Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-01-30
2021-06-30
Brief Summary
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Detailed Description
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* Questionnaires
* Visual Analog Scale Foot and Ankle (VAS FA)
* FAAM Sport
* PROMIS Global Health SF
* Tegner Activity Scale
* Foot and Ankle Outcomes Instrument (Q1, Q2)
* Swelling assessments
* Ultrasound imaging for tendon thickness, gliding and adhesion formation
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NuShield
NuShield
SOC surgery with the addition of NuShield
Interventions
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NuShield
SOC surgery with the addition of NuShield
Eligibility Criteria
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Inclusion Criteria
* If female, actively practicing a medically relevant method of contraception, abstinent, surgically sterile, or post-menopausal (defined as no menses for at least 12 months)
* Have a diagnosis of one of the following in relation to the peroneal tendon:
* Tendonitis with MRI confirmation
* Synovial inflammation
* Tear
* Diagnosis resulting from acute injury to the tendon
Exclusion Criteria
* Prior injury to the peroneal tendon
* Collagen disorders
* Inflammatory arteriopathies
* Immune compromised
* Diabetic
* Less than 6 months between injury and proposed surgery date
* Steroid injection within the past 6 weeks localized to the treatment area
* Pregnant within the past six (6) months, breast feeding and/or desire to become pregnant during the course of the study, as verified by urine pregnancy test within one week prior to treatment
* History of more than two (2) weeks treatment with immuno-suppressants, including systemic corticosteroids or cytotoxic chemotherapy within one month prior to initial screening, or have received such medications during the screening period, or are anticipated to require such medications during the course of the study
* Taking any investigational drug(s) or therapeutic device(s) within 30 days preceding screening
* History of radiation therapy of the affected foot
* Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
* Currently involved in medical litigation, including Worker's Compensation claims of any type
* Unable to understand the objectives of the trial
* Presence of any condition(s) which, in the opinion of the investigator, would compromise the subject's ability to complete this study
* Having a known history of poor adherence with medical treatment
* Express an unwillingness to receive human allograft tissue
18 Years
60 Years
ALL
No
Sponsors
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Organogenesis
INDUSTRY
NuTech Medical, Inc
INDUSTRY
Responsible Party
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Locations
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Central Research Associates, Inc.
Birmingham, Alabama, United States
University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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RD2018-01-01
Identifier Type: -
Identifier Source: org_study_id
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