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 range50 Years

SexALL

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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.

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

View on ClinicalTrials.gov More Rotator Cuff Tear trials