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NuShield in Surgical Peroneal Tendon Repair

Primary Purpose

Tendon Injuries, Tendinopathy

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

NuShield

About this trial

This is an interventional treatment trial for Tendon Injuries focused on measuring Tendon Surgery, NuShield

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Central Research Associates, Inc.Recruiting
University of Colorado Health Orthopedics Clinic - Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

NuShield

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Adverse Events

Evaluations of safety will include serious adverse events or observed and/or volunteered adverse events.

Swelling assessment by investigator

Circumferential measurement of the limbs. Change in swelling measured in cm

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

Tegner Activity Scale

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)

Patient reported outcome (PRO) measurement of stiffness and swelling (1-5); with 1 indicating better outcomes and 5 indicating worse outcomes

Full Information

NCT ID

NCT03828916

First Posted

July 20, 2018

Last Updated

January 13, 2020

Sponsor

NuTech Medical, Inc

Collaborators

Organogenesis

1. Study Identification

Unique Protocol Identification Number

NCT03828916

Brief Title

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

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 30, 2019 (Actual)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NuTech Medical, Inc

Collaborators

Organogenesis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tendon Injuries, Tendinopathy

Keywords

Tendon Surgery, NuShield

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NuShield

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

NuShield

Intervention Description

SOC surgery with the addition of NuShield

Primary Outcome Measure Information:

Title

VAS Foot and Ankle Pain

Description

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

Time Frame

6 Months

Title

FAAM Sports Subscale

Description

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

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Evaluations of safety will include serious adverse events or observed and/or volunteered adverse events.

Time Frame

up to 1 year

Title

Swelling assessment by investigator

Description

Circumferential measurement of the limbs. Change in swelling measured in cm

Time Frame

6 and 12 months

Title

PROMIS Global Health Subscale

Description

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

Time Frame

6 and 12 months

Title

Tegner Activity Scale

Description

Tegner Activity Scale (scale 0-10). Changes from baseline; with 0 indicating worse outcomes and 10 indicating better outcomes

Time Frame

6 and 12 months

Title

Foot and Ankle Outcome Instrument, Questions 1 and 2 (subscale)

Description

Patient reported outcome (PRO) measurement of stiffness and swelling (1-5); with 1 indicating better outcomes and 5 indicating worse outcomes

Time Frame

6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katie Mowry

Phone

205-800-8301

kmowry@organo.com

Facility Information:

Facility Name

Central Research Associates, Inc.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shannon Helton, RN

Phone

205-327-1077

shannon@centraltrials.com

First Name & Middle Initial & Last Name & Degree

Norman Waldrop, M.D.

Facility Name

University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

720-848-1900

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

NuShield in Surgical Peroneal Tendon Repair

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