CompletedNot Applicable

InSpace™ System Implantation in a Procedure Under Local Anesthesia

Italy45 participantsStarted 2013-01

Plain-language summary

The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.

Who can participate

Age range

50 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

. Age 50 or older.
. Positive diagnostic MRI of the affected shoulder indicating full thickness massive irreparable RCT of at least 5cm in diameter (according to Cofield classification) including fatty infiltration grade III or IV (according to classification of Goutallier).
. Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months.

Exclusion criteria

. Known allergy to the balloon material
. Evidence of significant osteoarthritis or cartilage damage in the shoulder
. Evidence of gleno-humeral instability
. Evidence of major joint trauma, infection, or necrosis in the shoulder
. Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study.
. Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.
. Subjects with worker's compensation claims or other litigation claims related to the shoulder being treated in the study.

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

Change in total shoulder outcome scores (Constant and ASES)

Timeframe: 6 months post implanatation

Trial details

NCT IDNCT02208453

SponsorOrthoSpace Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06

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