Adhesions of Soft TissueNCT01357187
An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal
A study testing Scheduled removal of posterior instrumentation with AmnioFix and Scheduled removal of posterior instrumentation without AmnioFix in people with Adhesions of Soft Tissue, run by MiMedx Group, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesions of Soft Tissue
- What is being tested?
- Scheduled removal of posterior instrumentation with AmnioFix and Scheduled removal of posterior instrumentation without AmnioFix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Effect of the AmnioFix™ Amniotic Membrane Allograft on Scar Tissue and Adhesions in Patients Undergoing Posterior Instrumentation Removal
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.
- Conditions
- Adhesions of Soft Tissue
- Being tested
- Scheduled removal of posterior instrumentation with AmnioFix, Scheduled removal of posterior instrumentation without AmnioFix
- Keywords
- Lumbar pathology, requiring elective lumbar interbody fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled removal of posterior instrumentation with AmnioFixOther
Scheduled removal of posterior instrumentation without AmnioFixOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Not described Receives: Other: Scheduled removal of posterior instrumentation without AmnioFix |
| Treatment | Experimental | Not described Receives: Other: Scheduled removal of posterior instrumentation with AmnioFix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tenacity and frequency of soft tissue adhesion
Measured: At the time of removal of segmental posterior lumbar instrumentation
Secondary outcomes (2)
Presence and extent of scar tissue using histological analysis of the lumbar tissue adjacent to the surgical site
Measured: At the time of removal of segmental posterior lumbar instrumentation
Number of intra-operative complications
Measured: At the time of removal of segmental posterior lumbar instrumentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesions of Soft TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Subach, MD, Principal investigator, Virginia Spine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357187
- Sponsor's protocol ID
- AFPIR001
- Status last verified
- Jun 2014
- First submitted
- 18 May 2011
- Last updated
- 17 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect of the AmnioFix™ Amniotic Membrane Allograft on Scar Tissue and Adhesions in Patients Undergoing Posterior Instrumentation Removal
- ClinicalTrials.gov ID
- NCT01357187
- Acronym / sponsor ID
- AFPIR001
- Conditions
- Adhesions of Soft Tissue
- Keywords
- Lumbar pathology, requiring elective lumbar interbody fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Scheduled removal of posterior instrumentation without AmnioFix |
| Treatment | Experimental | Other: Scheduled removal of posterior instrumentation with AmnioFix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scheduled removal of posterior instrumentation with AmnioFix | Other | Treatment |
| Scheduled removal of posterior instrumentation without AmnioFix | Other | Control |
Primary outcome
Tenacity and frequency of soft tissue adhesion
Time frame: At the time of removal of segmental posterior lumbar instrumentation
2 secondary outcomes
Presence and extent of scar tissue using histological analysis of the lumbar tissue adjacent to the surgical site
Time frame: At the time of removal of segmental posterior lumbar instrumentation
Number of intra-operative complications
Time frame: At the time of removal of segmental posterior lumbar instrumentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
Related trials for Adhesions of Soft Tissue
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Not yet recruiting
Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel
Myoma;Uterus, Adhesion; Uterus, Internal
Active, not recruiting
Use of Nitrous Oxide During Office Hysteroscopy
Abnormal Uterine Bleeding, Postmenopausal Bleeding
RecruitingPhase 2
Evaluation Of Marginal Bone Height Changes And Biting Force In Screw Retained Implant Prostheses Using Reinforced Resin Vs Monolithic Zirconium
Biting Forces, Bone; Change, Diabetic (Manifestation)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Subach, MD principal investigator
Virginia Spine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scheduled removal of posterior instrumentation with AmnioFix and Scheduled removal of posterior instrumentation without AmnioFix in people with Adhesions of Soft Tissue, run by MiMedx Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tenacity and frequency of soft tissue adhesion (time frame: At the time of removal of segmental posterior lumbar instrumentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.