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

Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04262908
Collaborator
(none)
300
1
40.6
7.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Telephone call

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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Socio-professional Categories and Return to Work After Hip or Knee Replacement Surgery
Actual Study Start Date :
Feb 10, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm 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

Other: Telephone call
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

Outcome Measures

Primary Outcome Measures

  1. Identification of socio-professional categories according to the PCS-ESE 2017 classification which would influence the return to work. [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe Hospitalier Diaconesses Croix saint Simon Paris France 75020

Sponsors and Collaborators

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wilfrid GRAFF, Orthopedic surgeon, Groupe Hospitalier Diaconesses Croix Saint-Simon
ClinicalTrials.gov Identifier:
NCT04262908
Other Study ID Numbers:
  • ID RCB : 2019-A00046-51
First Posted:
Feb 10, 2020
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2022