Trial Outcomes & Findings for MaxAn Post Market Surveillance Validation (NCT NCT01343693)

Last Updated: 2020-01-06

Results Overview

Qualitatively assessed by an independent Radiologist using lateral radiographs Grade 0 - None Grade 1 - Mild (if the ossification extended across \<50% of the disc space) Grade 2 - Moderate (if the ossification extended across ≥ 50% of the disc space) Grade 3 - Severe (if there is complete bridging of the adjacent disc space)

Recruitment status

COMPLETED

Target enrollment

119 participants

Primary outcome timeframe

24 Months

Results posted on

2020-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	ACDF With MaxAn Plate Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.
Overall Study STARTED	119
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	ACDF With MaxAn Plate Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.
Overall Study Lost to Follow-up	9

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACDF With MaxAn Plate n=119 Participants Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.
Age, Continuous	54.3 years n=119 Participants
Sex: Female, Male Female	66 Participants n=119 Participants
Sex: Female, Male Male	53 Participants n=119 Participants
Region of Enrollment United States	119 participants n=119 Participants
BMI (kg/m^2)	29.8 kg/m^2 STANDARD_DEVIATION 5.5 • n=119 Participants
Employment Status Currently Working	50 Participants n=119 Participants
Employment Status Disabled/Retired Due to Ill Health	28 Participants n=119 Participants
Employment Status Retired	23 Participants n=119 Participants
Employment Status Unemployed	7 Participants n=119 Participants
Employment Status Workers Compensation	3 Participants n=119 Participants
Employment Status Not Reported	8 Participants n=119 Participants
Tobacco Use Current	37 Participants n=119 Participants
Tobacco Use Past	30 Participants n=119 Participants
Tobacco Use Never	52 Participants n=119 Participants
Previous Cervical Spine Surgery Yes	24 Participants n=119 Participants
Previous Cervical Spine Surgery No	95 Participants n=119 Participants
Number of Operated Levels One vertebral level	27 Participants n=119 Participants
Number of Operated Levels Two vertebral levels	69 Participants n=119 Participants
Number of Operated Levels Three vertebral levels	23 Participants n=119 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: Ten of the 110 patients with 24 month follow up were not evaluated for this endpoint. Eight had missing radiographs and 2 had unevaluable radiographs.

Outcome measures

Outcome measures
Measure	ACDF With MaxAn Plate n=110 Participants Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.
Number of Participants With Differing Severity of Adjacent Level Ossification Grade 0	36 Participants
Number of Participants With Differing Severity of Adjacent Level Ossification Grade 1	38 Participants
Number of Participants With Differing Severity of Adjacent Level Ossification Grade 2	16 Participants
Number of Participants With Differing Severity of Adjacent Level Ossification Grade 3	10 Participants
Number of Participants With Differing Severity of Adjacent Level Ossification Unable to Assess	2 Participants
Number of Participants With Differing Severity of Adjacent Level Ossification Missing Radiographs	8 Participants

SECONDARY outcome

Timeframe: 24 Months

The Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain', with the points summed to a total score. The test can be interpretated as a raw score, with a minimum score of 0 and a maximum score of 50. A higher score indicates more patient-rated disability. To use the NDI for patient decisions, a clinically important change was calculated as 5 points.

Outcome measures

Outcome measures
Measure	ACDF With MaxAn Plate n=110 Participants Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.
Change in Neck Disability Index (NDI)	22.0 score on a scale Standard Deviation 20.0

Adverse Events

ACDF With MaxAn Plate

Serious events: 14 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ACDF With MaxAn Plate n=119 participants at risk Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.
Musculoskeletal and connective tissue disorders Neck pain	11.8% 14/119 • Number of events 16 • 24 Months All adverse 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 were recorded as part of the study.

Other adverse events

Other adverse events
Measure	ACDF With MaxAn Plate n=119 participants at risk Any subject with DDD, tumor, deformity ot trauma to the cervical spine in which the investigator determines the subject will require an ACDF using the MaxAn Plate.
Musculoskeletal and connective tissue disorders Musculoskeletal Other - Pseudoarthrosis	16.8% 20/119 • Number of events 20 • 24 Months All adverse 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 were recorded as part of the study.
Musculoskeletal and connective tissue disorders Musculoskeletal other - Degenerative disc disease	12.6% 15/119 • Number of events 15 • 24 Months All adverse 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 were recorded as part of the study.
Musculoskeletal and connective tissue disorders Neck Pain	11.8% 14/119 • Number of events 14 • 24 Months All adverse 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 were recorded as part of the study.
Nervous system disorders Paresthesia	6.7% 8/119 • Number of events 8 • 24 Months All adverse 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 were recorded as part of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Radiculitis	10.9% 13/119 • Number of events 13 • 24 Months All adverse 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 were recorded as part of the study.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 6/119 • Number of events 6 • 24 Months All adverse 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 were recorded as part of the study.
Gastrointestinal disorders Dysphagia	7.6% 9/119 • Number of events 9 • 24 Months All adverse 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 were recorded as part of the study.
Nervous system disorders Headache	5.0% 6/119 • Number of events 6 • 24 Months All adverse 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 were recorded as part of the study.
Injury, poisoning and procedural complications Wound complication	3.4% 4/119 • Number of events 4 • 24 Months All adverse 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 were recorded as part of the study.
Injury, poisoning and procedural complications Procedural complication, other	1.7% 2/119 • Number of events 2 • 24 Months All adverse 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 were recorded as part of the study.
Injury, poisoning and procedural complications Procedural complication other	0.84% 1/119 • Number of events 1 • 24 Months All adverse 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 were recorded as part of the study.
Musculoskeletal and connective tissue disorders Radiculitis	5.9% 7/119 • Number of events 7 • 24 Months All adverse 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 were recorded as part of the study.
Musculoskeletal and connective tissue disorders Musculoskeletal other	2.5% 3/119 • Number of events 3 • 24 Months All adverse 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 were recorded as part of the study.
Gastrointestinal disorders Abdominal pain	1.7% 2/119 • Number of events 2 • 24 Months All adverse 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 were recorded as part of the study.
Musculoskeletal and connective tissue disorders Back pain	1.7% 2/119 • Number of events 2 • 24 Months All adverse 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 were recorded as part of the study.

Additional Information

Zimmer Biomet Spine 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