Status:
UNKNOWN
NuShield in Surgical Peroneal Tendon Repair
Lead Sponsor:
NuTech Medical, Inc
Collaborating Sponsors:
Organogenesis
Conditions:
Tendon Injuries
Tendinopathy
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the use of NuShield in subjects requiring surgical tendon repair.
Detailed Description
The objective of this clinical trial is to evaluate both the safety and efficacy of using the NuShield® allograft in addition to standard of care surgical procedures in subjects requiring surgical rep...
Eligibility Criteria
Inclusion
- Ages 18 to 60 inclusive
- 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
- BMI equal to or greater than 35
- 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
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03828916
Start Date
January 30 2019
End Date
June 1 2021
Last Update
January 14 2020
Active Locations (2)
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1
Central Research Associates, Inc.
Birmingham, Alabama, United States, 35205
2
University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus
Aurora, Colorado, United States, 80045