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Cervical Foraminal Stenosis and Radiculopathy - ACDF Versus Minimal Invasive Posterior Cervical Foraminotomy.

Cervical Foraminal Stenosis and Radiculopathy - Anterior Cervical Discectomy and Fusion (ACDF) Versus Minimal Invasive Posterior Cervical Foraminotomy miPCF).

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02350621
Enrollment
80
Registered
2015-01-29
Start date
2015-02-28
Completion date
2018-02-28
Last updated
2015-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiculopathy

Keywords

cervical foraminal stenosis minimal invasive foraminotomy

Brief summary

A prospective randomized clinical trial. Cervical spondylotic foraminal stenosis with radiculopahty. Comparison results between 2 treatment options: ACDF and minimal invasive posterior cervical foraminiotomy. 80 patients to be followed for 2 years. Parameters to study: NDI, VAS, EQ-5D, complications, health economics, recurrens of stenosis, movement of facet joints pre- and postoperatively (foraminotomy group).

Interventions

PROCEDUREACDF
PROCEDUREminimal invasive Posterior Cervical Foraminotomy

Sponsors

Stockholm Spine Center AB
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Cervical radiculopathy on 1 or 2 levels correlated on MRI and CT Arm pain more than 30 (VAS). Duration more than 3 months.

Exclusion criteria

* Myelopathy. Soft disc hernia. Previous neck surgery. Tumors, infection, WAD, trauma, generalized pain syndrome.

Design outcomes

Primary

MeasureTime frame
Neck Disability Index24 months

Contacts

Primary ContactAndreas Selander, MD
andreas.selander@spinecenter.se
Backup ContactAnton Rasch, MD, PhD
anton.rasch@spinecenter.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026