Clinical trial NCT04064710: Biological Allograft Chain Tissue Implant
Official title: The Biological Allograft Chain Tissue Implant & Associated Manual Surgical Instrumentation: A Prospective, Post-Market Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vertebral Body Compression Fracture(s)
Lead sponsor: Lenoss Medical
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2019-08-22
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Vertebral compression fractures can be associated with instability and severe, persistent pain and limitation of activities. This post market study is being conducted to assess fracture stability over time.

Eligibility criteria: Inclusion Criteria:

1. Skeletally mature adult ≥ 50 years of age at the time of surgery;
2. Currently in an independent living environment;
3. 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;
4. 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;
5. VAS back pain score ≥ 70 mm on a 100 mm scale;
6. Has central pain over the spinous process upon palpation at the planned vertebral index level;
7. Has failed prior non-surgical medical management (i.e. - physical therapy, narcotic and/or non-narcotic medication)
8. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
9. 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.

Exclusion Criteria:

1. More than two levels with a vertebral compression fracture;
2. Previous treated or untreated vertebral compression fracture at the to be treated level(s);
3. Uncorrectable coagulopathy;
4. Previous instrumented spinal surgery;
5. Significant vertebral collapse defined as \> 70% of original vertebral height, or a burst, or pedicle fracture;
6. Degenerative scoliosis, defined as Cobb angle \> 20° at any level;
7. Pre-existing neurological deficit or radicular pain that is not well defined or unstable;
8. Disabling back pain secondary to causes other than acute fracture;
9. Inability to walk or stand prior to sustaining the vertebral compression fracture;
10. Active systemic or local infection;
11. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
12. Morbid obesity defined as a body mass index \> 40 kg/m2;
13. 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;
14. Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
15. Currently involved in study of another investigational product that may affect outcome;
16. History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
17. Pregnant or planning to become pregnant during the study period;
18. Involved in active spinal litigation;
19. Involved in a workers compensation case;
20. Prisoner or ward of the state;
21. Unable to undergo a MRI/CT procedure.

Primary outcomes:
measure: Evaluate fracture stability assessed via subject- reported pain over time
timeFrame: 12 months
Secondary outcomes:
measure: Measure of Physical Disability Assessed via the Roland Morris Disability Questionnaire
timeFrame: 12 months
measure: Measurement of Quality of Life Assessed via the EuroQol Health Outcome Instrument (EQ-5D-3L)
timeFrame: 12 months
measure: Measurement of Activities of Daily Living Assessed via the Modified Tegner Activity Level Scale
timeFrame: 12 months
measure: Frequency of Implant Related Complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Denver | Anschutz Medical Campus
state: Colorado
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Edmond
country: United States
facility: Clinical Investigations LLC
state: Oklahoma
Study officials:
References: