NCT04262908

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 10, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

5.4 years

First QC Date

February 6, 2020

Last Update Submit

March 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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

Study Arms (1)

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

Interventions

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

Patients implanted with hip or knee prostheses

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Diaconesses Croix saint Simon

Paris, 75020, France

RECRUITING

Related Publications (2)

  • Tilbury C, Schaasberg W, Plevier JW, Fiocco M, Nelissen RG, Vliet Vlieland TP. Return to work after total hip and knee arthroplasty: a systematic review. Rheumatology (Oxford). 2014 Mar;53(3):512-25. doi: 10.1093/rheumatology/ket389. Epub 2013 Nov 23.

    PMID: 24273048BACKGROUND
  • Tilbury C, Leichtenberg CS, Tordoir RL, Holtslag MJ, Verdegaal SH, Kroon HM, Nelissen RG, Vliet Vlieland TP. Return to work after total hip and knee arthroplasty: results from a clinical study. Rheumatol Int. 2015 Dec;35(12):2059-67. doi: 10.1007/s00296-015-3311-4. Epub 2015 Jun 29.

    PMID: 26119221BACKGROUND

Study Officials

  • Wilfrid GRAFF, MD

    Groupe Hospitalier Diaconesses Croix Saint-Simon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilfrid GRAFF, MD

CONTACT

Younes KERROUMI, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic surgeon

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

February 10, 2020

Primary Completion

June 30, 2025

Study Completion

September 30, 2025

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations