Trials Sponsors Conditions Drugs Pricing

Conditions

Full-thickness Rotator Cuff Tear

Keywords

rotator cuffPEMFPulsed Electromagnetic FieldRotator Cuff Repairadjunctive therapy

Outcome Measures

Primary Outcomes (1)

retear rate
A reduction in retear rates in subjects adjunctively treated with PEMF compared with those treated with a placebo (inactive) RCStim PEMF device following surgical repair of full thickness rotator cuff tears.
12 months

Secondary Outcomes (2)

Muscle Strength
12 months
Penn Shoulder Score
12 months

Study Arms (2)

Active PEMF

ACTIVE COMPARATOR

Subjects have 2 out of 3 chance to get the active device which emits a pulsed electromagnetic field (PEMF) from the RCStim Model 1114 device (right and left side models available). Double-blind randomization.

Device: RCStim Model 1114

Control/placebo PEMF

SHAM COMPARATOR

Subjects have a 1 out of 3 chance to get the control/placebo device which does not emit a pulsed electromagnetic field (PEMF) from the RCStim Model 1114 device (right and left side models available). Double-blind randomization.

Device: RCStim Model 1114

Interventions

RCStim Model 1114Device

Active device emits PEMF signal; placebo/control device does not emit PEMF signal

Also known as: Orthofix rotator cuff soft tissue stimulator

Active PEMFControl/placebo PEMF

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Orthofix Inc.
Industrylead

Study Sites (23)

The CORE Institute

Phoenix, Arizona, 85023, United States

Stanford University

Redwood City, California, 94063, United States

UCSF Orthopedics

San Francisco, California, 94158, United States

Sabesan Orthopedics Research

Atlantis, Florida, 33462, United States

Coastal Orthopedics and Sports Medicine

Bradenton, Florida, 34209, United States

Holy Cross Hospital

Fort Lauderdale, Florida, 33334, United States

Andrews Institute

Gulf Breeze, Florida, 32561, United States

Enrollment

377 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 13, 2017

Study Start

January 15, 2018

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Active PEMF

Control/placebo PEMF

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (23)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Active PEMF

Control/placebo PEMF

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (23)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations