NCT03828916

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2.3 years

First QC Date

July 20, 2018

Last Update Submit

January 13, 2020

Conditions

Tendon InjuriesTendinopathy

Keywords

Tendon SurgeryNuShield

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Adverse Events

    up to 1 year

  • Swelling assessment by investigator

    6 and 12 months

  • PROMIS Global Health Subscale

    6 and 12 months

  • Tegner Activity Scale

    6 and 12 months

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

    6 and 12 months

Study Arms (1)

NuShield

OTHER
Other: NuShield

Interventions

NuShieldOTHER

SOC surgery with the addition of NuShield

NuShield

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Research Associates, Inc.

Birmingham, Alabama, 35205, United States

RECRUITING

University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Tendon InjuriesTendinopathy

Condition Hierarchy (Ancestors)

Wounds and InjuriesMuscular DiseasesMusculoskeletal Diseases

Central Study Contacts

Katie Mowry

CONTACT

205-800-8301kmowry@organo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2018

First Posted

February 4, 2019

Study Start

January 30, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)