Post-Approval Clinical Trial of the PCM® Cervical Disc

Radiculopathy Clinical Trial

Official title:

A Prospective, Randomized, Multi-Center, Post-Approval Clinical Trial Evaluating the Long-Term (7 Year) Safety and Effectiveness of the PCM® Cervical Disc

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905930
• Other study ID #: NUVA-PCM-1101
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2013
• Last updated: May 19, 2015
• Start date: April 2013
• Est. completion date: April 2015

Study information

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

Clinical Trial Summary

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.

The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.

Description:

A prospective, multi-center, post approval study with concurrent control group consisting of those patients that were enrolled and did not fail in the PCM Cervical Disc IDE clinical study and will to give consent to participate.

All of the PCM IDE investigational sites who have active patients will be chosen to participate in this study. All patients who are actively participating in the pivotal IDE study will be asked to participate in this study.

The study consists of follow-up periods only. The follow-up period will last for seven years from each patient's surgery date.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients enrolled in the PCM Cervical Disc IDE clinical study

• Patients willing and able to give informed consent

Exclusion Criteria:

• Patients considered failure during the PCM Cervical Disc IDE clinical study

• Patients who were withdrawn during the PCM Cervical Disc IDE clinical study

Study Design

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

Related Conditions & MeSH terms

• Myelopathy
• Radiculopathy

Intervention

Device:
• PCM Cervical Disc
Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1
• Anterior Cervical Discectomy and Fusion (ACDF)
Patients enrolled in the IDE clinical study and treated with an 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

Locations

Country	Name	City	State
United States	NeuroSpine Center of Wisconsin	Appleton	Wisconsin
United States	Spine Group Beverly Hills	Beverly Hills	California
United States	Chicago Back Institute	Chicago	Illinois
United States	Midwest Orthopedic Associates at Rush	Chicago	Illinois
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Columbia Orthopedic Research	Columbia	Missouri
United States	Denver Spine	Greenwood Village	Colorado
United States	Goodman Campbell Brain and Spine	Indianapolis	Indiana
United States	Buffalo Spine Surgery	Lockport	New York
United States	Neuroscience Specialists	Oklahoma City	Oklahoma
United States	Olympia Othopaedic Associates	Olympia	Washington
United States	The Rothman Institute	Philadelphia	Pennsylvania
United States	Wm. Beaumont Hospital	Southfield	Michigan
United States	Institute for Spine Care	Syracuse	New York
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Scott and White Memorial Hospital	Temple	Texas
United States	Towson Orthopedic Associates	Towson	Maryland
United States	Virginia Brain and Spine	Winchester	Virginia

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	Improvement of at least 20% on the Neck Disability Index (NDI) at 7 years compared to baseline; No device failures requiring revision, reoperation, removal or supplemental fixation; No major complications such as vascular or neurological injury; Radiographic success	7 years	Yes

External Links

•   Link