Acute Upper Extremity Trauma Clinical Trial
— ASSISTOfficial title:
A Multicenter, Ambispective, Clinical Outcomes Registry Study of Avive® Soft Tissue Membrane Utilization in Selected Applications of Acute Trauma of the Upper Extremity
| Verified date | April 2021 |
| Source | Axogen Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Active, not recruiting |
| Enrollment | 7 |
| Est. completion date | October 2022 |
| Est. primary completion date | October 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 70 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Indiana Hand to Shoulder Center | Indianapolis | Indiana |
| United States | Upstate Hand Center | Spartanburg | South Carolina |
| United States | Florida Orthopaedic Institute | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Axogen Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | 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). | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | 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". | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | 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 | Pediatric patients will be assessed for changes in patient reported outcomes using the FPS-R. The Faces Pain Scale - Revised (FPS-R) is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widelya accepted calculated 0-to-10 metric. The scale shows a close linear relationship with visual analog pain scales across the age range of 4-16 years. The calculated score ranges from 0 ("no pain") to 10 ("very much pain"). | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | 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 | Adult patients will be assessed for changes in patient reported health status using the SF-36 patient reported health survey. The SF-36 measures overall health status and consists of eight scaled scores which are the weighted sums of the questions in their section. Each scale is directly translated into a 0-100 metric scale. Scoring ranges from 0 (maximum disability to 100 (no disability). | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | Changes in KINDL Health-Related Quality of Life questionnaire for children at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks | The KINDL is a generic quality of life instrument used to assess Health-Related Quality of Life in children and adolescents aged 3 years and older. The questionnaire is comprised of 24 items which assess various quality of life domains using 5-point Likert scales. Calculated scores range from 0 (lower quality of life) to 100 (higher quality of life). | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | Change in Patient Rated Wrist Evaluation | Patients will be assessed for changes in patient reported outcomes using the Patient Rated Wrist Evaluation (PRWE)(Applicable to Injuries Affecting the Wrist) | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | Change in Sensory Function as measured by Medical Research Council Classification (MRCC) for Sensory Recovery | Patients will be assessed for changes in 2-Point Discrimination on a scale from 0 to 4 with 0 representing no sensation and 4 representing a 2-point discrimination measure between 2-6 representing normal sensation. | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | Change in Motor Function as measured by Medical Research Council Classification (MRCC) for Motor Recovery | Patients will be assessed for changes in muscle strength measured on a scale from 0 to 5, with 0 equal to no movement and 5 equal to normal muscle contraction against resistance. | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | Change in Motor Function as measured by Grip and Pinch Strength | Patients will be assessed for changes in grip and pinch strength measured in kg force | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | Change in Motor Function as measured by Range of Motion | Patients will be assessed for changes in range of motion measured in degrees | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | Change in Tinel's Sign | Patients will be assessed for presence of Tinel's Sign | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | Incidence of Adverse Events Associated with the Placement of Avive Soft Tissue Membrane | Adverse events are defined as any untoward event experienced by a patient that is related to the nerve repair (whether or not considered product related by the Principal Investigator or Sponsor) or any even that has changed adversely in nature, severity or frequency. | 2, 4, 8, 12, 16, 24, and 52 weeks | |
| Primary | Health Care Economic Impact based on Resource Utilization and Associated Costs | Patients will be assessed for cost of procedures, post-procedure medications, rehabilitation, re-hospitalization | 2, 4, 8, 12, 16, 24, and 52 weeks |