Surgical WoundNCT03536013
Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy
A study testing Other: Full-thickness placental allograft in people with Surgical Wound and Herniation, run by StimLabs at 1 site in United States.
Trial summary
To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound, Herniation
- What is being tested?
- Other: Full-thickness placental allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2018to 1 Aug 2019
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ambulatory with radiating low back and leg pain for greater than 6 months prior to surgery with clinical diagnosis of lumbar protruding disc.
- Consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact.
Who cannot join
- Severe hypertension systolic blood pressure (greater than or equal to 200 mm -Hg or diastolic blood pressure greater than or equal to 182 mm Hg)
- BMI greater than 45 kg/m2
- Subject has had major surgery at the index level
- Is an active smoker or stopped smoking in the last 6 months
- Any pain that could interfere with the assessment of index level pain (e.g. pain in any other part of the spine)
- Active rheumatoid arthritis
Show all 16Show fewer
- Active, local or systemic malignancy such as lung cancer or leukemia
- History of vascular disease or sickle cell anemia
- Use of the following medications:
- No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)
- No systemic treatments that may interfere with safety or efficacy assessments during the study
- No immunosuppressants
- No use of corticosteroids
- Subject is pregnant or plans to become pregnant within 24 months of treatment
- Subject does not provide full consent
- Personal injury, workman's compensation or other legally-related treatment patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Polaris Spine and Neurosurgery
Atlanta, Georgia, 30328
About this study
Official title: A Clinical Investigation Evaluating Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy Outcomes
To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts.
Read the detailed description
The primary objective is to evaluate the efficacy of full thickness placental allograft use in improving back and leg pain, when applied to patients undergoing lumbar microdiscectomy.
- Conditions
- Surgical Wound, Herniation
- Being tested
- Other: Full-thickness placental allograft
- Medical subject headings
- Surgical Wound, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Full-thickness placental allograftOther
A full-thickness placental allograft will be applied to the annulus of the index lumbar level prior to site closure.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 91 patients will undergo a typical lumbar microdiscectomy with the addition of a full-thickness placental allograft after the microdiscectomy has been performed. Receives: Other: Other: Full-thickness placental allograft |
| Control | No intervention | 91 patients will undergo a typical lumbar microdiscectomy without the addition of a full-thickness placental allograft. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
Oswestry Disability Index (ODI)
Measured: 24 months
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
12-Item Short Form Survey (SF12)
Measured: 24 months
Secondary outcomes (1)
Evaluation of post-microdiscectomy reherniation rate.
Reherniation rates will be compared between the experimental and control groups.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start3 May 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies 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
- Model description
- Blind study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- StimLabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Morrison, M.D., Principal investigator, Polaris Spine and Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536013
- Sponsor's protocol ID
- DSP17-002
- Status last verified
- Jun 2024
- First submitted
- 30 Apr 2018
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor will not have access to personally identifying participant information.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation Evaluating Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy Outcomes
- ClinicalTrials.gov ID
- NCT03536013
- Acronym / sponsor ID
- DSP17-002
- Conditions
- Surgical Wound, Herniation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- StimLabsIndustry (pharma, biotech, devices)
- Study start
- 3 May 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 24 May 2018 (actual)
- 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.
To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts.
Detailed description
The primary objective is to evaluate the efficacy of full thickness placental allograft use in improving back and leg pain, when applied to patients undergoing lumbar microdiscectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Blind study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Other: Full-thickness placental allograft91 patients will undergo a typical lumbar microdiscectomy with the addition of a full-thickness placental allograft after the microdiscectomy has been performed. |
| Control | No intervention | –91 patients will undergo a typical lumbar microdiscectomy without the addition of a full-thickness placental allograft. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ambulatory with radiating low back and leg pain for greater than 6 months prior to surgery with clinical diagnosis of lumbar protruding disc.
- Consent and compliance with all aspects of the study protocol, methods, providing data during follow-up contact.
Key exclusion criteria (16 listed)
- Severe hypertension systolic blood pressure (greater than or equal to 200 mm -Hg or diastolic blood pressure greater than or equal to 182 mm Hg)
- BMI greater than 45 kg/m2
- Subject has had major surgery at the index level
- Is an active smoker or stopped smoking in the last 6 months
- Any pain that could interfere with the assessment of index level pain (e.g. pain in any other part of the spine)
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 |
|---|---|---|
| Other: Full-thickness placental allograftA full-thickness placental allograft will be applied to the annulus of the index lumbar level prior to site closure. | Other | Treatment |
Primary outcome
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
Time frame: 24 months
Oswestry Disability Index (ODI)
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy.
Time frame: 24 months
12-Item Short Form Survey (SF12)
1 secondary outcome
Evaluation of post-microdiscectomy reherniation rate.
Time frame: 24 month
Results and safety
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No. The sponsor will not have access to personally identifying participant information.
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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.
Thomas Morrison, M.D. principal investigator
Polaris Spine and Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Other: Full-thickness placental allograft in people with Surgical Wound and Herniation, run by StimLabs 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 2 inclusion and 16 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: stopped early, as of the sponsor's last update on 1 Jul 2024. 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 was stopped early (reason given: Low enrollment.). Results are not available in the source record.
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?
Measuring efficacy of full-thickness placental allograft in reducing back and leg pain post-microdiscectomy. (time frame: 24 months). The study lists 2 primary outcomes in all. 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 1 Jul 2024.