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

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ClinicalTrials.gov Identifier: NCT03943134
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Axogen Corporation

Tracking Information
First Submitted Date May 6, 2019
First Posted Date May 9, 2019
Last Update Posted Date May 9, 2019
Actual Study Start Date December 1, 2018
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2019)
  • Changes in QuickDASH (Disabilities of Arm, Shoulder, Hand) score at 2,4,8,12,16,24, and 52 post-operative weeks (Adult subjects only). [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 weeks ]
    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).
  • 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) [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 weeks ]
    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).
  • Change in Visual Analogue Scale (VAS) For Pain Score at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 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".
  • 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 [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 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").
  • 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 [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 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).
  • Changes in KINDL Health-Related Quality of Life questionnaire for children at 2, 4, 8, 12, 16, 24, and 52 post-operative weeks [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 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).
  • Change in Patient Rated Wrist Evaluation [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 weeks ]
    Patients will be assessed for changes in patient reported outcomes using the Patient Rated Wrist Evaluation (PRWE)(Applicable to Injuries Affecting the Wrist)
  • Change in Sensory Function as measured by Medical Research Council Classification (MRCC) for Sensory Recovery [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 weeks ]
    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.
  • Change in Motor Function as measured by Medical Research Council Classification (MRCC) for Motor Recovery [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 weeks ]
    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.
  • Change in Motor Function as measured by Grip and Pinch Strength [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 weeks ]
    Patients will be assessed for changes in grip and pinch strength measured in kg force
  • Change in Motor Function as measured by Range of Motion [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 weeks ]
    Patients will be assessed for changes in range of motion measured in degrees
  • Change in Tinel's Sign [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 weeks ]
    Patients will be assessed for presence of Tinel's Sign
  • Incidence of Adverse Events Associated with the Placement of Avive Soft Tissue Membrane [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 weeks ]
    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.
  • Health Care Economic Impact based on Resource Utilization and Associated Costs [ Time Frame: 2, 4, 8, 12, 16, 24, and 52 weeks ]
    Patients will be assessed for cost of procedures, post-procedure medications, rehabilitation, re-hospitalization
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects who have had surgical intervention for one or more of the targeted acute upper extremity traumas
Condition Acute Upper Extremity Trauma
Intervention
  • Other: Minimally Processed Human Umbilical Cord Membrane
    Implantation of minimally processed human umbilical cord membrane at the time of surgery
  • Other: Standard Surgical Procedures
    Standard surgical intervention for at least one targeted acute upper extremity trauma
Study Groups/Cohorts
  • 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.
    Intervention: Other: Minimally Processed Human Umbilical Cord Membrane
  • 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.
    Intervention: Other: Standard Surgical Procedures
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 7, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Erick W DeVinney 386-462-6800 clinicalresearch@axogeninc.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03943134
Other Study ID Numbers ASM-CP-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Axogen Corporation
Study Sponsor Axogen Corporation
Collaborators Not Provided
Investigators Not Provided
PRS Account Axogen Corporation
Verification Date May 2019