PCM Cervical Disc System

• Sponsor: NuVasive (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00578812
• Collaborator: (none)
• Enrollment: 494
• Locations: 23
• Arms: 2
• Duration (Months): 115
• Patients Per Site: 21.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.

Condition or Disease	Intervention/Treatment	Phase
Radiculopathy; Myelopathy	Device: Anterior Cervical Discectomy and Fusion (ACDF); Device: PCM Cervical Disc	Phase 3

Detailed Description

The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years comparatively between the PCM Cervical Disc and anterior cervical discectomy and fusion (ACDF) with allograft and plate. Patients with adjacent or non-adjacent prior fusion were allowed. A total of 416 patients with a degenerated cervical disc at one level from C3-C4 to C7-T1 were enrolled in the clinical trial and 403 were treated. Patients were randomly assigned to be treated either with the PCM Cervical Disc or ACDF.

Patients were evaluated before surgery, during the operation, immediately after surgery, and then at 6 weeks, 3 months, 6 months, 12 months and 24 months, and yearly after surgery. The patients were recommended to have a physical therapy program for non-impact exercises and active range of motion exercises after surgery. Patients were also instructed to avoid repetitive cervical flexion and extension bending and lateral bending and rotation for 6 weeks following surgery.

The safety of the PCM Cervical Disc was assessed by comparing the adverse events, any additional surgical procedures, and the neurological outcomes to those in the ACDF control group. The effectiveness of the PCM Cervical Disc was assessed by evaluating patients' pain and function outcomes using a standard questionnaire, the Neck Disability Index (NDI), the severity of neck and arm pain based on a Visual Analog Scale (VAS) assessment, quality of life using a standard questionnaire, the Short Form-36 (SF-36), as well as a patient satisfaction questionnaire compared to the ACDF control group. In addition, the patients were evaluated using radiographic evaluations, including spinal range of motion, spinal disc height, device displacement or migration, spinal fusion status, and heterotopic ossification (abnormal bone formation).

The primary endpoint of the IDE trial was a composite measure termed "overall success," which was evaluated at 24 months postoperatively, and was defined as at least 20% improvement in neck disability index (NDI) from preoperative score; absence of reoperation, revision, or removal; maintenance or improvement in neurological status; and absence of radiographic or major complications during the 24-month follow-up period.

On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.

Study Design

• Study Type: Interventional
• Actual Enrollment: 494 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Controlled Clinical Investigation Comparing PCM® Cervical Disc Arthroplasty to Anterior Cervical Discectomy and Fusion: 2 Year Results From the US IDE Clinical Trial
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PCM Cervical Disc - Investigational PCM Cervical Disc replacement at one level from C3 to T1	Device: PCM Cervical Disc; PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Active Comparator: ACDF - Control Group Anterior cervical discectomy and fusion (ACDF) at one level from C3 to T1	Device: Anterior Cervical Discectomy and Fusion (ACDF); Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1

Outcome Measures

Primary Outcome Measures

1. Individual Patient Overall Success [24 Months]

   Individual patient overall success defined as ≥20% improvement in Neck Disability Index (NDI) from preoperative score, no device failures requiring revision, reoperation or removal, and the absence of radiographic or major complications during the 24-month follow-up period.

Secondary Outcome Measures

1. Neck Pain Visual Analog Scale [24 Months]

   Improvement of ≥20mm in neck pain at 24 months compared to baseline.

2. Mean Neck Pain Visual Analog Scale [24 Months]

   Mean neck pain at 24 months on a 0-100 mm Visual Analog Scale (lower value is better).

3. Worst Arm Pain Visual Analog Scale [24 Months]

   Improvement of ≥20mm in worst arm pain at 24 months compared to baseline.

4. Mean Worst Arm Pain Visual Analog Scale [24 Months]

   Mean worst arm pain at 24 months on a 0-100mm Visual Analog Scale (lower value is better).

5. Clinically Significant Improvement on Neck Disability Index (NDI) [24 Months]

   Improvement in NDI of ≥20% at 24 months compared to baseline.

6. Clinically Significant Improvement on Neck Disability Index (NDI) [24 Months]

   Improvement in NDI of ≥15-points at 24 months compared to baseline.

7. Mean Neck Disability Index (NDI) [24 Months]

   Mean NDI at 24 months on a 0-100 scale (lower value is better).

8. Clinically Significant Improvement on SF-36 Physical Component Summary (PCS) [24 Months]

   Improvement of ≥15% on SF-36 PCS at 24 months compared to baseline.

9. Mean SF-36 Physical Component Summary (PCS) [24 Months]

   Mean SF-36 PCS at 24 months on a 0-100 scale (lower value is better).

10. Clinically Significant Improvement on SF-36 Mental Component Summary (MCS) [24 Months]

    Improvement of ≥15% on the SF-36 MCS at 24 months compared to baseline.

11. Mean SF-36 Mental Component Summary (MCS) [24 Months]

    Mean SF-36 MCS at 24 months on a 0-100 scale (lower value is better).

12. Dysphagia for Swallowing [24 Months]

    Mean dysphagia for swallowing at 24 months on a 0-100mm Visual Analog Scale (lower value is better).

13. Patient Satisfaction [24 Months]

    Mean Patient Satisfaction at 24 months on a 0-100 Visual Analog Scale (higher value is better).

14. Nurick's Classification of Disability (Myelopathy) [24 Months]

    Maintenance or improvement in Nurick's Classification from baseline to 24 months. Nurick's classification is a six-point scale, graded 0 to 5. A grade of 0 indicates no symptoms at all, while a grade of 5 is a bed or chair-bound patient. A patient "maintained" if their Nurick classification grade remained the same or "improved" if it decreased from baseline to 24 months.

15. Flexion/Extension Range of Motion at the Operative Level [24 Months]

    Mean flexion/extension range of motion at operative level at 24 months. The operative level is defined as the cervical spinal level at which the surgical procedure was performed.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Age 18-65 years;

• Diagnosis of radiculopathy or myelopathy of the cervical spine between C3-4 and C7-T1;

• Symptomatic at only one level from C3-C4 to C7-T1;

• Unresponsive to non-operative treatment for six weeks, or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment;

• Baseline NDI score of ≥30/100;

• Radiographically determined pathology at level to be treated correlating to primary symptoms, including at least one of the following: decreased disc height, degenerative spondylosis on CT or MRI, or disc herniation;

• Appropriate for treatment using an anterior surgical approach, including having no more than one previous anterior surgical approach to the cervical spine;

• Ability and willingness to comply with follow-up regimen; and

• Written informed consent given by subject or subject's legally authorized representative.

Exclusion Criteria:

• Infection at the site of surgery;

• History of, or anticipated treatment for, active systemic infection, including HIV infection or hepatitis C;

• Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomy with less than one-third facetectomy at any level, or (2) a successful single-level anterior cervical fusion;

• More than one immobile vertebral level between C1-T1 from any cause, including but not limited to congenital abnormalities, osteoarthritic "spontaneous" fusions, and prior cervical spinal fusions;

• Previous trauma to the C3-T1 levels resulting in significant bony or disco-ligamentous cervical spine injury;

• Axial neck pain in the absence of other symptoms of radiculopathy or myelopathy justifying the need for surgical intervention;

• Radiographic confirmation of severe facet joint disease or degeneration.

• Osteoporosis:

• Severe diabetes mellitus requiring daily insulin management;

• Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;

• Tumor as source of symptoms;

• Symptomatic DDD or significant cervical spondylosis at two or more levels;

• Known or suspected allergy to cobalt, chromium, molybdenum, titanium, or polyethylene;

• Severe myelopathy to the extent that the patient is wheelchair bound;

• Pregnant (verified in patients of childbearing potential by a negative urine pregnancy test when preadmission testing is obtained), or interested in becoming pregnant during the duration of the study;

• Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis; ankylosing spondylitis);

• Spinal axis disease (thoracic or lumbar) to the extent that surgical consideration is likely anticipated within 6 months after the cervical randomized procedure;

• Other degenerative joint disease (e.g. shoulder, hip, knee) to the extent that surgical consideration is likely anticipated within 6 months after the cervical randomized procedure;

• Previous spine surgery within the 6 months preceding the cervical randomized procedure;

• Current or recent history of substance abuse (drug or alcohol);

• Morbid obesity, defined as body mass index ("BMI") > 40 or more than 100 lbs. over ideal body weight;

• Currently using, or planning to use, bone growth stimulators in the cervical spine;

• Use of any other investigational drug or medical device within the last 30 days prior to surgery

• Currently a prisoner; or

• Currently pursuing personal litigation related to the neck or cervical spine injury; however, involvement in worker's compensation related litigation is not a required exclusion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tower Orthopedics	Beverly Hills	California	United States	90211
2	Spine Group Beverly Hills	Beverly Hills	California	United States	90212
3	Denver Spine	Greenwood Village	Colorado	United States	80111
4	Walter Reed Army Medical Center	Washington, DC	District of Columbia	United States	20307
5	Midwest Orthopedic Associates at Rush	Chicago	Illinois	United States	60612
6	Chicago Back Institute	Chicago	Illinois	United States	60625
7	Goodman Campbell Brain and Spine	Indianapolis	Indiana	United States	46260
8	Towson Orthopedic Associates	Towson	Maryland	United States	21204
9	Wm. Beaumont Hospital	Southfield	Michigan	United States	48034
10	Mayo Clinic	Rochester	Minnesota	United States	55905
11	Columbia Orthopedic Research	Columbia	Missouri	United States	65201
12	Buffalo Spine Surgery	Lockport	New York	United States	14094
13	Institute for Spine Care	Syracuse	New York	United States	13202
14	The Cleveland Clinic	Cleveland	Ohio	United States	44195
15	OrthoNeuro	Westerville	Ohio	United States	43054
16	Neuroscience Specialists	Oklahoma City	Oklahoma	United States	73120
17	The Rothman Institute	Philadelphia	Pennsylvania	United States	19107
18	Neurosurgical Associates of San Antonio	San Antonio	Texas	United States	78229
19	Scott and White Memorial Hospital	Temple	Texas	United States	76508
20	Virginia Brain and Spine	Winchester	Virginia	United States	22601
21	Olympia Othopaedic Associates	Olympia	Washington	United States	98502
22	Madigan Army Medical Center	Tacoma	Washington	United States	98431-1100
23	NeuroSpine Center of Wisconsin	Appleton	Wisconsin	United States	54913

Sponsors and Collaborators

• NuVasive

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NuVasive

Publications

None provided.

• Responsible Party: NuVasive
• ClinicalTrials.gov Identifier: NCT00578812
• Other Study ID Numbers: G040081
• First Posted: Dec 21, 2007
• Last Update Posted: Jul 7, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Radiculopathy; Spinal Cord Diseases

Study Results

Participant Flow

Pre-assignment Detail	Each clinical site could treat up to two (2) non-randomized investigational training patients prior to entering the randomized phase of the clinical trial.

Arm/Group Title	PCM Cervical Disc - Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Period Title: Overall Study
STARTED	224	192
COMPLETED	218	185
NOT COMPLETED	6	7

Baseline Characteristics

Arm/Group Title	PCM Cervical Disc - Investigational	Anterior Cervical Discectomy and Fusion - Control Group	Total
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Total of all reporting groups
Overall Participants	218	185	403
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.3 (9.0)	43.7 (8.3)	44.5 (8.7)
Sex: Female, Male (Count of Participants)
Female	105 48.2%	89 48.1%	194 48.1%
Male	113 51.8%	96 51.9%	209 51.9%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	202 92.7%	170 91.9%	372 92.3%
Black	10 4.6%	7 3.8%	17 4.2%
Asian	0 0%	5 2.7%	5 1.2%
Hispanic	3 1.4%	2 1.1%	5 1.2%
Other	3 1.4%	1 0.5%	4 1%
Region of Enrollment (participants) [Number]
United States	218 100%	185 100%	403 100%

Outcome Measures

1. Primary Outcome

Title	Individual Patient Overall Success
Description	Individual patient overall success defined as ≥20% improvement in Neck Disability Index (NDI) from preoperative score, no device failures requiring revision, reoperation or removal, and the absence of radiographic or major complications during the 24-month follow-up period.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	PCM Cervical Disc-Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	189	151
Number [participants]	142 65.1%	98 53%

2. Secondary Outcome

Title	Neck Pain Visual Analog Scale
Description	Improvement of ≥20mm in neck pain at 24 months compared to baseline.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	PCM Cervical Disc - Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	187	150
Number [participants]	139 63.8%	113 61.1%

3. Secondary Outcome

Title	Mean Neck Pain Visual Analog Scale
Description	Mean neck pain at 24 months on a 0-100 mm Visual Analog Scale (lower value is better).
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	PCM Cervical Disc - Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	187	150
Mean (Standard Deviation) [mm]	26.1 (28.7)	30.4 (28.3)

4. Secondary Outcome

Title	Worst Arm Pain Visual Analog Scale
Description	Improvement of ≥20mm in worst arm pain at 24 months compared to baseline.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	PCM Cervical Disc - Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	187	150
Number [participants]	148 67.9%	113 61.1%

5. Secondary Outcome

Title	Mean Worst Arm Pain Visual Analog Scale
Description	Mean worst arm pain at 24 months on a 0-100mm Visual Analog Scale (lower value is better).
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	PCM Cervical Disc - Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	187	150
Mean (Standard Deviation) [mm]	24.9 (29.2)	27.5 (28.3)

6. Secondary Outcome

Title	Clinically Significant Improvement on Neck Disability Index (NDI)
Description	Improvement in NDI of ≥20% at 24 months compared to baseline.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	PCM Cervical Disc - Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	187	151
Number [participants]	156 71.6%	123 66.5%

7. Secondary Outcome

Title	Clinically Significant Improvement on Neck Disability Index (NDI)
Description	Improvement in NDI of ≥15-points at 24 months compared to baseline.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	PCM Cervical Disc-Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	187	151
Number [participants]	149 68.3%	114 61.6%

8. Secondary Outcome

Title	Mean Neck Disability Index (NDI)
Description	Mean NDI at 24 months on a 0-100 scale (lower value is better).
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	PCM Cervical Disc - Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	187	151
Mean (Standard Deviation) [units on a scale]	21.8 (22.5)	25.5 (21.5)

9. Secondary Outcome

Title	Clinically Significant Improvement on SF-36 Physical Component Summary (PCS)
Description	Improvement of ≥15% on SF-36 PCS at 24 months compared to baseline.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	PCM Cervical Disc-Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	187	151
Number [participants]	133 61%	98 53%

10. Secondary Outcome

Title	Mean SF-36 Physical Component Summary (PCS)
Description	Mean SF-36 PCS at 24 months on a 0-100 scale (lower value is better).
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	PCM Cervical Disc-Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	187	151
Mean (Standard Deviation) [units on a scale]	46.6 (11.0)	45.0 (10.6)

11. Secondary Outcome

Title	Clinically Significant Improvement on SF-36 Mental Component Summary (MCS)
Description	Improvement of ≥15% on the SF-36 MCS at 24 months compared to baseline.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	PCM Cervical Disc-Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	187	151
Number [participants]	87 39.9%	75 40.5%

12. Secondary Outcome

Title	Mean SF-36 Mental Component Summary (MCS)
Description	Mean SF-36 MCS at 24 months on a 0-100 scale (lower value is better).
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	PCM Cervical Disc-Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	187	151
Mean (Standard Deviation) [units on a scale]	50.3 (11.1)	49.3 (11.4)

13. Secondary Outcome

Title	Dysphagia for Swallowing
Description	Mean dysphagia for swallowing at 24 months on a 0-100mm Visual Analog Scale (lower value is better).
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	PCM Cervical Disc-Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	183	147
Mean (Standard Deviation) [mm]	8.8 (16.3)	12.1 (20.1)

14. Secondary Outcome

Title	Patient Satisfaction
Description	Mean Patient Satisfaction at 24 months on a 0-100 Visual Analog Scale (higher value is better).
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	PCM Cervical Disc-Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	182	146
Mean (Standard Deviation) [mm]	82.8 (27.1)	81.4 (25.7)

15. Secondary Outcome

Title	Nurick's Classification of Disability (Myelopathy)
Description	Maintenance or improvement in Nurick's Classification from baseline to 24 months. Nurick's classification is a six-point scale, graded 0 to 5. A grade of 0 indicates no symptoms at all, while a grade of 5 is a bed or chair-bound patient. A patient "maintained" if their Nurick classification grade remained the same or "improved" if it decreased from baseline to 24 months.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per protocol with extended windows

Arm/Group Title	PCM Cervical Disc-Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	185	153
Number [participants]	185 84.9%	148 80%

16. Secondary Outcome

Title	Flexion/Extension Range of Motion at the Operative Level
Description	Mean flexion/extension range of motion at operative level at 24 months. The operative level is defined as the cervical spinal level at which the surgical procedure was performed.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	PCM Cervical Disc-Investigational	Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1	Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Measure Participants	182	151
Mean (Standard Deviation) [degrees]	5.7 (3.9)	0.8 (0.8)

Adverse Events

Time Frame	Operative timepoint through 24 months.
Adverse Event Reporting Description	For AEs, Safety population used (all treated patients (pts) analyzed as-treated). One non-randomized investigational training pt and 4 randomized PCM pts were intraoperatively switched to receive ACDF so all included in ACDF group (N=190) and 4 randomized PCM pts were removed from randomized PCM group (N=214).
Arm/Group Title	PCM Cervical Disc-Investigational		Anterior Cervical Discectomy and Fusion - Control Group
Arm/Group Description	PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1		Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
All Cause Mortality
	PCM Cervical Disc-Investigational		Anterior Cervical Discectomy and Fusion - Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	PCM Cervical Disc-Investigational		Anterior Cervical Discectomy and Fusion - Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	68/214 (31.8%)		57/190 (30%)
Cardiac disorders
Systemic - Cardiac Events	3/214 (1.4%)	3	3/190 (1.6%)	3
Gastrointestinal disorders
Systemic- Gastrointestinal	4/214 (1.9%)	5	2/190 (1.1%)	2
General disorders
Systemic - Other	7/214 (3.3%)	7	11/190 (5.8%)	11
Systemic - Urogenital	0/214 (0%)	0	6/190 (3.2%)	6
Infections and infestations
Systemic - Infection	5/214 (2.3%)	5	3/190 (1.6%)	4
Injury, poisoning and procedural complications
Implant Related - Spinal Event	3/214 (1.4%)	4	0/190 (0%)	0
Implant Related - Trauma	1/214 (0.5%)	1	1/190 (0.5%)	1
Surgery Related - Neck/Arm Pain	2/214 (0.9%)	2	4/190 (2.1%)	4
Surgery Related - Spinal Event	0/214 (0%)	0	2/190 (1.1%)	2
Systemic - Musculoskeletal Trauma	4/214 (1.9%)	4	8/190 (4.2%)	10
Investigations
Implant Related - Implant Displacement/Loosening	8/214 (3.7%)	8	0/190 (0%)	0
Implant Related - Subsidence	1/214 (0.5%)	1	0/190 (0%)	0
Musculoskeletal and connective tissue disorders
Implant Related-Adjacent Level Disease	4/214 (1.9%)	4	4/190 (2.1%)	4
Implant Related - Non Union	0/214 (0%)	0	2/190 (1.1%)	3
Systemic - Musculoskeletal Adjacent Level Disease	1/214 (0.5%)	1	0/190 (0%)	0
Systemic - Musculoskeletal / Back/Leg Pain	14/214 (6.5%)	18	5/190 (2.6%)	5
Systemic - Musculoskeletal / Neck/Arm Pain	7/214 (3.3%)	10	8/190 (4.2%)	9
Systemic - Musculoskeletal / Other	10/214 (4.7%)	10	2/190 (1.1%)	2
Systemic - Musculoskeletal / Spinal Event	10/214 (4.7%)	10	11/190 (5.8%)	11
Nervous system disorders
Surgery Related - Neurological	2/214 (0.9%)	2	3/190 (1.6%)	3
Systemic - Neurologic	0/214 (0%)	0	2/190 (1.1%)	2
Psychiatric disorders
Systemic - Mental Disorders	0/214 (0%)	0	3/190 (1.6%)	3
Respiratory, thoracic and mediastinal disorders
Systemic - Respiratory	0/214 (0%)	0	1/190 (0.5%)	1
Other (Not Including Serious) Adverse Events
	PCM Cervical Disc-Investigational		Anterior Cervical Discectomy and Fusion - Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	180/214 (84.1%)		163/190 (85.8%)
Cardiac disorders
Systemic - Cardiac Events	7/214 (3.3%)		6/190 (3.2%)
Gastrointestinal disorders
Systemic - Gastrointestinal	12/214 (5.6%)		6/190 (3.2%)
Surgery Related - Gastrointestinal	2/214 (0.9%)		2/190 (1.1%)
General disorders
Systemic - Other	42/214 (19.6%)		26/190 (13.7%)
Implant Related - Other	1/214 (0.5%)		1/190 (0.5%)
Surgery Related - Other	4/214 (1.9%)		7/190 (3.7%)
Surgery Related - Urogenital	0/214 (0%)		2/190 (1.1%)
Systemic - Dysphagia/Dysphonia	2/214 (0.9%)		4/190 (2.1%)
Systemic - Mental Disorder	2/214 (0.9%)		4/190 (2.1%)
Systemic - Urogenital	2/214 (0.9%)		8/190 (4.2%)
Infections and infestations
Systemic - Infection	15/214 (7%)		12/190 (6.3%)
Surgery Related - Infection	1/214 (0.5%)		1/190 (0.5%)
Injury, poisoning and procedural complications
Surgery related - dysphagia/dysphonia	14/214 (6.5%)		23/190 (12.1%)
Surgery related - Incision Site	12/214 (5.6%)		4/190 (2.1%)
Surgery Related - Neck / Arm Pain	21/214 (9.8%)		32/190 (16.8%)
Systemic - Musculoskeletal Trauma	42/214 (19.6%)		32/190 (16.8%)
Implant Related - Trauma	1/214 (0.5%)		1/190 (0.5%)
Surgery Related - Spinal Event	2/214 (0.9%)		8/190 (4.2%)
Surgery Related - Vertebral Fracture	1/214 (0.5%)		0/190 (0%)
Systemic - Other Trauma	6/214 (2.8%)		2/190 (1.1%)
Investigations
Implant Related - Implant Displacement/Loosening	10/214 (4.7%)		1/190 (0.5%)
Implant Related - Radiolucency	3/214 (1.4%)		3/190 (1.6%)
Implant Related - Subsidence	1/214 (0.5%)		2/190 (1.1%)
Musculoskeletal and connective tissue disorders
Implant Related - Adjacent Level Disease	5/214 (2.3%)		27/190 (14.2%)
Implant Related - Non Union	0/214 (0%)		11/190 (5.8%)
Implant Related - Spinal Event	11/214 (5.1%)		4/190 (2.1%)
Systemic - Musculoskeletal / Back/Leg Pain	36/214 (16.8%)		33/190 (17.4%)
Systemic - Musculoskeletal / Neck/Arm Pain	87/214 (40.7%)		68/190 (35.8%)
Systemic - Musculoskeletal / Other	29/214 (13.6%)		17/190 (8.9%)
Systemic - Musculoskeletal / Spinal Event	32/214 (15%)		22/190 (11.6%)
Implant Related - Neck/Arm Pain	0/214 (0%)		1/190 (0.5%)
Systemic - Musculoskeletal/Adjacent Level Disease	2/214 (0.9%)		1/190 (0.5%)
Nervous system disorders
Surgery Related - Neurologic	12/214 (5.6%)		10/190 (5.3%)
Systemic - Neurologic	12/214 (5.6%)		27/190 (14.2%)
Respiratory, thoracic and mediastinal disorders
Surgery Related - Respiratory	1/214 (0.5%)		0/190 (0%)
Systemic - Respiratory	3/214 (1.4%)		2/190 (1.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Investigators and Institutions will allow NuVasive to review and comment on any presentation or publication of any study information prior to its release to ensure such documents are accurate and do not disclose any trade secret or other confidential information. No information may be disclosed regarding the study without NuVasive's written permission.