Condition category
Musculoskeletal Diseases
Date applied
19/02/2006
Date assigned
11/04/2006
Last edited
26/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roland Donk

ORCID ID

Contact details

Weg door Jonkerbos 100
Nijmegen
6532 SZ
Netherlands
+31 (0)24 3658855
r.donk@cwz.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PROCON

Study hypothesis

PROCON was designed to assess the clinical outcome, development of adjacent disc disease and costs of cervical anterior discectomy without fusion, with fusion using a stand-alone cage and implantation of a Bryan’s disc prosthesis. The Bryan's disc is supposed to act better than the other two.

Ethics approval

The Medical Ethics Committee have fully approved the study and its design on the 25th June 2003 (ref: 103/2003).

Study design

A multicentre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cervical disk herniation with radiculopathy

Intervention

Anterior surgery without any fusion, with fusion using a cage or arthoplasty

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Clinical outcome after one year estimated by patient self reports:
1. McGill pain questionnaire-Dutch language version (MPQ-DLV)
2. Neck disability
3. 36-item short form questionnaire (SF-36)

Secondary outcome measures

1. Kyphosis on plain x-rays after one and five years
2. MRI at five years to elucidate the quality of the adjacent discs

Overall trial start date

01/09/2004

Overall trial end date

01/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 to 55 years
2. Cervical monoradicular symptoms
3. Magnetic resonance imaging (MRI): herniated cervical intervertebral disc and/or osteophyte in accordance with clinical symptoms and signs
4. Involved level not fused

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

270

Participant exclusion criteria

1. Symptoms and/or signs of myelopathy
2. Previous cervical surgery
3. Psychiatric or mental disease
4. Involvement of liability procedure
5. Alcoholism (drinking more than five units)
6. Insufficient of the Dutch language
7. Participation in another study
8. Two or more levels involved

Recruitment start date

01/09/2004

Recruitment end date

01/09/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Weg door Jonkerbos 100
Nijmegen
6532 SZ
Netherlands

Sponsor information

Organisation

Canisius-Wilhelmina Hopsital (CWZ) (The Netherlands)

Sponsor details

Weg door Jonkerbos 100
Nijmegen
6532 SZ
Netherlands
r.bartels@nch.umcn.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Canisius-Wilhelmina Hopsital (CWZ) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Trial design in http://www.ncbi.nlm.nih.gov/pubmed/17096851

Publication citations

  1. Trial design

    Bartels RH, Donk R, van der Wilt GJ, Grotenhuis JA, Venderink D, Design of the PROCON trial: a prospective, randomized multi-center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty., BMC Musculoskelet Disord, 2006, 7, 85, doi: 10.1186/1471-2474-7-85.

Additional files

Editorial Notes