Hip Arthropathy Associated With Other ConditionsARRET-ProNCT04262908
Socio-professional Categories and Return to Work After Hip or Knee Replacement Surgery
An observational study of Hip Arthropathy Associated With Other Conditions, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hip Arthropathy Associated With Other Conditions
- What is being tested?
- Telephone call
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2020to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Proven depression or patient under antidepressant treatment
- Bipolarity, psychosis and neuroleptic treatment
- Retired patient
- Patient on sick leave ≥ 1 month before the intervention
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Diaconesses Croix saint Simon
Paris, 75020
Wilfrid GRAFF, MD, wgraff@hopital-dcss.org
About this study
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.
Read the 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.
- Being tested
- Telephone call
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone callOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Telephone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through study completion, an average of 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start10 Feb 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip Arthropathy Associated With Other ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilfrid GRAFF, Groupe Hospitalier Diaconesses Croix Saint-Simon
- Investigators
- Wilfrid GRAFF, MD, Principal investigator, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262908
- Sponsor's protocol ID
- ID RCB : 2019-A00046-51
- Acronym
- ARRET-Pro
- Status last verified
- Mar 2023
- First submitted
- 6 Feb 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24273048Tilbury 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.
PubMed 26119221
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socio-professional Categories and Return to Work After Hip or Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT04262908
- Acronym / sponsor ID
- ARRET-Pro / ID RCB : 2019-A00046-51
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with hip or knee prostheses | – | Other: Telephone callPatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone callPatients 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 | Other | Patients implanted with hip or knee prostheses |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 24273048Tilbury 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.
- Background: PubMed 26119221Tilbury 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfrid GRAFF, MD principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthropathy Associated With Other Conditions, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilfrid GRAFF, MD (003344641640, wgraff@hopital-dcss.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262908, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.