NuShield in Surgical Peroneal Tendon Repair

NuTech Medical

Status: Unknown

Conditions: Tendinopathy; Tendon Injuries

Treatments: Other: NuShield

Study type: Interventional

Funder types: Industry

Identifiers

NCT03828916

RD2018-01-01

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

NuShield

Other group

Treatment:

Other: NuShield