NCT01607775

Brief Summary

Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. As control, a commercially available PEEK-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. The investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2009

Typical duration for phase_1

Status
completed

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

Study Start

First participant enrolled

February 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

3 years

First QC Date

May 22, 2012

Last Update Submit

June 4, 2012

Conditions

Cervical Disc DegenerationCervical Stenosis

Outcome Measures

Primary Outcomes (1)

  • Clinical outcome (NDI)

    NDI (Neck disability index) will be measured prior to surgery and 12 months after surgery. A difference of 20% between both groups is considered to be clinically significant, which is proposed for the experimental implant (PMMA-cage).

    12 months postoperative

Secondary Outcomes (1)

  • Clinical outcome (VAS-neck), Subsidence

    12 months postoperative

Study Arms (2)

PEEK-cage

ACTIVE COMPARATOR

Patients will receive a PEEK-cage

Device: Implantation of a PEEK-cage

PMMA-cage

EXPERIMENTAL
Device: PMMA-cage

Interventions

Implantation of a PEEK-cageDEVICE

A commercially avaliable cuboid cervical cage will be implantet

PEEK-cage
PMMA-cageDEVICE

The in-house produced cervical cage will be implanted

PMMA-cage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • virgin spines
  • no emergency operation
  • age above 18
  • sufficient knowledge of the German language
  • indication for anterior cervical discectomy and fusion
  • absence of concomitant spinal disease

You may not qualify if:

  • prior cervical surgery
  • indications other than ACDF
  • concomitant neoplastic, metabolic, severe general or infectious disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M. D., Vice-chairman

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 30, 2012

Study Start

February 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

June 5, 2012

Record last verified: 2012-06