Clinical trial NCT03828916: NuShield in Surgical Peroneal Tendon Repair
Official title: Single Arm Clinical Evaluation of the Safety and Efficacy of the NuShield® Allograft for Peroneal Tendon Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tendon Injuries
Tendinopathy
Keywords: Tendon Surgery
NuShield
Lead sponsor: NuTech Medical, Inc
Sponsor class: INDUSTRY
Collaborators: name: Organogenesis
First posted: 2019-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Eligibility criteria: 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

Primary outcomes:
measure: VAS Foot and Ankle Pain
timeFrame: 6 Months
measure: FAAM Sports Subscale
timeFrame: 6 Months
Secondary outcomes:
measure: Adverse Events
timeFrame: up to 1 year
measure: Swelling assessment by investigator
timeFrame: 6 and 12 months
measure: PROMIS Global Health Subscale
timeFrame: 6 and 12 months
measure: Tegner Activity Scale
timeFrame: 6 and 12 months
measure: Foot and Ankle Outcome Instrument, Questions 1 and 2 (subscale)
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates, Inc.
state: Alabama
city: Aurora
country: United States
facility: University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus
state: Colorado
Study officials:
References: