NuShield in Surgical Peroneal Tendon Repair

Study Overview
=================
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

Official Title
-----------------
Single Arm Clinical Evaluation of the Safety and Efficacy of the NuShield® Allograft for Peroneal Tendon Repair

Conditions
-----------------
Tendon Injuries, Tendinopathy

Intervention / Treatment
-----------------
* Other: NuShield


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NuShield<br> | Other: NuShield<br>* SOC surgery with the addition of NuShield<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Foot and Ankle Pain | Visual Analogue Scale (VAS) foot and ankle pain. Change in pain intensity scores from baseline. VAS is measured in mm (scale 0-100); with 0 indicating worse outcomes and 100 indicating better outcome | 6 Months | 
| FAAM Sports Subscale | Foot and Ankle Ability Measure (FAAM) Sports Subscale. Changes in FAAM Sport scores from baseline (scale 0-4); with 0 indicating better outcomes and 4 indicating worse outcomes | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Evaluations of safety will include serious adverse events or observed and/or volunteered adverse events. | up to 1 year | 
| Swelling assessment by investigator | Circumferential measurement of the limbs. Change in swelling measured in cm | 6 and 12 months | 
| PROMIS Global Health Subscale | PROMIS® (Patient-Reported Outcomes Measurement Information System) Global Health Subscale. Changes from baseline (scale 1-5); with 5 indicating better outcomes and 1 indicating worse outcomes | 6 and 12 months | 
| Tegner Activity Scale | Tegner Activity Scale (scale 0-10). Changes from baseline; with 0 indicating worse outcomes and 10 indicating better outcomes | 6 and 12 months | 
| Foot and Ankle Outcome Instrument, Questions 1 and 2 (subscale) | Patient reported outcome (PRO) measurement of stiffness and swelling (1-5); with 1 indicating better outcomes and 5 indicating worse outcomes | 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tendon Surgery, NuShield