Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion

NCT03041896 | Completed Results

• 1 other identifier: CRDC2016
• Study Type: observational
• Target: 5,050
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2 levels with the coflex® Interlaminar Technology or decompression with or without fusion.

Conditions

Spinal Stenosis

Outcome Measures

Primary Outcomes (2)

• Overall Duration of Follow-up Care to Evaluate Overall Effectiveness of the Use of the Coflex® Interlaminer Technology

  To assess the overall duration of follow-up care to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology verses decompression.

  Study Duration Up to 6 months for data collection

• Overall Incidence of Secondary Surgical Interventions Post Surgeries.

  To analyze the incidence of secondary surgical interventions to evaluate overall effectiveness of the use of the coflex® Interlaminer Technology vs. decompression.

  Study Duration up to 6 months data

Secondary Outcomes (1)

• The Secondary Objectives Include Measuring and Comparing Clinical, Radiologic, and Patient Reported Outcomes at Baseline, Interim and/or Final Follow-up Visits.

  Study Duration Up to 6 months for data collection

Study Arms (4)

Decompression

Standard of care decompression for spinal stenosis, 1 or 2 levels.

Device: coflex® Interlaminar Technology

Fusion

Standard pedical and rod fixation with standard decompression, 1 or 2 levels.

Device: coflex® Interlaminar Technology

coflex®

Decompression surgery with the coflex® Interlaminar Technology, 1 or 2 levels.

Device: coflex® Interlaminar Technology

Hybrid

coflex and fusion at adjacent levels

Device: coflex® Interlaminar Technology

Interventions

coflex® Interlaminar Technology DEVICE

Interlaminer Technology

Decompression; Fusion; Hybrid; coflex®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients must meet the criteria specified in the device labeling including radiographic confirmation of at least moderate lumbar stenosis, which narrows the central spinal canal at one or two contiguous levels from L1-L5 that require surgical decompression.

You may qualify if:

• Patients must meet the criteria specified in the device labeling including radiographic confirmation of at least moderate lumbar stenosis, which narrows the central spinal canal at one or two contiguous levels from L1-L5 that require surgical decompression.

Sponsors & Collaborators

• Paradigm Spine: lead
• MCRA: collaborator

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Glenn Stiegman
• Organization: MCRA

gstiegman@mcra.com

2025525800

Study Officials

• Abigail Allen

  MCRA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: February 3, 2017
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: August 1, 2018
• Last Updated: May 19, 2020
• Results First Posted: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share