NuShield in Surgical Peroneal Tendon Repair

Not Applicable

• Conditions: Tendinopathy; Tendon Injuries
• Interventions: Other: NuShield

• Registration Number: NCT03828916
• Lead Sponsor: NuTech Medical, Inc

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

Study Timeline

• Study First Submitted: 2018-07-20
• Study Start: 2019-01-30
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NuShield	NuShield	-

Primary Outcome Measures

Name	Time	Method
FAAM Sports Subscale	6 Months	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
VAS Foot and Ankle Pain	6 Months	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Central Research Associates, Inc.; 🇺🇸 Birmingham, Alabama, United States

University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States