CompletedNot Applicable

A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

United States184 participantsStarted 2015-06-26

Plain-language summary

A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).

Who can participate

Age range40 Years – 100 Years

SexALL

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

Exclusion criteria

✕. significant gleno-humeral or acromiohumeral arthritis
✕. full thickness cartilage loss as seen on MRI
✕. gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)
✕. pre-existing deltoid defect or deltoid palsy
✕. major joint trauma, infection or necrosis
✕. partial thickness tears of the supraspinatous
✕. fully reparable rotator cuff tear \[Tear of less than 5 cm in diameter (or \< 4 cm2) with retractable tendon that can be fully repaired\]

What they're measuring

Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs.

Timeframe: Baseline to month 12

Trial details

NCT IDNCT02493660

SponsorOrthoSpace Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-02-29

Results submitted2021-05-19

View on ClinicalTrials.gov More Rotator Cuff Syndrome trials