Adhesions of Soft Tissue Clinical Trial
Official title:
An Evaluation of the Effect of the AmnioFix™ Amniotic Membrane Allograft on Scar Tissue and Adhesions in Patients Undergoing Posterior Instrumentation Removal
| Verified date | June 2014 |
| Source | MiMedx Group, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The objective of this study is to evaluate the clinical effectiveness of AmnioFix™ in the reduction of the tenacity and frequency of soft tissue adhesions during the removal of segmental posterior lumbar instrumentation.
| Status | Completed |
| Enrollment | 5 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adults (18 years or older) - Diagnosed with lumbar pathology requiring elective lumbar interbody fusion - Willingness to comply to follow-up examinations and diagnostic imaging procedures - Ability to give full written informed consent Exclusion Criteria: - Previous surgical procedure performed at same site - Sign or symptoms of other disease which could result in allograft failure - Require a corpectomy - Participating in another drug or device clinical trial - Pregnant or may become pregnant during the study - Prisoner - Involved in workmen's compensation or other litigation relative to a spine injury - Past medical history of allograft implantation which resulted in graft failure - Any condition requiring treatment above the normal standard of care - Currently taking medications which could affect graft incorporation (supervising physicians discretion) - Auto-Immune disease - Renal failure - Failure to sign or understand informed consent information - History of drug and/or alcohol abuse - Allergic to aminoglycosides |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Virginia Spine Institute | Reston | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| MiMedx Group, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tenacity and frequency of soft tissue adhesion | At the time of removal of segmental posterior lumbar instrumentation | ||
| Secondary | Presence and extent of scar tissue using histological analysis of the lumbar tissue adjacent to the surgical site | At the time of removal of segmental posterior lumbar instrumentation | ||
| Secondary | Number of intra-operative complications | At the time of removal of segmental posterior lumbar instrumentation |