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 range

21 Years – 80 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

. 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.

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

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

Plain-language summary

Who can participate

Age range

21 Years – 80 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

. 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.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria