Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy

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.

Conditions

• Rotator Cuff Arthropathy

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 about glenohumeral osteoarthritis, the role of exercise and exercise related pain, will be sent to all patients in the exercise-group. The physiotherapists delivering the exercise intervention are not otherwise related to the trial.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Regionshospitalet Silkeborg

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• The Danish Rheumatism Association

  collaborator OTHER

• Association of Danish Physiotherapists

  collaborator OTHER

• Regionshospitalet Viborg, Skive

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Tartu University Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Josefine B. Larsen, MSc · Aarhus University Hospital and Aarhus University

• Inger Mechlenburg, Prof. · Aarhus University Hospital and Aarhus University

• Theis M. Thillemann, PhD, As Prof · Aarhus University Hospital and Aarhus University

• Antti P. Launonen, PhD, As Prof · Tampere University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-28

Primary Completion

2028-11-30

Completion

2038-11-30

Countries

• Denmark
• Estonia
• Finland
• Norway

Study Locations