Lumbar Disc Prolapse With RadiculopathyEarly Phase 1NCT01970514
Safety Study of ARO Spinal System as an Adjunct to Lumbar Decompression
A Early Phase 1 study testing ARO Spinal System in people with Lumbar Disc Prolapse With Radiculopathy, run by ARO Medical at 1 site in Denmark.
Trial summary
To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess preliminary cost/benefit analysis in patients undergoing decompression surgery for symptomatic lumbar disc herniations. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lumbar Disc Prolapse With Radiculopathy
- What is being tested?
- ARO Spinal System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to Jul 2015
- Phase
- Early Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Radicular pain and evidence of nerve-root irritation lasting 6 weeks or more as evidenced by both:
- Radicular pain - below the knee,
- Nerve root irritation
- positive nerve root tension sign - straight leg raise positive between 30 and 70 degrees, or ii. positive femoral tension sign, or iii. neurologic deficit - asymmetrical depressed reflex or decreased sensation in a dermatomal distribution or weakness in a myotomal distribution.
- Primary one-level posterolateral herniation in the lower lumbar spine (L4-L5 or L5-S1 only) as shown by magnetic resonance (MR) imaging (protrusion, extrusion or sequestered fragment) consistent with the clinical symptoms (both level and side).
- The investigator confirms that the patient is a surgical candidate for discectomy,
Show all 10Show fewer
- The patient has been scheduled for their surgical procedure no more than two months from time of consent,
- 18 years to 55 years of age at time of consent,
- Willing to complete the study requirements and permit agency and sponsor authorized personnel to access medical records,
- Able to understand oral and written Danish.
Who cannot join
- Previous lumbar surgery
- Cauda equine syndrome
- Scoliosis greater than 15 degrees
- Osteoporosis
- Segmental instability (> 10 degrees angular motion or >4mm translation)
- Vertebral fractures
Show all 14Show fewer
- Spinal Infections
- Spinal tumors
- Inflammatory spondyloarthropathy
- Pregnancy or the intent to become pregnant in the following year
- Comorbid conditions contraindicating surgery
- Multiple herniations
- Known allergy to titanium, aluminum or vanadium
- Female patients of childbearing age, who are not willing to use adequate contraception specified as: intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). It is accepted in certain cases to include subjects having a sterilized permanent partner or subjects using double barrier contraceptive methods which is a condom combined with a diaphragm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporary Axial Rotation Stabilization for Lumbar Disc Prolapse Surgery With the ARO® Spinal System: A Non-randomized Prospective Analysis of Clinical Efficacy, Safety and Cost Effectiveness
To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess preliminary cost/benefit analysis in patients undergoing decompression surgery for symptomatic lumbar disc herniations.
The general hypothesis is that the ARO significantly improves outcomes in patients undergoing decompression surgery for symptomatic lumbar disc herniations.
Read the detailed description
Not provided
- Conditions
- Lumbar Disc Prolapse With Radiculopathy
- Being tested
- ARO Spinal System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARO Spinal SystemDevice
The device provides an internal axial rotation orthosis (ARO) for patients being surgically treated for herniated nucleus pulposus (HNP).
| Study group | Role | What they receive |
|---|---|---|
| ARO Spinal System | Experimental | ARO Spinal System Receives: Device: ARO Spinal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile compared to historical controls and improvement in leg and back pain
Measured: One year
Secondary outcomes (3)
Oswestry Disability Index (ODI) improvement is superior to historical control
Measured: 1 year
VAS back pain improvement is superior to historical control
Measured: 1 year
VAS leg pain improvement is superior to historical control,
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startApr 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc Prolapse With RadiculopathyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARO Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cody Bunger, MD, DrMedSc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970514
- Sponsor's protocol ID
- ARO-01
- Status last verified
- Jan 2015
- First submitted
- 23 Oct 2013
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Axial Rotation Stabilization for Lumbar Disc Prolapse Surgery With the ARO® Spinal System: A Non-randomized Prospective Analysis of Clinical Efficacy, Safety and Cost Effectiveness
- ClinicalTrials.gov ID
- NCT01970514
- Acronym / sponsor ID
- ARO-01
- Conditions
- Lumbar Disc Prolapse With Radiculopathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ARO MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 28 Oct 2013 (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.
To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess preliminary cost/benefit analysis in patients undergoing decompression surgery for symptomatic lumbar disc herniations.
The general hypothesis is that the ARO significantly improves outcomes in patients undergoing decompression surgery for symptomatic lumbar disc herniations.
Detailed description
Not provided
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARO Spinal System | Experimental | Device: ARO Spinal SystemARO Spinal System |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Radicular pain and evidence of nerve-root irritation lasting 6 weeks or more as evidenced by both:
- Primary one-level posterolateral herniation in the lower lumbar spine (L4-L5 or L5-S1 only) as shown by magnetic resonance (MR) imaging (protrusion, extrusion or sequestered fragment) consistent with the clinical symptoms (both level and side).
- The investigator confirms that the patient is a surgical candidate for discectomy,
- The patient has been scheduled for their surgical procedure no more than two months from time of consent,
- 18 years to 55 years of age at time of consent,
Key exclusion criteria (14 listed)
- Previous lumbar surgery
- Cauda equine syndrome
- Scoliosis greater than 15 degrees
- Osteoporosis
- Segmental instability (> 10 degrees angular motion or >4mm translation)
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 |
|---|---|---|
| ARO Spinal SystemThe device provides an internal axial rotation orthosis (ARO) for patients being surgically treated for herniated nucleus pulposus (HNP). | Device | ARO Spinal System |
Primary outcome
Safety profile compared to historical controls and improvement in leg and back pain
Time frame: One year
3 secondary outcomes
Oswestry Disability Index (ODI) improvement is superior to historical control
Time frame: 1 year
VAS back pain improvement is superior to historical control
Time frame: 1 year
VAS leg pain improvement is superior to historical control,
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
Related trials for Lumbar Disc Prolapse With Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
Recruiting
Acute Effects of Neurodynamics on Strength and Endurance in Athletes
Sciatic Leg Pain, Hamstring Muscle Tightness
Recruiting
High-Intensity Laser Therapy Versus Transforaminal Epidural Steroid Injection in Chronic Lumbar Disc Herniation-Related Low Back and Radicular Pain
Lumbar Disc Herniation, Chronic Low Back Pain
Recruiting
FINDISC-Pain, Finnish Discectomy Trial on the Benefits and Harms of Surgery in Patients With Lumbar Disc Herniation
Lumbar Disc Herniation With Radiculopathy, Sciatica
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.
Cody Bunger, MD, DrMedSc principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ARO Spinal System in people with Lumbar Disc Prolapse With Radiculopathy, run by ARO Medical at 1 site in Denmark.
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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 14 Jan 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 Denmark. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Safety profile compared to historical controls and improvement in leg and back pain (time frame: One year). 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 14 Jan 2015.