Biological Allograft Chain Tissue Implant
Status unconfirmed · Not applicable
Conditions studied: Vertebral Body Compression Fracture(s)
In brief
A prospective, multi-center study evaluating allograft tissue as a bone void filler when implanted with Lenoss Medical manual surgical instrumentation in patients with painful vertebral compression fractures.
Key facts
- Study ID
- NCT04064710
- Run by
- Lenoss Medical
- People needed
- 26
- Starts
- 2019-06-10
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2021-05-14
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Skeletally mature adult ≥ 50 years of age at the time of surgery;
- Currently in an independent living environment;
- One- or two- level, acute (within six weeks of injury), thoracic or lumbar (T6-L5) vertebral body compression fracture(s) with evidence of marrow edema by MRI/CT;
- Adequate vertebral body height and geometry for insertion of the access instruments, as determined by the investigator and suitable candidate for standard kyphoplasty or vertebroplasty procedure;
- VAS back pain score ≥ 70 mm on a 100 mm scale;
- Has central pain over the spinous process upon palpation at the planned vertebral index level;
- Has failed prior non-surgical medical management (i.e. - physical therapy, narcotic and/or non-narcotic medication)
- Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
- Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
You may not qualify if…
- More than two levels with a vertebral compression fracture;
- Previous treated or untreated vertebral compression fracture at the to be treated level(s);
- Uncorrectable coagulopathy;
- Previous instrumented spinal surgery;
- Significant vertebral collapse defined as > 70% of original vertebral height, or a burst, or pedicle fracture;
- Degenerative scoliosis, defined as Cobb angle > 20° at any level;
- Pre-existing neurological deficit or radicular pain that is not well defined or unstable;
- Disabling back pain secondary to causes other than acute fracture;
- Inability to walk or stand prior to sustaining the vertebral compression fracture;
- Active systemic or local infection;
- Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
- Morbid obesity defined as a body mass index > 40 kg/m2;
- Active malignancy. A patient with a history of any invasive malignancy (except nonmelanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
- Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
- Currently involved in study of another investigational product that may affect outcome;
- History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
- Pregnant or planning to become pregnant during the study period;
- Involved in active spinal litigation;
- Involved in a workers compensation case;
- Prisoner or ward of the state;
- Unable to undergo a MRI/CT procedure.
Where it is running
- University of Colorado Denver | Anschutz Medical Campus — Denver, Colorado, United States (enrolling)
- North Shore University Hospital — Manhasset, New York, United States (enrolling)
- Mount Sinai — New York, New York, United States (enrolling)
- Montefiore Medical Center — The Bronx, New York, United States (enrolling)
- Clinical Investigations LLC — Edmond, Oklahoma, United States
Full record on ClinicalTrials.gov
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