work After Hip or Knee Replacement Surgery (ARRET-Pro)

March 22, 2023 updated by: Wilfrid GRAFF, Groupe Hospitalier Diaconesses Croix Saint-Simon

A significant proportion of patients (15 to 45%) who have benefited from a total hip or knee replacement surgery (THKA), are put on sick leave (SL). This SL allows these patients who had a professional activity at the time of the intervention (age <65 years) to enhance the healing, improve the quality of life and ensure a functional return to work. The number of patients returning to work and the time taken to return to work after the intervention are d depending on the intervention (hip or knee) and are linked to socio-demographic factors, to the patient's general condition (comorbidity, presence of other arthritis joints…) and the type of professional activity.

Studies evaluating the impact of the type of professional activity on the return to work after THKA are nonexistent in France, rare in the literature, mostly retrospective and methodologically weak. In addition, the individual and socioeconomic impact of the cessation of work after an THKA, the absence of national data assessing the predictive nature of socio-professional categories on the return to work using a multivariate analysis motivated us to set up this study.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

The data usually collected in the medical file will be collected as part of the preoperative and 3 months postoperative study. As part of this study, a phone call will be made to contact patients who have had a prolonged SL

The data collected are as follows:

During hospitalization Socio-demographic data: sex, age, title of the profession, the joint concerned, family situation, place of life, postoperative availability of a caregiver or home help if necessary.

Clinical data: Comorbidities, weight, height, date of the arthroplasty, per and or postoperative complications of the arthroplasty, date of prescribed work stoppage

3 months postoperative: medical consultation Date of the 3-month consultation, date and method of resumption of work, if applicable, otherwise the duration of the extension of the duration of the SL, the doctor prescribing the extension and the causal link of this extension to the arthroplasty

4 months postoperative: telephone call This phone call will relate to patients whose work stoppage has been extended. Will be collected, the date and the mode of resumption of work, if not the cause of not resumed.

For patients whose prolongation of SL has been prescribed by the attending physician, the doctor of the rehabilitation center (knee prostheses) or by the occupational physician, the latter will be contacted by telephone to collect the reason for prolongation of the TA.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Paris, France, 75020
        • Recruiting
        • Groupe Hospitalier Diaconesses Croix Saint Simon
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients consulting our orthopedic surgery department for a first total hip or knee arthroplasty who meet the study selection criteria The total number of inclusions is estimated at 300 patients.

Description

Inclusion Criteria:

  • Information of the patient and obtaining his non-opposition
  • Men and women aged ≥ 18 and ≤ 65 and in full-time or part-time paid or voluntary professional activity before the intervention or before the work stoppage justified by the planned arthroplasty
  • Patients consulting our orthopedic surgery department for the first implantation of a hip or knee prosthesis following arthritis

Exclusion Criteria:

  • The patient expresses his opposition to the use of his personal data
  • Patient> 65 years' old
  • Arthroplasty on septic arthritis
  • Presence of another hip or knee prosthesis already implanted
  • Radiological stage 4 of osteoarthritis of the knee or hip not operated
  • ASA > 3
  • Proven depression or patient under antidepressant treatment
  • Bipolarity, psychosis and neuroleptic treatment
  • Retired patient
  • Patient on sick leave ≥ 1 month before the intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients implanted with hip or knee prostheses
Patients who had hip or knee arthroplasty will be followed and asked at 3-months visit if they resumed their job or not. In both cases, further informations will be gathered
Patients who did not return to work after the SL prescribed initially and had an extension of the SL will be called at 4 months postoperatively to collect infomation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of socio-professional categories according to the PCS-ESE 2017 classification which would influence the return to work.
Time Frame: Through study completion, an average of 21 months

To respond to the main objective of the study, investigator will collect

○ socio-demographic data during the anamnesis (sex, profession, joint concerned (hip, knee), family situation, place of life, presence of caregiver, co-morbidities, presence of other joint prostheses.

  • Clinical data (weight, height, musculoskeletal examination for other arthritis joints)
  • Data during hospitalization (date of surgery, intraoperative or postoperative complications (dislocation of prosthesis, bone or prosthesis stem fracture, hematoma, prosthesis infection)
  • Data concerning the work stoppage at 3 months during the usual follow-up consultation and by telephone as part of the study intervention about patients who have had a work stoppage extension (date of stoppage of work, date of resumption of work and mode of resumption, duration of extension of the SL, etc)
Through study completion, an average of 21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wilfrid GRAFF, MD, Groupe Hospitalier Diaconesses Croix Saint-Simon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

September 30, 2025

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID RCB : 2019-A00046-51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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