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NCT02445118 · ClinicalTrials.gov registry record
Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist
A clinical trial, sponsored by Musculoskeletal Transplant Foundation.
- Completed
- Registry status
- 15
- Enrollment target
NCT02445118: Completed study, sponsored by Musculoskeletal Transplant Foundation.
NCT02445118 is a clinical trial that has completed, run by Musculoskeletal Transplant Foundation. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02445118 has completed, sponsored by Musculoskeletal Transplant Foundation.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
This is a 16 week pilot study to assess short term outcomes of an injectable allograft adipose matrix (AAM) in the subcutaneous space in the dorsum of the wrist. A total of 30 patients will be enrolled at 2 sites and will be followed for sixteen weeks. Volume retention and local skin changes will be observed and documented prior to and following injection at week 0 and at follow up visits at 2, 10 and 16 weeks. Evaluations will be done via photographic analysis at week 0,2,10 and 16 weeks and half of the patients will undergo magnetic resonance imaging at week zero and at week 16. The dominant wrist will serve as a control and will receive no injection. Analysis includes volume retention, tissue analysis, local skin changes and adverse events, if any.
Primary Outcome
Using a volume assessment scale photographs of treated vs. non-treated dorsal wrist will be evaluated by three plastic surgeons, with mean outcomes for each patient documented as final evidence
Interventions
- OTHER Adipose Allograft Matrix (AAM) injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-03 |
What the finished NCT02445118 record still lists
NCT02445118 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Adipose Allograft Matrix (AAM) injection is the first listed.
NCT02445118 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02445118 about?
NCT02445118 is a clinical study titled "Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist". This is a 16 week pilot study to assess short term outcomes of an injectable allograft adipose matrix (AAM) in the subcutaneous space in the dorsum of the wrist. A total of 30 patients will be enrolled at 2 sites and will be followed for sixteen weeks. Volume retention and local skin changes will be...
What is the current status of trial NCT02445118?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2015-05. Estimated completion is 2016-03.
What interventions are being tested in trial NCT02445118?
The interventions under investigation include: Adipose Allograft Matrix (AAM) injection (OTHER).
Who is sponsoring clinical trial NCT02445118?
This trial is sponsored by Musculoskeletal Transplant Foundation, which has 8 total clinical trials registered on ClinicalTrials.gov.
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