ScarringNCT02300909
dHACM in Lumbar Decompression and Microdiscectomy Surgery
A study testing Lumbar Decompression Surgery, Microdiscectomy Surgery and Dehydrated Human Amnion/Chorion Membrane (dHACM) in people with Scarring and Spinal Stenosis, run by MiMedx Group, Inc. at 1 site in United States.
Trial summary
Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scarring, Spinal Stenosis, Herniated Disc
- What is being tested?
- Lumbar Decompression Surgery, Microdiscectomy Surgery and Dehydrated Human Amnion/Chorion Membrane (dHACM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jun 2018
- 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
- Are 18 (eighteen) years of age or older at the time of surgery.
- Patients with single- or multi-level spinal stenosis undergoing open lumbar laminectomy, or patients with single-level herniated nucleus pulposus undergoing single-level lumbar microdiscectomy
- Are willing and able to return for the scheduled follow-up visits, follow post operative instructions and undergo the required radiographic exams for up to 5 time points between 4 weeks and 24 months post-surgery (6 weeks ± 2 weeks, 12 weeks ± 2 weeks, 6 months ±1 month, 1 year±2 months, and 2 years ±2 months post-surgery), including one study MRI-scan at 12 weeks ±2 weeks for the first 20 patients enrolled.
- Are willing and able to sign study specific informed consent.
Who cannot join
- Non-English speaking patients
- Non-surgical candidate defined as any patient deemed by the surgeon not to be a surgical candidate cannot participate for the following reasons: that patient does not meet indications for lumbar laminectomy or microdiscectomy surgery, patient has a contraindication to surgery such as medical comorbidities, pregnancy, etc.
- Allergic to aminoglycoside antibiotics
- Is a prisoner
- Is involved in worker's compensation or other litigation relative to the spine injury
- Has a history of drug or alcohol abuse within the last 12 months
Show all 12Show fewer
- Is currently participating in another drug or device clinical trial
- Previous spinal surgery
- History of deformity, mechanical instability, or spinal fusion requirement
- History of hard- or soft-tissue spinal infection
- Has signs or symptoms of any disease, such as autoimmune disease, which could result in allograft failure, or has experienced allograft failure in the past
- Patients unable to undergo a MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: A Randomized, Single Blind, Controlled Trial of Clinical Outcomes of Dehydrated Human Amnion/Chorion Membrane (dHACM) in Lumbar Decompression and Microdiscectomy Surgery
Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.
Read the detailed description
The objective of this prospective study is to evaluate the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients randomized to one of two groups: 1) without dHACM (control) or 2) dHACM.
- Conditions
- Scarring, Spinal Stenosis, Herniated Disc
- Being tested
- Lumbar Decompression Surgery, Microdiscectomy Surgery, Dehydrated Human Amnion/Chorion Membrane (dHACM)
- Medical subject headings
- Cicatrix, Spinal Stenosis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Decompression SurgeryProcedure or surgery
Lumbar Decompression Surgery
Microdiscectomy SurgeryProcedure or surgery
Microdiscectomy Surgery
Dehydrated Human Amnion/Chorion Membrane (dHACM)Other
Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)
| Study group | Role | What they receive |
|---|---|---|
| dHACM | Experimental | Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM) Receives: Procedure: Lumbar Decompression Surgery; Procedure: Microdiscectomy Surgery; Other: Dehydrated Human Amnion/Chorion Membrane (dHACM) |
| Surgery without dHACM | Other | Control Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM Receives: Procedure: Lumbar Decompression Surgery; Procedure: Microdiscectomy Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Patient Functional Outcomes Questionnaire
Measured: 2 years
Secondary outcomes (5)
Re-operation (Number of patients having re-operation during study)
Number of patients having re-operation during study
Measured: 2 years
Scar formation in revision cases
Dissection of scar formation required at re-operation
Measured: 2 years
Quality of Life (VAS Pain)
VAS Pain
Measured: 2 years
Quality of Life (SF-36)
SF-36
Measured: 2 years
Quality of Life
HSS Lumbar Expectations Survey
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarringStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital for Special Surgery, New York
- Responsible party
- Sponsor
- Investigators
- Alexander Hughes, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300909
- Sponsor's protocol ID
- AFLUD001
- Status last verified
- Aug 2018
- First submitted
- 18 Nov 2014
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Blind, Controlled Trial of Clinical Outcomes of Dehydrated Human Amnion/Chorion Membrane (dHACM) in Lumbar Decompression and Microdiscectomy Surgery
- ClinicalTrials.gov ID
- NCT02300909
- Acronym / sponsor ID
- AFLUD001
- Conditions
- Scarring, Spinal Stenosis, Herniated Disc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hospital for Special Surgery, New York
- Study start
- Nov 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 25 Nov 2014 (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.
Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.
Detailed description
The objective of this prospective study is to evaluate the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients randomized to one of two groups: 1) without dHACM (control) or 2) dHACM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dHACM | Experimental | Procedure: Lumbar Decompression Surgery, Procedure: Microdiscectomy Surgery, Other: Dehydrated Human Amnion/Chorion Membrane (dHACM)Lumbar Decompression Surgery or Microdiscectomy Surgery with Application of Dehydrated Human Amnion/Chorion Membrane (dHACM) |
| Surgery without dHACM | Other | Procedure: Lumbar Decompression Surgery, Procedure: Microdiscectomy SurgeryControl Group - Lumbar Decompression Surgery or Microdiscectomy Surgery without application of dHACM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are 18 (eighteen) years of age or older at the time of surgery.
- Patients with single- or multi-level spinal stenosis undergoing open lumbar laminectomy, or patients with single-level herniated nucleus pulposus undergoing single-level lumbar microdiscectomy
- Are willing and able to return for the scheduled follow-up visits, follow post operative instructions and undergo the required radiographic exams for up to 5 time points between 4 weeks and 24 months post-surgery (6 weeks ± 2 weeks, 12 weeks ± 2 weeks, 6 months ±1 month, 1 year±2 months, and 2 years ±2 months post-surgery), including one study MRI-scan at 12 weeks ±2 weeks for the first 20 patients enrolled.
- Are willing and able to sign study specific informed consent.
Key exclusion criteria (12 listed)
- Non-English speaking patients
- Non-surgical candidate defined as any patient deemed by the surgeon not to be a surgical candidate cannot participate for the following reasons: that patient does not meet indications for lumbar laminectomy or microdiscectomy surgery, patient has a contraindication to surgery such as medical comorbidities, pregnancy, etc.
- Allergic to aminoglycoside antibiotics
- Is a prisoner
- Is involved in worker's compensation or other litigation relative to the spine injury
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 |
|---|---|---|
| Lumbar Decompression SurgeryLumbar Decompression Surgery | Procedure or surgery | Surgery without dHACM, dHACM |
| Microdiscectomy SurgeryMicrodiscectomy Surgery | Procedure or surgery | Surgery without dHACM, dHACM |
| Dehydrated Human Amnion/Chorion Membrane (dHACM)Application of Dehydrated Human Amnion/Chorion Membrane (dHACM) | Other | dHACM |
Primary outcome
Oswestry Disability Index
Time frame: 2 years
Patient Functional Outcomes Questionnaire
5 secondary outcomes
Re-operation (Number of patients having re-operation during study)
Time frame: 2 years
Scar formation in revision cases
Time frame: 2 years
Quality of Life (VAS Pain)
Time frame: 2 years
Quality of Life (SF-36)
Time frame: 2 years
Quality of Life
Time frame: 2 years
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 23 Aug 2018.
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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.
Alexander Hughes, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Decompression Surgery, Microdiscectomy Surgery and Dehydrated Human Amnion/Chorion Membrane (dHACM) in people with Scarring and Spinal Stenosis, 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 12 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 23 Aug 2018. 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?
Oswestry Disability Index (time frame: 2 years). 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 23 Aug 2018.