| Condition or disease | Intervention/treatment |
|---|---|
| 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 |
|---|---|
|
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.
|
Other: Minimally Processed Human Umbilical Cord Membrane
Implantation of minimally processed human umbilical cord membrane at the time of surgery
|
|
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.
|
Other: Standard Surgical Procedures
Standard surgical intervention for at least one targeted acute upper extremity trauma
|
| 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 | |||||
|---|---|---|---|---|---|
| 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 |
||||
| 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 | ||||
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* 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 | ||||