Registry of Avive® Soft Tissue Membrane Utilization in Selected Applications of Acute Trauma of the Upper Extremity

NCT ID: NCT03943134

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-12-17

Brief Summary

A registry study to evaluate the role of Avive® Soft Tissue Membrane in the management of nerve injury associated with acute trauma in the upper extremity.

Detailed Description

This is a multicenter outcomes registry study of Avive® Soft Tissue Membrane in the management of nerve injuries associated with selected upper extremity acute trauma. The study will evaluate clinical condition, economic impact, and functional outcomes.

Conditions

Acute Upper Extremity Trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Avive® Soft Tissue Membrane

Subjects with utilization of Avive® Soft Tissue Membrane on an impacted but intact nerve during a surgical procedure for one of the following targeted acute upper extremity traumas (selected injuries): Spaghetti Wrist, Distal Radius Fracture, Medial Epicondyle Fracture, Flexor Tenolysis at Wrist, and Ballistic Injuries in the Forearm and/or Hand.

Minimally Processed Human Umbilical Cord Membrane

Intervention Type: OTHER

Implantation of minimally processed human umbilical cord membrane at the time of surgery

Standard Surgical Procedures - Control Arm

Subjects who have undergone surgical procedures for the same selected injuries, but without placement of a surgical implant on an impacted but intact nerve.

Standard Surgical Procedures

Intervention Type: OTHER

Standard surgical intervention for at least one targeted acute upper extremity trauma

Interventions

Minimally Processed Human Umbilical Cord Membrane

Implantation of minimally processed human umbilical cord membrane at the time of surgery

Intervention Type: OTHER

Standard Surgical Procedures

Standard surgical intervention for at least one targeted acute upper extremity trauma

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Subjects 5 to 70 years of age, inclusive;

2. Sign and date an IRB/IEC -approved written informed consent form (ICF) prior to initiation of any study activities;

1. Group One only: Subject enrollment (ICF completion) must be completed within 2 weeks (7-14 days) post-operatively of the targeted surgical procedure;

2. Group Two Retrospective subjects only: Sign and date an IRB/IEC - approved written informed consent form (ICF) prior to initiation of any study activities if required per the governing IRB;

3. Group One only: Subjects who have undergone placement of Avive® Soft Tissue Membrane over at least one exposed nerve, circumferentially, or as an overlay between the exposed nerve(s) and the surrounding wound bed during surgical intervention following one or more of the following targeted acute upper extremity traumas (selected injuries): Spaghetti Wrist, Distal Radius Fractures, Medial Epicondyle Fractures, Flexor Tenolysis at Wrist, and/or Ballistic Injuries in the Forearm and/or Hand. This surgical intervention must have been completed within 60 days from the date of injury;

4. Group Two only: Subjects who have undergone surgical intervention for one or more of the following targeted acute upper extremity traumas (selected injuries): Spaghetti Wrist, Distal Radius Fractures, Medial Epicondyle Fractures, Flexor Tenolysis at Wrist, and Ballistic Injuries in the Forearm and/or Hand in the past 5 years without placement of a surgical implant over the exposed nerve, circumferentially, or as an overlay between the exposed nerve(s) and the surrounding wound bed during surgical intervention. This surgical intervention must have been completed within 60 days from the date of injury;

5. Group Two only: Subjects must have at least 1 qualifying post-operative injury assessment;

6. Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.

Exclusion Criteria

1. Subjects with complete transection of all nerves affected by one or more of the following selected injuries: Spaghetti Wrist, Distal Radius Fractures, Medial Epicondyle Fractures, Flexor Tenolysis at Wrist, and Ballistic Injuries in the Forearm and/or Hand. Subjects with nerve transection(s) must also have ≥1 affected nerve intact (non-transected) for treatment with Avive® Soft Tissue Membrane (Group One) or without treatment with a surgical implant (Group Two);

2. Subjects with Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus requiring regular insulin therapy;

3. Subjects who are currently receiving, or have previously received, treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of the neural and/or vascular system;

4. Subjects that are currently taking, or have previously used, a medication that is known to cause peripheral neuropathy;

5. Subjects with a history of chronic ischemic condition of the upper extremity; and

6. Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axogen Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Florida Orthopaedic Institute

Tampa, Florida, United States

Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

Upstate Hand Center

Spartanburg, South Carolina, United States

Countries

United States

Other Identifiers

ASM-CP-001

Identifier Type: -

Identifier Source: org_study_id