Trial Outcomes & Findings for Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn) (NCT NCT02182843)

Last Updated: 2019-03-15

Results Overview

Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each of the 10 items is scored from 0 - 5, with a maximum score of 50. The obtained score is multiplied by 2 to produce a percentage score. A higher score indicates more patient-rated disability (0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation). The minimal clinically important difference or change (MCID / MCIC) is described as the smallest difference or change that patients perceive as beneficial. In patients with cervical radiculopathy the MCID is 7 points of change ( 14%). In order to demonstrate improvement in status, the NDI would need to be reduced by at least 14%.

Recruitment status

COMPLETED

Study phase

Target enrollment

81 participants

Primary outcome timeframe

12 months after device implantation

Results posted on

2019-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Cellentra VCBM Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
Overall Study STARTED	81
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Cellentra VCBM Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
Overall Study Withdrawal by Subject	7
Overall Study Lost to Follow-up	2
Overall Study Adverse Event	1

Baseline Characteristics

Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cellentra VCBM n=81 Participants Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
Age, Continuous	53.9 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	81 participants n=5 Participants
BMI (kg/m^2)	30.4 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants
Tobacco Use Current	31 Participants n=5 Participants
Tobacco Use Past	12 Participants n=5 Participants
Tobacco Use Never	38 Participants n=5 Participants
Previous Spine Surgery	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after device implantation

Outcome measures

Outcome measures
Measure	Cellentra VCBM n=81 Participants Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
Change in NDI From Baseline Baseline	52.1 score on a scale Standard Deviation 19.1
Change in NDI From Baseline 12 months	28.5 score on a scale Standard Deviation 24.3
Change in NDI From Baseline Mean Change in NDI	24.0 score on a scale Standard Deviation 21.9

SECONDARY outcome

Timeframe: 24 Months

Population: 71/81 of originally enrolled participants had radiographs available for analysis at 24 months

Radiographic fusion was assessed at each operated level using the Bridwell fusion grading system: * Grade I (definite) - Fused with remodeling and trabeculae * Grade II (probable) - Graft intact, not fully remodeled and incorporated through, no lucencies * Grade III (probably not) - Graft intact, but definite lucency at the top or bottom of the graft * Grade IV (no) - Definitely not fused, with resorption of bone graft or collapse. Radiographic success was defined as grade 1 or 2 fusion at every operated level at 24 months

Outcome measures

Outcome measures
Measure	Cellentra VCBM n=71 Participants Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
Number of Participants With Radiographic Success at 24 Months	35 Participants

Adverse Events

Cellentra VCBM

Serious events: 8 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cellentra VCBM n=81 participants at risk Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
Musculoskeletal and connective tissue disorders Lumbar Stenosis	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Injury, poisoning and procedural complications Overdose	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Nervous system disorders Cerbrovascular ischemia	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Nervous system disorders Radiculitis	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Musculoskeletal and connective tissue disorders Arthritis	2.5% 2/81 • Number of events 2 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Infections and infestations Soft tissue infection	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.

Other adverse events

Other adverse events
Measure	Cellentra VCBM n=81 participants at risk Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
Immune system disorders Autoimmune disorder	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Musculoskeletal and connective tissue disorders Back pain	2.5% 2/81 • Number of events 2 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Nervous system disorders Cerebrospinal fluid leak	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Musculoskeletal and connective tissue disorders Chest wall pain	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Musculoskeletal and connective tissue disorders Delayed union	8.6% 7/81 • Number of events 7 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Nervous system disorders Dural defect	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Gastrointestinal disorders Dysphagia	4.9% 4/81 • Number of events 4 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.5% 2/81 • Number of events 2 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Injury, poisoning and procedural complications Fall	7.4% 6/81 • Number of events 6 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Nervous system disorders Headache	2.5% 2/81 • Number of events 2 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Hepatobiliary disorders Hepatic pain	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Metabolism and nutrition disorders Hyperglycemia	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Musculoskeletal and connective tissue disorders Myalgia	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Musculoskeletal and connective tissue disorders Neck pain	6.2% 5/81 • Number of events 5 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
General disorders Pain	2.5% 2/81 • Number of events 2 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Nervous system disorders Paresthesia	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Nervous system disorders Radiculitis	2.5% 2/81 • Number of events 2 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Nervous system disorders Syncope	1.2% 1/81 • Number of events 1 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.
Infections and infestations Wound infection	2.5% 2/81 • Number of events 2 • Adverse events were collected from the time of surgery through last follow up at 24 months. All clinical events, including both observed or volunteered problems, complaints, symptoms, physical signs or disease which either occur during the study, having been absent at baseline, or, if present at baseline, appear to worsen during the clinical outcomes collection study are to be recorded as complications in the subject's medical record and on the appropriate case report form.

Additional Information

Clinical Affairs

Zimmer Biomet Spine

Phone: 303-501-8571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place