Ignite Creation Date:
2024-05-05 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00578812
Status:
COMPLETED
Last Update Posted:
2015-07-07
First Post:
2007-12-19
Brief Title:
PCM Cervical Disc System
Sponsor:
NuVasive
Organization:
NuVasive
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 andor visible loss of disc height as compared to adjacent levels
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 andor 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 andor visible loss of disc height as compared to adjacent levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None