Latest Research & Clinical Trials


Arms

1: Experimental Implantation of the Activ-L Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1. Intervention: Device: Activ-L Artificial Disc

2: Active Comparator Implantation of either the ProDisc Total Disc Replacement or the Charité Artificial Disc at one level of the lumbar spine, either L4/L5 or L5/S1. Intervention: Device: ProDisc Total Disc Replacement or Charite Atifical Disc


Assigned Interventions

Device: Activ-L Artificial Disc Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.

Device: ProDisc Total Disc Replacement or Charite Atifical Disc Implantation at one level of the lumbar spine, either L4/L5 or L5/S1.

 

Detailed Description:

The objective of this clinical study is to evaluate the safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine in patients who have been unresponsive to at least six months of prior conservative care. The hypothesis of the study is that the Activ-L Disc is non-inferior to the control (the Charité® Artificial Disc [DePuy Spine] or ProDisc-L® Total Disc Replacement [Synthes Spine]) with respect to the rate of individual subject success at 24 months. Individual subject success is a composite of effectiveness and safety.
 

Eligibility:

Ages Eligible for Study:    18 Years to 60 Years
Genders Eligible for Study:    Both
Accepts Healthy Volunteers:    Yes
 

Criteria:
Inclusion Criteria:
• Age 18 - 60, skeletally mature
• Symptomatic DDD with objective evidence of lumbar DDD, with any of the following characteristics by MRI scan:

instability as defined by ≥ 3mm translation or ≥ 5° angulation.
osteophyte formation of facet joints or vertebral endplates.
decreased disc height of >2mm as compared to the adjacent level.
scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule.
herniated nucleus pulposus.
facet joint degeneration/changes.
vacuum phenomenon.

• Single level symptomatic disease at L4/L5 or L5/S1.

 six months of unsuccessful conservative treatment

• ODI score ≥ 40/100.
• Surgical candidate for an anterior approach to the lumbar spine.
• Back pain at the operative level only, with or without leg pain.
• Back pain VAS score greater than the higher of the two VAS leg pain scores.
• VAS back pain score ≥ 40/100 mm.
• Willing to return for follow-up visits and sign an Informed Consent and HIPAA Authorization.
Exclusion Criteria:
• Previous surgery at any lumbar level, except IDET (Intradiscal Electrothermal Annuloplasty), percutaneous nucleoplasty, or microdiscectomy.
• Chronic radiculopathy, i.e., subject complaint of unremitting pain with a predominance of leg pain symptoms greater than back pain symptoms extending over a period of at least 1 year.
• endplate dimensions smaller than 34.5 mm in medial-lateral and/or 27 mm in the anterior-posterior direction
• Evidence of significant, symptomatic disc degeneration at another lumbar level.
• Preoperative remaining disc height < 3mm
• Myelopathy.
• Previous compression or burst fracture at the affected level.
• Sequestered herniated nucleus pulposus with migration.
• Mid-sagittal stenosis of <8mm (by MRI).
• Degenerative or lytic spondylolisthesis > 3mm.
• Spondylolysis.
• Isthmic spondylolisthesis.
• Lumbar scoliosis (> 11 degrees of sagittal plane deformity).
• Spinal tumor.
• Active systemic infection or infection at the site of surgery.
• Facet ankylosis or severe facet degeneration.
• Continuing steroid use or prior use for more than 2 months.
• History of allergies to any of the device components.
• Pregnancy or planning to become pregnant within the next 2 years.
• Morbid obesity (BMI >35).
• Investigational drug or device use within 30 days.
• Osteoporosis or osteopenia
• Metabolic bone disease.
• Leg pain with migrated sequestrum fragment.
• History of rheumatoid arthritis, lupus, or other autoimmune disorder.
• Ankylosing spondylitis.
• History of HIV/AIDS or hepatitis that precludes surgery.
• History of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolytic disease.
• Current or recent history of illicit drug or alcohol abuse, or dependence as defined as the continued use of alcohol despite the development of social, legal, or health problems.
• Life expectancy <5 years.
• Chemotherapy within past 5 years or any cancer other than non-melanoma skin cancer treated with curative intent within the past 5 years.
• Prior nephrectomy.
• Abdominal adhesions, endometriosis, inflammatory bowel disease, Crohn's disease, diverticulitis, ulcerative colitis or other abdominal pathology that would preclude abdominal surgical approach.
• Insulin-dependent diabetes.
• Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, ALS (amyotrophic lateral sclerosis), or multiple sclerosis.
• History of Pelvic Inflammatory Disease.
• Peritonitis.
• Currently in active spinal litigation as a result of medical negligence.
• Prisoner.
• Psychiatric or cognitive impairment that would interfere with the subject's ability to comply with the study requirements, e.g., Alzheimer's disease.

Purpose

The clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.

Condition

Pathologic Fracture of the Vertebra Due to Osteoporosis 

Intervention

Device: Crosstrees Pod system for PVA

Study Type: Interventional
 

Study Design: 

  • Allocation: Non-Randomized
  • Control: Historical Control
  • Endpoint Classification: Safety/Efficacy Study
  • Intervention Model: Single Group Assignment
  • Masking: Open Label
  • Primary Purpose: Treatment

Official Title: Clinical Evaluation of the Crosstrees Pod™ System for Percutaneous Vertebral Augmentation in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients

Resource links provided by NLM:

MedlinePlus related topics: Fractures Osteoporosis  and U.S. FDA Resources

Further study details as provided by Crosstrees Medical Inc.:

Primary Outcome Measures:
• Clinically significant improvement in pain as measured using a 10 mm Visual Analog Scale (VAS). In this scale 0 means "no pain" and 10 is "Severe pain". A difference of at least 2 points compared to baseline is regarded as clinically relevant. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
• Ambulatory Status/Physical Function [ Time Frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
• Quality of life [ Time Frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
• Neurological Assessment [ Time Frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
• Vertebral Body Morphology [ Time Frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 118
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
 


Arms

Conservative care: No Intervention
Resolution of symptoms during study mandated period of conservative care prior to treatment. 
Treatment arm: Active Comparator
Percutaneous vertebral augmentation using subject devices.
 

Assigned Interventions

Device: Crosstrees Pod system for PVA Device: Crosstrees Pod system for PVA
Minimally invasive spine surgery
Other Names:
• Vertebroplasty
• Kyphoplasty
• PVA
• Vertebral Augmentation

Detailed Description:
Every year in the United States more than 700,000 people suffer from compression fractures of the spinal column , and the number of people affected is much higher across the world. Osteoporosis is the main cause of fractures of the vertebral bodies. Other causes of vertebral fractures include malignant processes including benign lesions (hemangioma) and malignant lesions (metastatic cancers, myeloma), infections and trauma; however, osteoporosis is by far the main cause of this problem.
In a normal person, the vertebral bodies are composed of a porous structure called trabecular or spongy bone encapsulated within a thin external cap of cortical (dense) bone. In a person with osteoporosis, the trabeculae that form the central porous bone become thinner and weaker. When this occurs, the vertebral bodies begin to fracture and become deformed. This deformation of the vertebral bodies is classified into three types, according to the shape: wedge, biconcave, and crush. The degree of severity of these deformations is classified as grade A1.1, grade A1.2, or grade A1.3
The Crosstrees PVA™ Pod™ is a device designed to percutaneously provide controlled delivery of PMMA bone filler material during vertebral augmentation. The Crosstrees PVA System for Percutaneous Vertebral Augmentation (PVA) is designed for use with Crosstrees Fortibrae PMMA. The system is novel in providing the ability to control the delivery of PMMA to the vertebral body without the need for an additional permanent implant to remain within the patient. The Crosstrees System for Percutaneous Vertebral Augmentation will be used with Crosstrees Access Tools, which are regulated as Class I exempt orthopedic manual surgical instruments.
 

Eligibility:
Ages Eligible for Study:    50 Years and older
Genders Eligible for Study:    Both
Accepts Healthy Volunteers:    Yes
 

Criteria
Inclusion Criteria:
1. Patient is at least 50 years old or older.
2. Patient must have a fracture due to diagnosed or presumed underlying primary or secondary osteoporosis (Patients with AO type A1 fractures (all) may be included in the study).
3. Patient must have confirmed acute pain and tenderness over the spine at or near the level of x-ray compression deformity OR positive MRI evaluation.
4. Patient must NOT have more than (3) three vertebral compression fractures located between T4 and L5.
5. Subjects affected vertebral body must have a loss of 0- 60% in vertebral height as compared with the height of an adjacent normal vertebral body confirmed by radiological evaluation.
6. Subject fracture is confirmed by MRI imaging including T1, T2 and STIR-weighted studies to determine the type and presence of fracture(s).
7. Subjects affected vertebral body height and geometry is adequate for insertion of access instruments of 5.2mm OD, as determined by the investigator.
8. Subjects pain score is equal to or greater than 5 according to the visual analog scale (VAS).
9. Patient has been evaluated for hematologic disorders or other conditions affecting blood coagulation.
10. Subjects are suitable candidates for standard vertebroplasty or kyphoplasty procedures.
11. Subject is psychosocially, mentally, and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plans, completing forms, and other study procedures.
12. Subject signed the Informed Consent Form prior to any study related procedures indicating that he/she has been informed of all pertinent aspects of the trial.
13. Failure of conservative treatment prior to inclusion: a. failed conservative treatment arm; b. acute therapy treatment arm.
Exclusion Criteria:
1. Patient has significant vertebral collapse, defined as > 60% of the original height of the vertebral body, as measured against the nearest normal vertebral body. Degree of collapse will be determined by using the height of the nearest normal vertebral body to represent 100% and dividing the height of the collapsed vertebral body by the height of the normal vertebral body.
2. Patient has compromised spinal canal.
3. Patient has spinal stenosis.
4. Patient has painful VCF with fracture age greater than 6 months.
5. Patients has primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
6. Patient has a fracture that extends into the posterior vertebral body wall.
7. Patient has neurological compromise (including myelopathy) and instability
8. Patient has a retropulsion severe enough to cause myelopathy, unless prior surgical decompression is performed.
9. Patient with significant clinical comorbidity that may potentially interfere with long-term data collection or follow-up (e.g., dementia, severe comorbid illness)
10. Patient requires the use of high-dose steroid, IV pain medication, or nerve block to control chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.
11. Patient who may require allogenic bone marrow transplantation during the course of the study.
12. Patient is in need of an open decompression.
13. Patient with burst fracture, and/or pedicle fracture at the treatment level.
14. Patient with a known or suspected allergy to PMMA or allergy to any device material used in the treatment of vertebral fractures. Note that in subjects with allergy to iodine-based contrast, other non-iodine contrast solutions may be used.
15. Patient does not have local pain and tenderness that correlates with MRI evaluation.
16. Patient has a coagulation disorder that cannot be corrected: a. for patients with hematologic disorders or other conditions affecting blood coagulation, a platelet count and internationalized normal ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT) values should be available at time intervals typical of the treatment center. The Investigator is to evaluate the ranges relative to the normal values of the treatment center laboratory.
17. Patient has an active local or systemic infection.
18. Patient has a previous or current treatment for cancer at the affected level.
19. Patient has a previous spine surgery or previous injection of cement at the vertebral levels of the surgical procedure.
20. Patient has diabetes mellitus.
21. Patient has an MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)
22. Patient has an unstable spine as indicated by neurologic deficit, kyphosis greater than 30°, compression greater than 60%, translation greater than 4 mm, interspinous-process widening.
23. Pre-existing conditions contrary to either PVA or vertebroplasty, such as: a. Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Subjects on coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants; b. Any evidence of VB or systemic infection.
24. Patient has a mental deficiency (e.g., psychiatric disorders, Alzheimer's disease, presence of alcohol or drug abuse).
25. Patient is pregnant or is interested in becoming pregnant during the study duration.
26. Patient is a prisoner or ward of the state.
27. Patient expects to relocate more than 50 miles from the study center prior to completion of the study follow-up period.
28. Patient has an AO classification A2, A3, B or C type fracture
29. Patient has hemangioma, malignant fracture, and/or multiple myeloma at the site of the index VCF.

Purpose
To evaluate the safety and effectiveness of the coflex device compared to the control.

Condition
Intervention

Lumbar Spinal Stenosis Device: coflex
Procedure: fusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Multicenter, Prospective, Randomized, Clinical Trial Comparing Stabilization With Coflex vs. Pedicle Screw Fixation and Fusion After Decompression for at Least Moderate Lumbar Spinal Stenosis

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Spinal Stenosis and U.S. FDA Resources

Further study details as provided by Paradigm Spine:

Estimated Enrollment: 460
 


Arms
Conservative care: No Intervention Resolution of symptoms during study mandated period of conservative care prior to treatment. Treatment arm: Active Comparator Percutaneous vertebral augmentation using subject devices. Intervention: Device: Crosstrees Pod system for PVA Assigned Interventions

Device: Crosstrees Pod system for PVA Minimally invasive spine surgery Other Names: • Vertebroplasty • Kyphoplasty • PVA • Vertebral Augmentation

coflex: Experimental
stabilization with coflex
Intervention: Device: coflex Device: coflex
stabilization with coflex
fusion: Active Comparator
pedicle screw fixation and fusion after decompression
Intervention: Procedure: fusion Procedure: fusion
pedicle screw fixation and posterolateral fusion after decompression

Detailed Description:
The objective of this clinical trial is to evaluate the safety and effectiveness of the coflex device compared to a surgical control, posterolateral fusion with autograft bone and pedicle screw fixation, following decompressive laminectomy for the treatment of one or two level lumbar stenosis from L1-L5 that requires surgical decompression, and in patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 1 epidural steroid injection and at least 6 months of conservative treatment.
   Eligibility
Ages Eligible for Study:    40 Years to 80 Years
Genders Eligible for Study:    Both
Accepts Healthy Volunteers:    No
Criteria
Inclusion Criteria:
1. At least moderate lumbar stenosis from L1-L5, at one or two contiguous levels, confirmed by MRI or CT, with up to Grade I spondylolisthesis.
2. Radiographic confirmation of no angular or translatory instability of the spine at index or adjacent levels.
3. VAS back pain score of at least 50mm on a 100mm scale.
4. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion.
5. At least one epidural injection at any prior timepoint, and at least 6 months of prior conservative care without adequate and sustained symptom relief.
6. 40 to 80 years of age.
7. Minimum baseline Oswestry score of 40% (20/50).
8. Appropriate candidate for treatment using posterior surgical approach.
Exclusion Criteria:
1. More than two vertebral levels requiring surgical decompression.
2. Prior surgical procedure resulting in translatory instability of the lumbar spine.
3. More than one surgical procedure at any combination of lumbar levels.
4. Prior fusion, implantation of a total disc replacement, complete laminectomy, or implantation of an interspinous process device at any lumbar level.
5. Radiographically compromised vertebral body at any lumbar level caused by current or past trauma or tumor.
6. Severe facet hypertrophy requiring extensive bone removal which would cause instability.
7. Isthmic spondylolisthesis or spondylolysis (pars fracture).
8. Degenerative lumbar scoliosis (Cobb angle >25°).
9. Lumbar disc herniation requiring surgical intervention.
10. S.C.O.R.E. ≤6 suggestion of osteopenia or osteoporosis risk confirmed by DEXA T-score equal to or worse than -1.0.
11. Back or leg pain of unknown etiology.
12. Axial back pain only, with no leg, buttock or groin pain.
13. Morbid obesity as defined by BMI >40.
14. Pregnant or interested in becoming pregnant in the next three years.
15. Known allergy to titanium, titanium alloys or MR contrast agents.
16. Active or chronic infection - systemic or local.
17. Chronic use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. steroids), not including Medrol DosePak.
18. History of significant peripheral neuropathy.
19. Significant peripheral vascular disease.
20. Unremitting back pain in any position.
21. Uncontrolled diabetes.
22. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease.
23. Cauda equina syndrome.
24. Fixed and complete motor, sensory, or reflex deficit.
25. Rheumatoid arthritis or other autoimmune disease.
26. History of AIDS, HIV or active Hepatitis.
27. History of invasive malignancy (except non-melanoma skin cancer) within at least five years.
28. History of substance abuse.
29. Current involvement in a study of another investigational product for similar purpose.
30. Currently seeking or receiving workman's compensation.

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