Status:
RECRUITING
RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures
Lead Sponsor:
AgNovos Healthcare, LLC
Conditions:
Vertebral Compression Fracture
Vertebral Compression
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.
Detailed Description
A maximum of 100 subjects will be treated at up to 10 study sites across Europe. Follow up visits will be conducted at 1 day, 1 month, 3 months, 12 months and 24 months after the procedure. Study enr...
Eligibility Criteria
Inclusion
- Subject is a male or female 50 years of age or older at time of study treatment.
- Criterion omitted
- Subject has only one (1) acute VCF. Subjects are eligible if they have an asymptomatic healed VCF at any non-target vertebral level.
- This VCF meets all of the following criteria:
- Fracture due to diagnosed or presumed underlying osteoporosis
- VCF from T1 to L5 inclusive
- Fracture age ≤6 months at time of treatment
- Target VCF shows loss of height in the anterior or middle portion of the vertebral body of not more than 50% based on X-ray at baseline.
- Target VCF is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI, bone scan, CT, serial radiographs, or other imaging demonstrating acuity.
- Subject has central pain upon palpation over the spinal process at the target vertebral body.
- Subject has failed conservative medical therapy, defined as either having a VAS back pain score of ≥ 70 mm after 24 hours to 6 weeks of conservative care or a VAS back pain score of ≥ 50 mm after 6 weeks of conservative care.
- Subject has an Oswestry Disability Index (ODI) score of ≥ 30%.
- Subject is capable of giving written informed consent to participate in the study.
- The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full length of the study has been documented.
Exclusion
- Target VCF is due to underlying or suspected tumor.
- Target VCF is due to high-energy trauma.
- Target VCF is diagnosed as an osteonecrotic fracture.
- Target VCF has segmental kyphosis of \> 30°.
- Target VCF is unstable including split or burst fractures.
- Subject has had any prior surgical treatment at the target VCF or adjacent vertebral level (above or below VCF).
- Subject has neurologic symptoms, deficits, or radiculopathy related to the VCF.
- Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
- Subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis).
- Subject has spondylolisthesis \> Grade 1 at target vertebral body.
- Subject has pain due to any other condition that requires daily narcotic medication.
- Subject has severe cardiopulmonary deficiencies.
- Subject has a bleeding disorder.
- Subject has a Body Mass Index (BMI) \> 35.
- Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
- Subject has a history of tuberculosis spondylitis.
- Subject has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for five (5) years.
- Subject is on oral or parenteral immune-suppressive drugs.
- Subject has an active bone infection at target VCF.
- Subject has uncontrolled diabetes mellitus, as determined by the judgment of the Investigator.
- Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min.
- Subject has a diagnosed calcium metabolism disorder.
- Subject has known allergies to calcium-based bone void fillers.
- Subject is pregnant or planning to become pregnant during participation in the study.
- In the judgment of the Investigator, the subject is not a good study candidate (e.g., inability to maintain follow-up schedule, comorbidity or poor general physical/mental health, or drug or alcohol abuse issues).
- Subject is currently enrolled in another interventional clinical study.
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04821739
Start Date
May 19 2021
End Date
December 1 2028
Last Update
March 28 2025
Active Locations (4)
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1
Orthopedic University Hospital Friedrichsheim
Frankfurt am Main, Hesse, Germany, 60528
2
Sana Klinikum Offenbach GmbH
Offenbach, Germany
3
Hospital Clinico Universitario de Valladolid
Valladolid, Valladolid, Spain, 47006
4
Vall d'Hebron University Hospital
Barcelona, Spain, 08035