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

Axogen Corporation7 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Upper Extremity Trauma

Interventions

Minimally Processed Human Umbilical Cord MembraneOTHER

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

Standard Surgical ProceduresOTHER

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (3)

Florida Orthopaedic Institute

Tampa, Florida, United States

Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

Upstate Hand Center

Spartanburg, South Carolina, United States

Outcomes

Primary Outcomes

Changes in QuickDASH (Disabilities of Arm, Shoulder, Hand) score at 2,4,8,12,16,24, and 52 post-operative weeks (Adult subjects only).

Adult patients will be assessed for changes in functional status using the QuickDASH outcomes assessment. The quickDASH is an abbreviated version of the original DASH outcomes measures and is comprised of an 11-item patient reported questionnaire used to assess physical function and severity of symptoms in patients with musculoskeletal disorders of the upper limb. Each of the items in the quickDASH use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula (\[sum of n responses)/n\]-1)(25), where n represents the number of completed items. Computed scores range from 0 (no disability) to 100 (most severe disability).

Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks

Changes in PROMIS Pediatric Upper Extremity/Parent Proxy Upper Extremity (PUE/PPUE) outcomes assessment at 2,4,8,12,16, 24, and 52 post-operative weeks (Pediatric subjects only)

The Patient Reported Outcome Measurement Information System (PROMIS®) - pediatric Related Measures is a set of person-centered measures that evaluates and monitors a patient's physical health and pain (pediatric patients). Short forms containing fixed sets of 4-10 items or questions are included for each domain. All PROMIS scores are presented as T-scores where the T-score is the standardized score with a mean of 50 (range 20-80) and a standard deviation of 10. Higher scores indicate more of the concept being measures where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., fatigue). PROMIS instruments are scored using item-level calibrations based on response patterns by HealthMeasures Scoring Service (https://www.assessmentcenter.net/ac\_scoringservice).

Time frame: 2, 4, 8, 12, 16, 24, and 52 weeks

Change in Visual Analogue Scale (VAS) For Pain Score at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks

The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10 centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing "the worst pain imaginable".

Data from ClinicalTrials.gov

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