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Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis

NCT ID: NCT00534235

Last Updated: 2020-02-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-12-31

Brief Summary

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Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis

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Detailed Description

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The primary objective of this post-approval study is to examine the long-term survivorship of the coflex®. The coflex® Interlaminar Technology is an interlaminar stabilization device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The coflex® is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. Interlaminar stabilization is performed after decompression of stenosis at the affected level(s).

Conditions

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Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Posterolateral Fusion w/Pedicle Screws

Control: Posterolateral fusion and implantation of pedicle screws after decompression

Group Type ACTIVE_COMPARATOR

Decompression

Intervention Type PROCEDURE

Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain

Posterolateral Fusion and Implantation of Pedicle Screws

Intervention Type DEVICE

coflex Interlaminar Technolgy

Investigative: Implantation of coflex Interlaminar Technology after decompression

Group Type ACTIVE_COMPARATOR

Decompression

Intervention Type PROCEDURE

Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain

Implantation of coflex Interlaminar Technology

Intervention Type DEVICE

Interventions

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Decompression

Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain

Intervention Type PROCEDURE

Posterolateral Fusion and Implantation of Pedicle Screws

Intervention Type DEVICE

Implantation of coflex Interlaminar Technology

Intervention Type DEVICE

Eligibility Criteria

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Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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MCRA

INDUSTRY

Sponsor Role collaborator

Paradigm Spine

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Davis R, Auerbach JD, Bae H, Errico TJ. Can low-grade spondylolisthesis be effectively treated by either coflex interlaminar stabilization or laminectomy and posterior spinal fusion? Two-year clinical and radiographic results from the randomized, prospective, multicenter US investigational device exemption trial: clinical article. J Neurosurg Spine. 2013 Aug;19(2):174-84. doi: 10.3171/2013.4.SPINE12636. Epub 2013 May 31.

Reference Type DERIVED
PMID: 23725394 (View on PubMed)

Related Links

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http://www.paradigmspine.com

Related Info

Other Identifiers

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PS-001

Identifier Type: -

Identifier Source: org_study_id

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