NuShield in Surgical Peroneal Tendon Repair

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03828916
• Other study ID #: RD2018-01-01
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: June 2021

Study information

• Verified date: January 2020
• Source: NuTech Medical, Inc
• Contact: Katie Mowry
• Phone: 205-800-8301
• Email: kmowry[@]organo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendinopathy
• Tendon Injuries

Intervention

Other:
• NuShield
SOC surgery with the addition of NuShield

Locations

Country	Name	City	State
United States	University of Colorado Health Orthopedics Clinic - Anschutz Medical Campus	Aurora	Colorado
United States	Central Research Associates, Inc.	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
NuTech Medical, Inc	Organogenesis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Adverse Events	Evaluations of safety will include serious adverse events or observed and/or volunteered adverse events.	up to 1 year
Secondary	Swelling assessment by investigator	Circumferential measurement of the limbs. Change in swelling measured in cm	6 and 12 months
Secondary	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	6 and 12 months
Secondary	Tegner Activity Scale	Tegner Activity Scale (scale 0-10). Changes from baseline; with 0 indicating worse outcomes and 10 indicating better outcomes	6 and 12 months
Secondary	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	6 and 12 months