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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00578812
Other study ID # G040081
Secondary ID
Status Completed
Phase Phase 3
First received December 19, 2007
Last updated June 8, 2015
Start date January 2005
Est. completion date August 2014

Study information

Verified date June 2015
Source NuVasive
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
PCM Cervical Disc
PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1

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Sponsors (1)

Lead Sponsor Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Individual Patient Overall Success 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. 24 Months Yes
Secondary Neck Pain Visual Analog Scale Improvement of =20mm in neck pain at 24 months compared to baseline. 24 Months No
Secondary Mean Neck Pain Visual Analog Scale Mean neck pain at 24 months on a 0-100 mm Visual Analog Scale (lower value is better). 24 Months No
Secondary Worst Arm Pain Visual Analog Scale Improvement of =20mm in worst arm pain at 24 months compared to baseline. 24 Months No
Secondary Mean Worst Arm Pain Visual Analog Scale Mean worst arm pain at 24 months on a 0-100mm Visual Analog Scale (lower value is better). 24 Months No
Secondary Clinically Significant Improvement on Neck Disability Index (NDI) Improvement in NDI of =20% at 24 months compared to baseline. 24 Months No
Secondary Clinically Significant Improvement on Neck Disability Index (NDI) Improvement in NDI of =15-points at 24 months compared to baseline. 24 Months No
Secondary Mean Neck Disability Index (NDI) Mean NDI at 24 months on a 0-100 scale (lower value is better). 24 Months No
Secondary Clinically Significant Improvement on SF-36 Physical Component Summary (PCS) Improvement of =15% on SF-36 PCS at 24 months compared to baseline. 24 Months No
Secondary Mean SF-36 Physical Component Summary (PCS) Mean SF-36 PCS at 24 months on a 0-100 scale (lower value is better). 24 Months No
Secondary Clinically Significant Improvement on SF-36 Mental Component Summary (MCS) Improvement of =15% on the SF-36 MCS at 24 months compared to baseline. 24 Months No
Secondary Mean SF-36 Mental Component Summary (MCS) Mean SF-36 MCS at 24 months on a 0-100 scale (lower value is better). 24 Months No
Secondary Dysphagia for Swallowing Mean dysphagia for swallowing at 24 months on a 0-100mm Visual Analog Scale (lower value is better). 24 Months No
Secondary Patient Satisfaction Mean Patient Satisfaction at 24 months on a 0-100 Visual Analog Scale (higher value is better). 24 Months No
Secondary Nurick's Classification of Disability (Myelopathy) 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. 24 Months Yes
Secondary Flexion/Extension Range of Motion at the Operative Level 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. 24 Months No
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