Occupational support for patients undergoing arthroplasty of the lower limb Musculoskeletal Diseases
Conditions
Interventions
The OPAL trial is a two-arm multi-centre, randomised, superiority trial with parallel groups. Patients will be allocated to a) the OPAL support intervention or b) standard care. There will be a 6-mont
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults (>=16 years) listed for elective primary hip or knee replacement in paid or unpaid work who intend to RTW after surgery.
Exclusion criteria
Exclusion criteria: 1. Patients undergoing emergency arthroplasty (e.g. for trauma). 2. Adults listed for elective ankle replacement. 3. Adults planned to undergo further surgery within the 6 months after their joint replacement. Added 07/06/2024: 4. Patients listed for bilateral knee replacements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time until ‘full’ sustained return to any work, defined as work resumption to the same hours as prior to joint replacement, in any role, without any day of sick leave for a consecutive 4-week period. This is measured monthly via questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to any return to work, measured monthly via questionnaire. 2. Measures of functional recovery to daily activities and social participation using the following: 2.1. Oxford hip/knee score (OKS/OHS) - at baseline, 3, 6, 9, and 12 months. 2.2. Lower extremity functional scale (LEFS) - at baseline, 3, 6, 9, and 12 months. 2.3. PROMIS social participation short form questionnaires (social roles and activities questionnaire, satisfaction with participation in social roles questionnaires) - at baseline, 3, 6, 9, and 12 months. 3. Number of ‘sick days’ between surgery and ‘full’ sustained return to work - measured monthly via questionnaire. 4. Participant adherence to the intervention and the intervention’s physical rehabilitation programme - self-reported Likert scales upon achieving the primary outcome. 5. Proportion of participants using workplace interventions, adaptions and modifications to facilitate their RTW measured by questionnaire upon achieving the primary outcome. 6. Health-related quality of life measured via EQ-5D-5L at baseline, 3, 6, 9, and 12 months. 7. Work Productivity measured via Work Limitations Questionnaire at baseline, 3, 6, 9, and 12 months. | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactLesley Sinclair-Smith
Outcome results
None listed