NuShield in Surgical Peroneal Tendon Repair

January 13, 2020 updated by: NuTech Medical, Inc

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

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

Study Overview

Status

Unknown

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Central Research Associates, Inc.
        • Contact:
        • Principal Investigator:
          • Norman Waldrop, M.D.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus
        • Contact:
          • Phone Number: 720-848-1900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: NuShield
SOC surgery with the addition of NuShield

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Foot and Ankle Pain
Time Frame: 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
6 Months
FAAM Sports Subscale
Time Frame: 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
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: up to 1 year
Evaluations of safety will include serious adverse events or observed and/or volunteered adverse events.
up to 1 year
Swelling assessment by investigator
Time Frame: 6 and 12 months
Circumferential measurement of the limbs. Change in swelling measured in cm
6 and 12 months
PROMIS Global Health Subscale
Time Frame: 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
6 and 12 months
Tegner Activity Scale
Time Frame: 6 and 12 months
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)
Time Frame: 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
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • RD2018-01-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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