Adhesions of Soft Tissue
Conditions
Keywords
Lumbar pathology, requiring elective lumbar interbody fusion
Brief summary
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.
Interventions
OTHERScheduled removal of posterior instrumentation with AmnioFix
OTHERScheduled removal of posterior instrumentation without AmnioFix
Sponsors
MiMedx Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tenacity and frequency of soft tissue adhesion | At the time of removal of segmental posterior lumbar instrumentation |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of intra-operative complications | At the time of removal of segmental posterior lumbar instrumentation |
Countries
United States
Outcome results
None listed