Clinical trial NCT04864158: Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
Official title: Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy Eligible For Reverse Shoulder Arthroplasty: the ReAct Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Arthropathy
Keywords: Physiotherapist-supervised Exercise
Physical Therapy
Physical Rehabilitation
Reverse Shoulder Arthroplasty
Randomized Controlled Trial
Cuff Tear Arthropathy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Tampere University Hospital
name: Aalborg University Hospital
name: Regionshospitalet Silkeborg
name: Oslo University Hospital
name: The Danish Rheumatism Association
name: Association of Danish Physiotherapists
name: Regionshospitalet Viborg, Skive
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Tartu University Hospital
First posted: 2021-04-28
Enrollment: 102
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reverse shoulder arthroplasty (RSA) is a well-established treatment for rotator cuff arthropathy. However, the effectiveness of RSA has not been compared to non-surgical treatment in a randomised controlled trial. Shoulder exercises may be an effective treatment for reducing pain and improving function in glenohumeral osteoarthritis. The primary aim of this trial is to examine if RSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with rotator cuff arthropathy eligible for unilateral RSA. The investigators hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (14-point, on a scale from 0-100) improvement compared to the exercise intervention.

Detailed description: Rotator cuff arthropathy describes the clinical scenario of massive rotator cuff ruptures associated with glenohumeral joint degeneration and superior migration of the humeral head. Clinical presentation includes joint effusion, pain, and loss of mobility. Reverse shoulder arthroplasty (RSA) is a well-established treatment for rotator cuff arthropathy. Several studies have suggested the need for trials comparing shoulder arthroplasty to non-surgical treatments.

The ProAct trial is a Nordic multicenter randomized controlled trial. Patients with rotator cuff arthropathy, eligible for a RSA will be randomised to either RSA followed by usual care or exercise only. The exercise intervention consists of 12 weeks of exercise with one weekly physiotherapist-supervised exercise session.

The primary outcome will be the total the Western Ontario Osteoarthritis of the Shoulder index score at 12 months follow-up. Outcome assessment will be performed at baseline, and at 3 and 12 months and 2-, 5- and 10 years after start of surgical/non-surgical treatment.

Patients fulfilling the eligibility criteria but declining to participate in the randomised trial will be offered the option of participating in an observational cohort using the same primary end point and patient reported outcomes, but following usual clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patients 60-85 years
* Eligible for RSA
* Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33)

Exclusion Criteria:

* Previous shoulder fracture (fracture of the proximal humerus or glenoid fracture)
* Planned other upper extremity surgery within six months
* Rheumatoid arthritis or other types of arthritis not diagnosed as primary glenohumeral OA
* Cancer diagnosis and receiving chemo-, immuno- or radiotherapy
* Neurological diseases affecting shoulder mobility (e.g. disability after previous stroke, multiple sclerosis, Parkinson's, Alzheimer's disease)
* Other reasons for exclusion (i.e. mentally unable to participate) or planned absence for more than 14 days in the first 3 months after baseline test.
* Unable to communicate in the participating countries respective languages

Primary outcomes:
measure: the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
timeFrame: Measured at 12 month follow-up
Secondary outcomes:
measure: the Western Ontario Osteoarthritis of the Shoulder index (WOOS)
timeFrame: Measured at baseline, 12-week, 2-, 5- and 10-year follow-up
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
measure: The change in pain measured on a 100 mm Visual Analogue Scale (VAS)
timeFrame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
measure: The use of analgesics during the last week
timeFrame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
measure: The type of analgesics consumed during the last week
timeFrame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
measure: Consumption of analgesics during the last week
timeFrame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up
measure: Serious Adverse Events
timeFrame: The patients in the surgical intervention group will be monitored for serious adverse events during the 4 weeks from the discharge.
measure: Adverse events
timeFrame: Occurring during the period from inclusion until the 12-month follow-up
Other outcomes:
measure: Accelerometer-based activity using tri-axial (Axivity, UK) accelerometers
timeFrame: Measured at baseline and 12-month follow-up
measure: Accelerometer-based degree of movement using tri-axial (Axivity, UK) accelerometers
timeFrame: Measured at baseline and 12-month follow-up
measure: The 100 mm Visual Analogue Scale (exercise-group)
timeFrame: Measured immediately before and immideately after each exercise session. From the date of the start of the exercise intervention until the end of the exercise intervention, assessed up to 12 months.
measure: EuroQol Group 5-dimension 5-level (EQ-5D-5L)
timeFrame: Measured at baseline, 12-week, 12-month, 2- 5- and 10-year follow-up.
measure: Productivity Costs Questionnaire (iPCQ)
timeFrame: Measured at 12-week and 12-month.
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Measured at 12-month, 2-, 5- and 10-year follow-up.
measure: Treatment Failure
timeFrame: Measured at 12-month, 2-, 5- and 10-year follow-up.
measure: Number of total shoulder arthroplasty surgeries (exercise-group)
timeFrame: Measured from baseline to 12-month, 2-, 5- and 10-year follow-up.
measure: Number of supervised exercise sessions from baseline to 3 months (exercise-group)
timeFrame: From baseline to 12-week
measure: Number of patients performing unsupervised exercise (exercise-group)
timeFrame: From baseline to 12-week
measure: Number of patients performing unsupervised exercise (exercise-group)
timeFrame: From 12-week to 12-month
Locations:
city: Aarhus N, 8200
country: Denmark
facility: Aarhus University Hospital
city: Esbjerg
country: Denmark
facility: Esbjerg Hospital
city: Farsø
country: Denmark
facility: Aalborg University Hospital
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Aarhus University Hospital and Aarhus University
name: Josefine B. Larsen, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital and Aarhus University
name: Inger Mechlenburg, Prof.
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital and Aarhus University
name: Theis M. Thillemann, PhD, As Prof
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital
name: Antti P. Launonen, PhD, As Prof
role: STUDY_DIRECTOR
References: