Recruiting

NuShield

Sponsor:

NuTech Medical, Inc

Code:

NCT03828916

Conditions

Tendon Injuries

Tendinopathy

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

NuShield

Study Details

Brief summary:

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

Conditions

Tendon Injuries

Tendinopathy

Study ID

NCT03828916

Start date

Jan 30, 2019

Status verified date

Jan, 2020

Completion date

Jun, 2021

Anticipated

Primary completion date

Jun, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: NuShield

Interventions

NuShield

SOC surgery with the addition of NuShield

Primary outcome measure

  • VAS Foot and Ankle Pain [ Time Frame: 6 Months ]
  • FAAM Sports Subscale [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Katie Mowry

205-800-8301kmowry@organo.com

Locations

Central Research Associates, Inc.

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Shannon Helton, RN

205-327-1077shannon@centraltrials.com

Principal Investigator:

Norman Waldrop, M.D.

University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

720-848-1900

More Information

Sponsor

NuTech Medical, Inc

Last update posted

Jan 14, 2020

Last verified

Jan, 2020

Keywords

  • Tendon Surgery
  • NuShield

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NuTech Medical, Inc on 2020-01-14.