Condition or disease | Intervention/treatment |
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Acute Upper Extremity Trauma | Other: Minimally Processed Human Umbilical Cord Membrane Other: Standard Surgical Procedures |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 7 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
Target Follow-Up Duration: | 12 Months |
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 |
Actual Study Start Date : | December 1, 2018 |
Estimated Primary Completion Date : | October 2022 |
Estimated Study Completion Date : | October 2022 |
Group/Cohort | Intervention/treatment |
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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.
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Other: Minimally Processed Human Umbilical Cord Membrane
Implantation of minimally processed human umbilical cord membrane at the time of surgery
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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.
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Other: Standard Surgical Procedures
Standard surgical intervention for at least one targeted acute upper extremity trauma
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Ages Eligible for Study: | 5 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Sign and date an IRB/IEC -approved written informed consent form (ICF) prior to initiation of any study activities;
Exclusion Criteria:
United States, Florida | |
Florida Orthopaedic Institute | |
Tampa, Florida, United States, 33609 | |
United States, Indiana | |
Indiana Hand to Shoulder Center | |
Indianapolis, Indiana, United States, 46260 | |
United States, South Carolina | |
Upstate Hand Center | |
Spartanburg, South Carolina, United States, 29307 |
Tracking Information | |||||
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First Submitted Date | May 6, 2019 | ||||
First Posted Date | May 9, 2019 | ||||
Last Update Posted Date | May 4, 2021 | ||||
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 |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
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 |
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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 |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Actual Enrollment |
7 | ||||
Original Estimated Enrollment |
200 | ||||
Estimated Study Completion Date | October 2022 | ||||
Estimated Primary Completion Date | October 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 5 Years to 70 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
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 |
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IPD Sharing Statement |
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Responsible Party | Axogen Corporation | ||||
Study Sponsor | Axogen Corporation | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Axogen Corporation | ||||
Verification Date | April 2021 |