NCT03828916

NuShield in Surgical Peroneal Tendon Repair

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: NuTech Medical, Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tendon Injuries
• Tendinopathy

Interventions

Type	Name	Description
OTHER	NuShield	SOC surgery with the addition of NuShield

Timeline

• Start date: 2019-01-30
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-02-04
• Last updated: 2020-01-14

Locations

2 sites across 1 country: United States