Clinical trial NCT03943134: Registry of Avive® Soft Tissue Membrane Utilization in Selected Applications of Acute Trauma of the Upper Extremity
Official title: A Multicenter, Ambispective, Clinical Outcomes Registry Study of Avive® Soft Tissue Membrane Utilization in Selected Applications of Acute Trauma of the Upper Extremity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Upper Extremity Trauma
Keywords: Acute Trauma
Upper Extremity Trauma
Acute Upper Extremity Trauma
Avive
Peripheral Nerve Injury
Nerve Repair
Lead sponsor: Axogen Corporation
Sponsor class: INDUSTRY
First posted: 2019-05-09
Enrollment: 7
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have had surgical intervention for one or more of the targeted acute upper extremity traumas

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.

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.

Primary outcomes:
measure: Changes in QuickDASH (Disabilities of Arm, Shoulder, Hand) score at 2,4,8,12,16,24, and 52 post-operative weeks (Adult subjects only).
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: 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)
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Change in Visual Analogue Scale (VAS) For Pain Score at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Changes in Reported Pain Using the Faces Pain Scale-Revised Scale (FPS-R) assessment at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Changes in patient reported health status Using SF-36 patient reported health survey at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Changes in KINDL Health-Related Quality of Life questionnaire for children at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Change in Patient Rated Wrist Evaluation
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Change in Sensory Function as measured by Medical Research Council Classification (MRCC) for Sensory Recovery
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Change in Motor Function as measured by Medical Research Council Classification (MRCC) for Motor Recovery
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Change in Motor Function as measured by Grip and Pinch Strength
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Change in Motor Function as measured by Range of Motion
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Change in Tinel's Sign
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Incidence of Adverse Events Associated with the Placement of Avive Soft Tissue Membrane
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
measure: Health Care Economic Impact based on Resource Utilization and Associated Costs
timeFrame: 2, 4, 8, 12, 16, 24, and 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Indianapolis
country: United States
facility: Indiana Hand to Shoulder Center
state: Indiana
city: Spartanburg
country: United States
facility: Upstate Hand Center
state: South Carolina
Study officials:
References: