Study to Investigate the Performance of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease

• Sponsor: DePuy International (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00700739
• Collaborator: (none)
• Enrollment: 60
• Locations: 8
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the performance of the Discover cervical Artificial disc in the treatment of degenerative disc disease in one level of the cervical spine.

Condition or Disease	Intervention/Treatment	Phase
Cervical Degenerative Disc Disease	Device: DISCOVER™ Artificial Cervical Disc; Device: ACDF	Phase 4

Detailed Description

The protocol underwent 3 amendments, the last of which (02APR2009) changed the study design from a randomized to a non-randomized and non-comparative clinical trial. All of the subjects were enrolled under the randomized design with the exception of the last subject. This study is not applicable per FDAA Title VIII, Section 801 due to the final trial design. However, results are submitted to clinicaltrials.gov due to the majority of study data being collected under a randomized (FDAA Title VIII, Section 801 applicable) trial design

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Centre, Prospective, Randomized, Post Marketing Surveillance Study Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Cervical Degenerative Disc Disease
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Anterior Cervical Discectomy and Fusion (ACDF) Anterior Cervical Discectomy and Fusion with Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft	Device: ACDF; Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft
Active Comparator: Cervical Total Disc Replacement DISCOVER™ Artificial Cervical Disc	Device: DISCOVER™ Artificial Cervical Disc; DISCOVER™ Artificial Cervical Disc

Outcome Measures

Primary Outcome Measures

1. Overall Patient Success [12 months]

   Overall success was a composite endpoint determined by the following clinical outcome measures: 1. Neck Disability Index ≥ 15-point improvement from baseline to 12 months post-operative, 2. No new clinically significant permanent abnormalities in neurological function (i.e. motor strength, nerve root tension signs, sensory and reflex signs) from baseline to 12 months post-operative, 3. No subsequent secondary surgical interventions (SSI) at the index level, and 4. No device-related serious events (dSAE) from intra-operative through 12-months post-operative. Please note that these time periods were intended to be from baseline to 24 months post-operative, but since the study was terminated early the 12 month time periods were utilized.

Secondary Outcome Measures

1. Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months [12 months]

   The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their neck.

2. Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months. [12 Months]

   The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left arm.

3. Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months. [12 Months]

   The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0= 0 cm) listed on the left and 'Very severe pain' (score of 100= 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right arm.

4. Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months. [12 Months]

   The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right shoulder.

5. Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months. [12 Months]

   The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left shoulder.

6. Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months [12 months]

   The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)

7. Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months [12 months]

   The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)

8. Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months [12 months]

   The neck disability index (NDI) is a validated, disease specific, self-administrated questionnaire for assessing pain intensity and function in patients with neck pain on a scale from 0 to 100. A lower score is a better result (i.e. less severe pain and/or better function). The proportion of patients with an improved score (lower) of 15 points or more was the analysis variable.

9. Work Status Assessed at 12 Months [12 months]

   The proportion of subjects with unrestricted work status (compared to subjects not working or with restricted work status) is reported at the 12 month follow-up interval.

10. Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months [6 months]

    Sagittal Angulation is a measure of the angle formed between the inferior endplate of the C2 vertebrae and the corresponding inferior endplate of vertebrae C7 of the spine, measured in degrees, from a side (sagittal) view.

11. Adjacent Level Degeneration Measured Radiographically at 24 Months [24 months]

    Adjacent Level Degeneration is evaluated using a point system that assigns numerical scores to severity of Height Loss, Anterior Osteophytes, and Endplate Sclerosis; and then grades into one of the following five categories: None, Mild, Moderate, Severe, or NA.

12. Maintenance of Disc Height Measured Radiographically at 6 Months [6 months]

    Maintenance of disc height is measured at the index and adjacent levels to determine the effect of the treatment on restoration or maintenance of the disc height. Initial post-operative disc height is compared with subsequent post-operative visits (i.e. 6 months) to evaluate the maintenance of disc height. The height is measured in millimeters (mm).

13. Foraminal Height Measured Radiographically at 24 Months [24 months]

    Foraminal height is the maximum vertical distance, measured in millimeters (mm), between the inferior surface of the superior pedicle and superior surface of the inferior pedicle. These measurements are obtained via magnetic resonance imaging (MRI).

14. Cervical Range of Motion Measured Radiographically at 6 Months [6 months]

    Cervical range of motion measures the angle, in degrees, between the inferior endplate of C2 to the inferior endplate of C7 on flexion-extension radiographs.

15. Device Related Adverse Events [Intra-operatively to 24 months post-operative]

    The proportion of subjects with device related adverse events as reported throughout the duration of the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female subjects, aged between 18 and 65 years inclusive.

• Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

• Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

• Objective evidence of cervical disc disease in one vertebral level between C3-C7 defined as one or more of the following:

• Shoulder and/or arm pain in a radicular distribution resulting from herniated disc or bony osteophytes (Consistent w diagnostic imaging including Axial CT, CT Myelogram, MRI and/or plain films)

• Subjects with myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement

• Unresponsive to documented non-surgical management for ≥ 6 weeks and/or presents with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management (e.g., physical therapy, medication therapy, corticosteroid injections, etc.)

• Minimum Neck Disability Index score of ≥30 % (15/50 points)

Exclusion Criteria:

• Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.

• Subjects who are pregnant, lactating or wishes to become pregnant within the duration of the study.

• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

• Subjects who have participated in a clinical investigation with an investigational product in the last 30 days.

• Subjects who are currently involved in any injury litigation claims.

• Subjects with significant degeneration at more than one cervical level (e.g. DISH, ankylosing spondylitis, congenital abnormality, rheumatoid arthritis)

• Subjects who have had any prior surgery at the level to be treated (subjects with a prior Laminotomy at the level to be treated may be included in the study)

• Subjects who have marked cervical instability on lateral or flexion/extension x-rays defined as translation ≥3mm and/or ≥11 degrees of rotational difference to either adjacent level

• Subjects who have presence of systemic infection or infection at the site of surgery

• Subjects who have been diagnosed with malignancy

• Subjects who have been diagnosed with a condition or require postoperative medication(s) that may interfere with bony/soft tissue healing

• Subjects who have been diagnosed with Osteoporosis, Osteopenia, other metabolic bone disease or endocrine disorder known to affect osteogenesis.

• Subjects with pre-existing neurological abnormalities other than deficits produced from the spinal lesion (e.g., MS, Parkinson's, CVA, diabetic neuropathy, peripheral neuropathy).

• Subjects with morbid obesity defined as a BMI of ≥40, or more than 100 lbs (45.4kg) over ideal weight.

• Subjects with any known allergy to titanium metal, polyethylene, metal alloy or carbon fibre reinforced polymer

• Subjects who have had prior fusion surgery at any level(s) (C1-T1)

• Subjects with kyphosis >-15 degrees evaluated using the Cobb angle measurement

• Subjects with Significant cervical degenerative disease characterized by bridging anterior osteophytes, significant loss of disc space height (3mm or less), sclerotic facets, large posterior osteophytes, autofusion of other cervical levels, and degenerative retrolisthesis. Spinal diseases such as DISH, ankylosing spondylitis, congenital abnormality, and rheumatoid arthritis, should also be excluded

• Subjects undergoing treatment with a bone growth stimulator, which cannot be discontinued prior to enrollment in the study.

• Significant kyphotic deformity or significant reversal of lordosis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westmead Private Hospital	Sydney	New South Wales	Australia
2	Calvary Hospital	Tasmania		Australia
3	Klinikum Neustadt	Neustadt	Holstein	Germany
4	Divisione di Neurochirurgia	Rome		Italy
5	Island Hospital	Penang		Malaysia
6	Elisabeth Ziekenhuis	Tilburg		Netherlands
7	La Paz Hospital	Madrid		Spain
8	Hope Hospital	Manchester	Lancashire	United Kingdom

Sponsors and Collaborators

• DePuy International

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DePuy International
• ClinicalTrials.gov Identifier: NCT00700739
• Other Study ID Numbers: CT 05/25
• First Posted: Jun 19, 2008
• Last Update Posted: Sep 21, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by DePuy International: Cervical; Disc; Arthroplasty; Spinal
• Additional relevant MeSH terms: Spinal Diseases; Intervertebral Disc Degeneration

Study Results

Participant Flow

Recruitment Details	5 sites enrolled 60 subjects who were randomized into two treatment groups. Site 12 (17 subjects total) transferred into the Discover IDE study. Site 04 (5 subjects total) did not submit data, which was limited, due to EDC technical difficulties at the site. Therefore 38 subjects are reported in this study.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Period Title: Overall Study
STARTED	22	16
COMPLETED	18	12
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Cervical Total Disc Replacement	ACDF	Total
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)	Total of all reporting groups
Overall Participants	22	16	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.3 (8.87)	47.5 (8.17)	46.2 (8.65)
Sex: Female, Male (Count of Participants)
Female	11 50%	11 68.8%	22 57.9%
Male	11 50%	5 31.3%	16 42.1%
Region of Enrollment (participants) [Number]
Spain	2 9.1%	1 6.3%	3 7.9%
Germany	0 0%	1 6.3%	1 2.6%
United Kingdom	20 90.9%	14 87.5%	34 89.5%

Outcome Measures

1. Primary Outcome

Title	Overall Patient Success
Description	Overall success was a composite endpoint determined by the following clinical outcome measures: 1. Neck Disability Index ≥ 15-point improvement from baseline to 12 months post-operative, 2. No new clinically significant permanent abnormalities in neurological function (i.e. motor strength, nerve root tension signs, sensory and reflex signs) from baseline to 12 months post-operative, 3. No subsequent secondary surgical interventions (SSI) at the index level, and 4. No device-related serious events (dSAE) from intra-operative through 12-months post-operative. Please note that these time periods were intended to be from baseline to 24 months post-operative, but since the study was terminated early the 12 month time periods were utilized.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Overall Patient Success is composed of several outcome measures, some of which require a valid pre-operative and 12-month post-operative score. Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for the Overall Patient Success calculation.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	18	11
Number [Percentage of subjects]	33.33	90.91

2. Secondary Outcome

Title	Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months
Description	The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their neck.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	18	11
Mean (Standard Deviation) [units on a scale]	-16.6 (34.2)	-52.1 (22.86)

3. Secondary Outcome

Title	Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months.
Description	The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left arm.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	18	11
Mean (Standard Deviation) [units on a scale]	-15.9 (25.7)	-46.6 (43.5)

4. Secondary Outcome

Title	Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months.
Description	The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0= 0 cm) listed on the left and 'Very severe pain' (score of 100= 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right arm.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	18	11
Mean (Standard Deviation) [units on a scale]	-18.4 (32.8)	-20.5 (25.8)

5. Secondary Outcome

Title	Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months.
Description	The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right shoulder.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	18	11
Mean (Standard Deviation) [units on a scale]	-15.7 (35.4)	-22.4 (32.7)

6. Secondary Outcome

Title	Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months.
Description	The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left shoulder.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Due to withdrawals and incomplete or unavailable assessments, 17 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	17	11
Mean (Standard Deviation) [units on a scale]	-17.1 (28.9)	-49.8 (36.5)

7. Secondary Outcome

Title	Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months
Description	The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	16	10
Mean (Standard Deviation) [units on a scale]	4.1 (13.2)	15.1 (14)

8. Secondary Outcome

Title	Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months
Description	The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	16	10
Mean (Standard Deviation) [units on a scale]	8.1 (11.7)	17.7 (9.2)

9. Secondary Outcome

Title	Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months
Description	The neck disability index (NDI) is a validated, disease specific, self-administrated questionnaire for assessing pain intensity and function in patients with neck pain on a scale from 0 to 100. A lower score is a better result (i.e. less severe pain and/or better function). The proportion of patients with an improved score (lower) of 15 points or more was the analysis variable.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	18	11
Number [Percentage of Subjects]	33.33	90.91

10. Secondary Outcome

Title	Work Status Assessed at 12 Months
Description	The proportion of subjects with unrestricted work status (compared to subjects not working or with restricted work status) is reported at the 12 month follow-up interval.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 12 subjects in the ACDF treatment groups were available for this outcome.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	18	12
Number [Percentage of Subjects]	38.89	50.00

11. Secondary Outcome

Title	Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months
Description	Sagittal Angulation is a measure of the angle formed between the inferior endplate of the C2 vertebrae and the corresponding inferior endplate of vertebrae C7 of the spine, measured in degrees, from a side (sagittal) view.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Only 2 subjects in the Cervical Total Disc Replacement (cTDR) and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	2	1
Mean (Standard Deviation) [degrees]	9.6 (10)	-1.5 (NA)

12. Secondary Outcome

Title	Adjacent Level Degeneration Measured Radiographically at 24 Months
Description	Adjacent Level Degeneration is evaluated using a point system that assigns numerical scores to severity of Height Loss, Anterior Osteophytes, and Endplate Sclerosis; and then grades into one of the following five categories: None, Mild, Moderate, Severe, or NA.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Study was terminated prior to 24 months therefore there are no results for this endpoint.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	0	0

13. Secondary Outcome

Title	Maintenance of Disc Height Measured Radiographically at 6 Months
Description	Maintenance of disc height is measured at the index and adjacent levels to determine the effect of the treatment on restoration or maintenance of the disc height. Initial post-operative disc height is compared with subsequent post-operative visits (i.e. 6 months) to evaluate the maintenance of disc height. The height is measured in millimeters (mm).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Only 2 subjects in the cTDR and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	2	1
Mean (Standard Deviation) [mm]	4.7 (0.57)	5.1 (NA)

14. Secondary Outcome

Title	Foraminal Height Measured Radiographically at 24 Months
Description	Foraminal height is the maximum vertical distance, measured in millimeters (mm), between the inferior surface of the superior pedicle and superior surface of the inferior pedicle. These measurements are obtained via magnetic resonance imaging (MRI).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The study was terminated prior to 24 months therefore there are no results for this endpoint.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	0	0

15. Secondary Outcome

Title	Cervical Range of Motion Measured Radiographically at 6 Months
Description	Cervical range of motion measures the angle, in degrees, between the inferior endplate of C2 to the inferior endplate of C7 on flexion-extension radiographs.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Only 2 subjects in the cTDR and 2 subjects in the ACDF treatment groups were available for this outcome measure.

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	2	2
Mean (Standard Deviation) [degrees]	53.9 (16.4)	55.2 (25.5)

16. Secondary Outcome

Title	Device Related Adverse Events
Description	The proportion of subjects with device related adverse events as reported throughout the duration of the study.
Time Frame	Intra-operatively to 24 months post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervical Total Disc Replacement	ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc	Anterior Cervical Discectomy and Fusion (ACDF)
Measure Participants	22	16
Number [Percentage of subjects]	13.64	0.00

Adverse Events

Time Frame	Adverse Events were collected from the intra-operatively to 24 months post-operative timepoint (the patient with the longest follow-up for potential AE reporting was 24 months).
Arm/Group Title	Cervical Total Disc Replacement		ACDF
Arm/Group Description	DISCOVER™ Artificial Cervical Disc		Anterior Cervical Discectomy and Fusion (ACDF)
All Cause Mortality
	Cervical Total Disc Replacement		ACDF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cervical Total Disc Replacement		ACDF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/22 (13.6%)		1/16 (6.3%)
Infections and infestations
Lower Respiratory Tract Infections	0/22 (0%)	0	1/16 (6.3%)	1
Musculoskeletal and connective tissue disorders
Neck Pain	3/22 (13.6%)	3	0/16 (0%)	0
Pain in Extremity	1/22 (4.5%)	1	0/16 (0%)	0
Other (Not Including Serious) Adverse Events
	Cervical Total Disc Replacement		ACDF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/22 (40.9%)		6/16 (37.5%)
Gastrointestinal disorders
Dysphagia	1/22 (4.5%)	1	1/16 (6.3%)	1
Faecal Incontinence	0/22 (0%)	0	1/16 (6.3%)	1
Injury, poisoning and procedural complications
Fall	0/22 (0%)	0	1/16 (6.3%)	1
Musculoskeletal and connective tissue disorders
Back Pain	0/22 (0%)	0	1/16 (6.3%)	1
Neck Pain	6/22 (27.3%)	6	2/16 (12.5%)	2
Pain in Extremity	1/22 (4.5%)	1	1/16 (6.3%)	1
Nervous system disorders
Horner's Syndrome	0/22 (0%)	0	1/16 (6.3%)	1
Paraesthesia	1/22 (4.5%)	1	1/16 (6.3%)	1

Limitations/Caveats

Study was terminated early therefore the latest clinical data available is at the 12 month post-operative timepoint and the latest radiographic data available is at the 6 month post-operative timepoint.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Clinical Investigators may freely present or publish results of the Clinical Investigation in a manner which fairly sets forth the conclusions reached by the Clinical Investigators, but only after DePuy has been given the opportunity of reviewing the proposed presentation or publication at least 30 days prior to the intended submission, presentation, or publication date.