NuShield in Surgical Peroneal Tendon Repair

Last updated: January 13, 2020
Sponsor: NuTech Medical, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tendon Injuries

Sprains

Treatment

N/A

Clinical Study ID

NCT03828916
RD2018-01-01
  • Ages 18-60
  • All Genders

Study Summary

The purpose of this study is to evaluate the use of NuShield in subjects requiring surgical tendon repair.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 becomepregnant during the course of the study, as verified by urine pregnancy test withinone week prior to treatment

  • History of more than two (2) weeks treatment with immuno-suppressants, includingsystemic corticosteroids or cytotoxic chemotherapy within one month prior to initialscreening, or have received such medications during the screening period, or areanticipated to require such medications during the course of the study

  • Taking any investigational drug(s) or therapeutic device(s) within 30 days precedingscreening

  • 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 ofany type

  • Unable to understand the objectives of the trial

  • Presence of any condition(s) which, in the opinion of the investigator, wouldcompromise 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

Study Design

Total Participants: 30
Study Start date:
January 30, 2019
Estimated Completion Date:
June 30, 2021

Study 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 repair of the peroneal tendon. The effects of this treatment will be assessed using:

  • 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

Connect with a study center

  • Central Research Associates, Inc.

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

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