Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00667459

Enrollment

280

Registered

2008-04-28

Start date

2005-01-31

Completion date

2014-06-30

Last updated

2023-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Degenerative Disc Disease

Keywords

Cervical Disc

Brief summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.

Detailed description

This pivotal clinical trial was conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc devices were implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (NCT00642876) were compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.

Interventions

DEVICEPRESTIGE® LP Cervical Disc

The PRESTIGE® LP Cervical Disc was inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.

DEVICEATLANTIS Anterior Cervical Plate

Anterior cervical discectomy and fusion with ATLANTIS plate for control group

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Has cervical degenerative disc disease as defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression that is documented by patient history: a) herniated disc; b) osteophyte formation * One level requiring surgical treatment * C3-C4 disc to C6-C7 disc level involvement * Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or signs of cord compression * No previous surgical procedures at the involved level or any planned surgical procedure at the involved or adjacent level. * Preop Neck Disability index score ≥ 30 * Preop Neck Pain score of ≥ 20 based on the Preop Neck & Arm Pain Questionnaire * Not pregnant at time of surgery * Willing and able to comply with study plan and able to understand and sign patient informed consent

Exclusion criteria

* Any other cervical spinal condition requiring surgical treatment at the involved level * Documented or diagnosed cervical instability defined by radiographs showing 1. Sagittal plane translation \> 3.5mm or 2. Sagittal plane angulation \> 20 degrees. * More than one cervical level requiring surgery * A fused level adjacent to the level to be treated * Severe pathology of the facet joint of involved bodies * Previous surgery at the involved level * Previously diagnosed osteopenia or osteomalacia * Any of the following that may be associated with an osteoporosis diagnosis (if Yes to any of these, a DEXA Scan will be required to determine eligibility) 1. Postmenopausal non-Black female over 60 years of age and weighs less than 140 pounds 2. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture 3. Male over the age of 70 4. Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If the level of Bone Mineral Density is a T score of -3.5 or lower or a T score of -2.5 or lower with the vertebral crush fracture, then the patient is excluded. * Presence of spinal metastases * Overt or active bacterial infection, either local or systemic * Severe insulin dependent diabetes * Chronic or acute renal failure or history of renal disease * Temperature \> 101º F oral at surgery * Documented allergy to stainless steel, titanium or a titanium alloy * Mentally incompetent * Is a prisoner * Is pregnant * Is an alcohol and/or drug abuser * Has received drugs which may interfere with bone metabolism within 2 weeks prior to the planned surgery date (steroids, methotrexate), excluding routine preop anti-inflammatories) * A history of endocrine or metabolic disorder known to affect osteogenesis * A condition that requires postop medications that interfere with the stability of the implant (steroids). This does not include low dose aspirin therapy. * Received treatment with an investigational therapy within 28 days prior to surgery or planned for 16 weeks following implantation.

Design outcomes

Primary

Measure	Time frame	Description
Rate of Overall Success	24 months	Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative; 2. Maintenance or improvement in neurological status; 3. Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of Postoperative Height - 6 Week Postoperative Height ≥ -2mm; 4. No serious adverse event classified as implant associated or implant/surgical procedure associated; and 5. No secondary surgical procedure classified as a failure.

Secondary

Measure	Time frame	Description
Success Rate of Neck Disability Index	24 months	Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.
Success Rate of Neurological Status	24 months	Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
Rate of Disc Height Success	24 months	Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height \>= -2mm
Neck Pain Success Rate	24 months	Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score \> 0.
Arm Pain Success Rate	24 months	Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score \> 0.
Success Rate of SF-36 PCS	24 months	Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score \>= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.
Hospital Stay	During the time of hospital stay, average of 1 day.	—
Success Rate of SF-36 MCS	24 months	Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score \>= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.
Gait Success Rate	24 months	Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score \>= 0. The gait success rate is reported as the percentage of participants who had gait success.
Operative Time	Time of operation, approximately 1.5 hrs.	Operative time was recorded from skin incision to wound closure.
Blood Loss	During the time of operation, approximately 1.5 hours.	—
Rate of Secondary Surgery at Index Level	24 months post-operation	Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of patients who had secondary surgeries at index level.
Change of Neck Disability Index Score From Baseline	Baseline and 24 months post-operation	The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.
Change of Neck Pain Score From Baseline	Baseline and 24 months post-operation	Numerical rating scales were used to evaluate neck pain intensity and frequency. Patients rated their neck pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their neck pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total neck pain score (0 to100) was the product of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.
Change of Arm Pain Score From Baseline	Baseline and 24 months post-operation	Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 100) was the product of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.
Change of General Health Status -- SF-36 PCS From Baseline	Baseline and 24 months post-operation	The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.
Change of General Health Status -- SF-36 MCS From Baseline	Baseline and 24 months post-operation	The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Investigational PRESTIGE® LP Cervical Disc	280
Control Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).	265
Total	545

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	0	2
Overall Study	Lost to Follow-up	8	43

Baseline characteristics

Characteristic	Control	Total	Investigational
Age, Continuous	43.9 years STANDARD_DEVIATION 8.8	44.2 years STANDARD_DEVIATION 8.8	44.5 years STANDARD_DEVIATION 8.8
Alcohol Used No	124 participants	254 participants	130 participants
Alcohol Used Yes	141 participants	291 participants	150 participants
Education Level < High School	14 participants	29 participants	15 participants
Education Level > High School	173 participants	379 participants	206 participants
Education Level High School	77 participants	134 participants	57 participants
Education Level Unknown	1 participants	3 participants	2 participants
Height	67.5 in. STANDARD_DEVIATION 4.2	67.6 in. STANDARD_DEVIATION 4.2	67.7 in. STANDARD_DEVIATION 4.1
Marital Status Divorced	24 participants	66 participants	42 participants
Marital Status Married	204 participants	393 participants	189 participants
Marital Status Separated	3 participants	10 participants	7 participants
Marital Status Single	32 participants	72 participants	40 participants
Marital Status Widowed	2 participants	4 participants	2 participants
Preop Work Status No	99 participants	191 participants	92 participants
Preop Work Status Yes	166 participants	354 participants	188 participants
Race/Ethnicity, Customized Asian	2 participants	2 participants	0 participants
Race/Ethnicity, Customized Black	13 participants	20 participants	7 participants
Race/Ethnicity, Customized Caucasian	243 participants	514 participants	271 participants
Race/Ethnicity, Customized Hispanic	6 participants	7 participants	1 participants
Race/Ethnicity, Customized Other	1 participants	2 participants	1 participants
Sex: Female, Male Female	143 Participants	294 Participants	151 Participants
Sex: Female, Male Male	122 Participants	251 Participants	129 Participants
Tobacco Used No	173 participants	379 participants	206 participants
Tobacco Used Yes	92 participants	166 participants	74 participants
Unresolved Spinal Litigation No	233 participants	479 participants	246 participants
Unresolved Spinal Litigation Yes	32 participants	66 participants	34 participants
Weight	184.7 lbs. STANDARD_DEVIATION 41.5	185.8 lbs. STANDARD_DEVIATION 43.3	186.9 lbs. STANDARD_DEVIATION 45
Worker's Compensation Case No	230 participants	478 participants	248 participants
Worker's Compensation Case Yes	35 participants	67 participants	32 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	242 / 280	211 / 265
serious Total, serious adverse events	133 / 280	98 / 265

Outcome results

Primary

Rate of Overall Success

Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative; 2. Maintenance or improvement in neurological status; 3. Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of Postoperative Height - 6 Week Postoperative Height ≥ -2mm; 4. No serious adverse event classified as implant associated or implant/surgical procedure associated; and 5. No secondary surgical procedure classified as a failure.

Time frame: 24 months

Population: The primary analysis dataset for this study consists of all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 226 investigational subjects and 171 control subjects.

Arm	Measure	Value (NUMBER)
Investigational	Rate of Overall Success	70.4 percentage of participants
Control	Rate of Overall Success	63.2 percentage of participants

Comparison: The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.p-value: 0.99595% CI: [-0.07, 0.134]Bayesian logistic model

Comparison: Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.p-value: 0.736Bayesian logistic model

Secondary

Arm Pain Success Rate

Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be.) and frequency scales (0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score \> 0.

Time frame: 24 months

Population: For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 268 subjects in the investigational group and 219 subjects in the control group.

Arm	Measure	Value (NUMBER)
Investigational	Arm Pain Success Rate	96.3 percentage of participants
Control	Arm Pain Success Rate	95.0 percentage of participants

Comparison: The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.p-value: 195% CI: [-0.018, 0.058]Bayesian logistic model

Secondary

Blood Loss

Time frame: During the time of operation, approximately 1.5 hours.

Population: For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for blood loss, which leads to 278 subjects in the investigational group and 263 subjects in the control group.

Arm	Measure	Value (MEAN)	Dispersion
Investigational	Blood Loss	50.5 ml	Standard Deviation 73.5
Control	Blood Loss	57.5 ml	Standard Deviation 68.1

Comparison: Superiority comparison of the blood loss in two treatment groups was assessed.p-value: 0.769Bayesian logistic model

Secondary

Change of Arm Pain Score From Baseline

Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients rated their arm pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, patients recorded their arm pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total arm pain score (0 to 100) was the product of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.