UnknownNot Applicable

Biological Allograft Chain Tissue Implant

United States26 participantsStarted 2019-06-10

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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;

What they're measuring

Evaluate fracture stability assessed via subject- reported pain over time

Timeframe: 12 months

Trial details

NCT IDNCT04064710

SponsorLenoss Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-01

Contact for this trial

Dom Messerli

484-988-0477 dom.messerli@lenoss.com

View on ClinicalTrials.gov More Vertebral Body Compression Fracture(s) trials