Active — Not RecruitingNot Applicable

Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis

Denmark102 participantsStarted 2021-06-02

Plain-language 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.

Who can participate

Age range55 Years – 85 Years

SexALL

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Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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

What they're measuring

the Western Ontario Osteoarthritis of the Shoulder index (WOOS)

Timeframe: Measured at 12-month follow-up

Trial details

NCT IDNCT04845074

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-25