Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis

NCT04845074 | Active Not Recruiting DMC

• 1 other identifier: PROACT
• Study Type: interventional
• Target: 102
• Locations: 3 countries
• Sites: 7

Brief Summary

Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. However, the effectiveness of TSA 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 TSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with primary glenohumeral OA eligible for unilateral TSA. We hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (18-point, on a scale from 0-100) improvement compared to the exercise intervention.

Conditions

Glenohumeral Osteoarthritis

Keywords

Physiotherapist-supervised Exercise; Physical Therapy; Physical Rehabilitation; Anatomical total shoulder arthroplasty; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• the Western Ontario Osteoarthritis of the Shoulder index (WOOS)

  WOOS consist of 19 items to be answered using a visual analog scale (VAS). Each item has a possible score ranging from 0 to 100, leading to a total WOOS score ranging from 0 to 1900, with 0 being the best. For simplicity reasons, raw scores can be converted to a percentage of the maximum score (0-100, 100 best).

  Measured at 12-month follow-up

Secondary Outcomes (6)

• the Western Ontario Osteoarthritis of the Shoulder index (WOOS)

  Measured at baseline, 12-week, 2-, 5- and 10-year follow-up

• Disabilities of the Arm, Shoulder and Hand (DASH)

  Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up

• The 100 mm Visual Analogue Scale.

  Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up

• The use of analgesics during the last week

  Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up

• Serious Adverse Events

  The patients in the surgical intervention group will be monitored for serious adverse events during the 4 weeks from the discharge.

Other Outcomes (10)

• Accelerometer-based activity using tri-axial (Axivity, UK) accelerometers

  Measured at baseline and 12-month follow-up

• The 100 mm Visual Analogue Scale.

  Measured immediately before and after each exercise session

• EQ-5D-5L

  Measured at baseline, 12-week, 12-month, 2-, 5- and 10-year follow-up.

Study Arms (2)

TSA-group

EXPERIMENTAL

Surgery

Procedure: TSA-group

Exercise-group

EXPERIMENTAL

Exercise

Other: Exercise-group

Interventions

TSA-group PROCEDURE

Anatomical total shoulder arthroplasty followed by standard rehabilitation.

TSA-group

Exercise-group OTHER

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.

Exercise-group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥55-85 years
• Moderate-severe primary OA of the glenohumeral joint according to Samilson and Prieto, by measuring the lower osteophyte (32)
• Eligible for surgery with standard TSA

You may not qualify if:

• Surgical need for bonegraft
• 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)
• Unable to communicate in the participating countries respective languages

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Tampere University Hospital: collaborator
• Regionshospitalet Viborg, Skive: collaborator
• Aalborg University Hospital: collaborator
• Regionshospitalet Silkeborg: collaborator
• Oslo University Hospital: collaborator
• The Danish Rheumatism Association: collaborator
• Association of Danish Physiotherapists: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator

Study Sites (7)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Esbjerg Hospital

Esbjerg, 6700, Denmark

Location

Aalborg University Hospital

Farsø, 9640, Denmark

Location

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Viborg Regional Hospital

Viborg, 8800, Denmark

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Oslo University Hospital

Oslo, 4956, Norway

Location

Related Publications (1)

• Beck Larsen J, Thillemann TM, Launonen AP, Ostergaard HK, Falstie-Jensen T, Reito A, Lund Jensen S, Mechlenburg I. Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis - a multicenter, randomized controlled trial. Acta Orthop. 2022 Feb 8;93:303-316. doi: 10.2340/17453674.2022.2043.

  PMID: 35138410 DERIVED

Study Officials

• Josefine B. Larsen, MSc

  Aarhus University Hospital and Aarhus University

  PRINCIPAL INVESTIGATOR

• Inger Mechlenburg, Prof.

  Aarhus University Hospital and Aarhus University

  STUDY DIRECTOR

• Theis M. Thillemann, PhD, As Prof

  Aarhus University Hospital and Aarhus University

  STUDY DIRECTOR

• Antti P. Launonen, PhD, As Prof

  Tampere University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 14, 2021
• Study Start: June 2, 2021
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 25, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available after publication of the trial.
• Access Criteria: Data access will be reviewed by the author group. Requestors will be required to sign a Data Access Agreement.

Locations

DK (5); FI (1); NO (1)