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

Overview

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.

Interventions

• Procedure TSA-group
  Reverse total shoulder arthroplasty followed by standard rehabilitation.
• Other Exercise-group
  The exercise-group will attend a 12-week exercise program with one weekly physiotherapist-supervised session supplemented with two weekly sessions of home-based exercises. Utilisation of a predefined training protocol describing procedures and content of each session secure uniformity and standardisation of the intervention. The exercise program consists of two warm-up exercises and five exercises that target shoulder range of motion and muscle strength. Furthermore, a link to a video, informing

Primary outcome measures

• the Western Ontario Osteoarthritis of the Shoulder index (WOOS) [Time frame: Measured at 12 month follow-up]

Secondary outcome measures (8)

• the Western Ontario Osteoarthritis of the Shoulder index (WOOS) [Time frame: Measured at baseline, 12-week, 2-, 5- and 10-year follow-up]
• Disabilities of the Arm, Shoulder and Hand (DASH) [Time frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up]
• The change in pain measured on a 100 mm Visual Analogue Scale (VAS) [Time frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up]
• The use of analgesics during the last week [Time frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up]
• The type of analgesics consumed during the last week [Time frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up]
• Consumption of analgesics during the last week [Time frame: Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up]
• Serious Adverse Events [Time frame: The patients in the surgical intervention group will be monitored for serious adverse events during the 4 weeks from the discharge.]
• Adverse events [Time frame: Occurring during the period from inclusion until the 12-month follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Denmark · 5 centers

• Aarhus University Hospital — Aarhus N
• Esbjerg Hospital — Esbjerg
• Aalborg University Hospital — Farsø
• Silkeborg Regional Hospital — Silkeborg
• Viborg Regional Hospital — Viborg

Estonia · 1 center

• Tartu University Hospital — Tartu

Finland · 1 center

• Tampere University Hospital — Tampere

Norway · 1 center

• Oslo University Hospital — Oslo

Publications

• Larsen JB, Thillemann TM, Launonen AP, Ostergaard HK, Falstie-Jensen T, Reito A, Jensen SL, Mechlenburg I. Prosthesis versus exercise for rotator cuff tear arthropathy - protocol of a randomised controlled trial. Dan Med J. 2025 Aug 22;72(9):A09240645. doi: 10.61409/A09240645. PMID 40927835

Identifiers

NCT: NCT04864158 · REACT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗