CompletedNot Applicable

Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder

Denmark32 participantsStarted 2006-12

Plain-language summary

The purpose of this study is to determine whether there is a difference between the result of treatment of shoulder osteoarthritis with two different shoulder prostheses.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with shoulder osteoarthritis with cartilage defect of the caput humeri and not the glenoid cavity
. Aged 18 years or older and fit
. Informed, written consent -

Exclusion criteria

. Patients found unsuitable preoperatively for a resurfacing prosthesis
. Patients aged 85 or older
. Patients with rheumatoid arthritis
. Patients who previously had undergone shoulder alloplasty or other major shoulder surgery (more than just diagnostic arthroscopy)
. Patients unable to avoid NSAID after surgery
. Patients requiring regular systemic steroid treatment
. Female patients taking hormone substitution
. Patients with metabolic bone disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Migration of resurfacing prostheses

Timeframe: five years

Bone density around the prosthesis

Timeframe: five years

Pain

Timeframe: five years

Activities of Daily Living (ADL)

Timeframe: five years

Trial details

NCT IDNCT00408096

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03

View on ClinicalTrials.gov More Osteoarthritis trials

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with shoulder osteoarthritis with cartilage defect of the caput humeri and not the glenoid cavity
. Aged 18 years or older and fit
. Informed, written consent -

Exclusion criteria

. Patients found unsuitable preoperatively for a resurfacing prosthesis
. Patients aged 85 or older
. Patients with rheumatoid arthritis
. Patients who previously had undergone shoulder alloplasty or other major shoulder surgery (more than just diagnostic arthroscopy)
. Patients unable to avoid NSAID after surgery
. Patients requiring regular systemic steroid treatment
. Female patients taking hormone substitution
. Patients with metabolic bone disease