TerminatedNot Applicable

PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears

Stopped: Interim results suggested that the study was not adequately powered to achieve the primary endpoint: superiority in retear rate reduction in PEMF treatment versus placebo.

United States377 participantsStarted 2018-01-15

Plain-language summary

The primary objective of this study is to prospectively determine, at 12 months post-surgical repair of full thickness rotator cuff tears, the safety and efficacy of treating full thickness rotator cuff repairs with pulsed electromagnetic fields (PEMF). The hypothesis states that exposure to a pulsed electromagnetic field (PEMF) following surgical repair of a full thickness rotator cuff tendon tear reduces tendon re-tear rates. The strength of the shoulder muscles and the levels of pain in subjects after surgical repair of their rotator cuff adjunctively treated with an active PEMF device will also be measured.

Who can participate

Age range21 Years – 80 Years

SexALL

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Inclusion criteria

✓. Subject may be male or female between 21 years of age and 80 years of age at the time of consent.
✓. Subject must have a repairable (≥1 and ≤ 5 cm in the AP direction) full thickness tear of either the supraspinatus tendon or both the supraspinatus and infraspinatus tendons, as determined by MRI and confirmed intra-operatively (pre-debridement) during the surgical repair of the rotator cuff using a calibrated probe.
✓. This must be the first rotator cuff repair surgery on the study shoulder with the following exceptions:
✓. Previous repairs of the teres minor and/or the subscapularis muscles are permitted.
✓. Previous acromioplasties, decompressions, and clavicular fracture repairs are permitted.
✓. Concurrent acromioplasties, subacromial decompressions and/or distal clavicular excisions are permitted.
✓. Concurrent fracture repairs or reconstructions are NOT permitted.
✓. Biceps tenodesis or tenotomy (open or closed) are permitted.

Exclusion criteria

What they're measuring

retear rate

Timeframe: 12 months

Trial details

NCT IDNCT03339492

SponsorOrthofix Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Full-thickness Rotator Cuff Tear trials