NCT02350621

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

January 26, 2015

Last Update Submit

January 26, 2015

Conditions

Radiculopathy

Keywords

cervical foraminal stenosis minimal invasive foraminotomy

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index

    24 months

Study Arms (2)

ACDF

ACTIVE COMPARATOR

Anterior Cervical Discectomy and Fusion

Procedure: ACDF

miPCF

ACTIVE COMPARATOR

minimal invasive Posterior Cervical Foraminotomy

Procedure: minimal invasive Posterior Cervical Foraminotomy

Interventions

ACDFPROCEDURE
ACDF
minimal invasive Posterior Cervical ForaminotomyPROCEDURE
miPCF

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Tycho Tullberg, MD, PhD

    Stockholm Spine Center

    STUDY CHAIR

Central Study Contacts

Andreas Selander, MD

CONTACT

andreas.selander@spinecenter.se

Anton Rasch, MD, PhD

CONTACT

anton.rasch@spinecenter.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 26, 2015

First Posted

January 29, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2018

Last Updated

January 29, 2015

Record last verified: 2015-01