A prospective, randomised multicentre study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty

ISRCTN	ISRCTN41681847
DOI	https://doi.org/10.1186/ISRCTN41681847
Protocol serial number	N/A
Sponsor	Canisius-Wilhelmina Hopsital (CWZ) (The Netherlands)
Funder	Canisius-Wilhelmina Hopsital (CWZ) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Roland Donk
Scientific

Weg door Jonkerbos 100
Nijmegen
6532 SZ
Netherlands

Phone	+31 (0)24 3658855
Email	r.donk@cwz.nl

Primary study design	Interventional
Study design	A multicentre, randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A prospective, randomised multicentre study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty
Study acronym	PROCON
Study objectives	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 Bryans disc prosthesis. The Bryan's disc is supposed to act better than the other two.
Ethics approval(s)	The Medical Ethics Committee have fully approved the study and its design on the 25th June 2003 (ref: 103/2003).
Health condition(s) or problem(s) studied	Cervical disk herniation with radiculopathy
Intervention	Anterior surgery without any fusion, with fusion using a cage or arthoplasty
Intervention type	Other
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	1. Kyphosis on plain x-rays after one and five years 2. MRI at five years to elucidate the quality of the adjacent discs
Completion date	01/09/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	270
Key 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
Key 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 knowledge of the Dutch language 7. Participation in another study 8. Two or more levels involved
Date of first enrolment	01/09/2004
Date of final enrolment	01/09/2009

Weg door Jonkerbos 100

Nijmegen
6532 SZ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/08/2017	01/03/2021	Yes	No
Results article	results	01/11/2020	01/03/2021	Yes	No
Results article	results	01/02/2018	01/03/2021	Yes	No
Results article	results	01/05/2017	01/03/2021	Yes	No
Protocol article	protocol	10/11/2006		Yes	No

01/03/2021: Publication references added.
14/09/2017: internal review.