An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal

Not Applicable

Completed

• Conditions: Adhesions of Soft Tissue
• Interventions: Other: Scheduled removal of posterior instrumentation without AmnioFix; Other: Scheduled removal of posterior instrumentation with AmnioFix

• Registration Number: NCT01357187
• Lead Sponsor: MiMedx Group, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-20
• Study Start: 2011-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Scheduled removal of posterior instrumentation without AmnioFix	-
Treatment	Scheduled removal of posterior instrumentation with AmnioFix	-

Primary Outcome Measures

Name	Time	Method
Tenacity and frequency of soft tissue adhesion	At the time of removal of segmental posterior lumbar instrumentation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Virginia Spine Institute; 🇺🇸 Reston, Virginia, United States