Biological Allograft Chain Tissue Implant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vertebral Body Compression Fracture(s)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Allograft Tissue

Allograft tissue product for patients with painful vertebral compression fractures

Group Type OTHER

Vertebral Body Augmentation

Intervention Type PROCEDURE

Use allograft tissue in patients with one or two level, thoracic or lumbar T6-L5, vertebral compression fractures.

Manual Surgical Instruments

Intervention Type DEVICE

Lenoss Medical manual surgical access and cavity creation instruments will be used when implanting the allograft tissue.

Interventions

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Vertebral Body Augmentation

Use allograft tissue in patients with one or two level, thoracic or lumbar T6-L5, vertebral compression fractures.

Intervention Type PROCEDURE

Manual Surgical Instruments

Lenoss Medical manual surgical access and cavity creation instruments will be used when implanting the allograft tissue.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No