Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr T.U. Jiya


Contact details

VU University Medical Center
Department of Orthopedics
De Boelelaan 1117
1081 HV

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Solis (polyaryletheretherketone [PEEK]) versus Solis (poly-L-lactic acid [PLLA]) resorbable cage for anterior cervical discectomy with fusion: controlled randomised clinical outcomes study



Study hypothesis

Anterior cervical disc excision followed by interbody arthrodesis is a standard surgical procedure to treat patients with symptomatic cervical spondylosis. Resorbable materials have recently been introduced in spinal surgery. The advantage of these materials is that they offer the correct mechanical environment to achieve fusion, but are absorbed over time, therefore avoiding long term adverse events. The extent of this improvement needs to be assessed objectively and compared to current standard care.

Disease information:
Single level degenerative disc disease of the cervical spine at a level between C3-C4 and C6-C7 with symptomatic myelopathy and/or radiculopathy.

Ethics approval

Ethics approval received from:
1. Netherlands: VUmc METC, 17/08/2007, ref: 2007/58
2. Germany: Ethik-Kommission der Bayerischen Landesärztekammer, 19/06/2007, ref: 07036
3. Denmark: Den Videnskabsetiske Komité for region Syddanmark, 07/07/2007, ref: S-20070049
4. France: CPP Est-II CHU Hôpital St Jacques, 10/09/2007, ref: 07/451
5. Spain: Comité Ético de Investigación Clínica del Hospital Universitario de la Princesa, 15/10/2007, ref: 1189

Ethics approval pending as of 22/02/2008 from:
United Kingdom: Leeds (West) Research Ethics Committee, ref: 07/H1307/192

Study design

Multi-centre European prospective randomised controlled single-blinded outcome study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Degenerative disc disease of the cervical spine


Anterior cervical discectomy with fusion:
Group 1: Anterior single level cervical discectomy procedure with a Solis (non-resorbable PEEK) interbody cage device (no internal fixation)
Group 2: Anterior single level cervical discectomy procedure with a Solis RS (bioresorbable PLLA) interbody cage device (no internal fixation)

The follow-up time is two years for each patient.

Intervention type



Drug names

Primary outcome measure

1. Acquired fusion at six months
2. Subsidence and dynamic behaviour at every follow up
3. Absorption rate (for Solis RS only) at 24 months

Secondary outcome measures

1. Visual Analogue Scale (VAS) score for arm and neck pain at every follow up (3, 6, 12, 24 months)
2. Neck Disability Index (NDI) at every follow up
3. Myelopathy Disability Index (MDI) at every follow up
4. Prolo Economic and Functional Scale at every follow up

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Willing and able to participate
2. Patient is male or female and between 18 and 70 years of age
3. Patient has clinical symptomatic myelopathy and/or radiculopathy
4. Based on clinical history, physical examination and radiographic evidence, pain interpreted as emanating between C3/4 and C6/7
5. No improvement of symptoms after at least three months of conservative treatment
6. Progressive neurological deficit despite conservative management irrespective of the duration
7. Evidence of degenerative changes between levels C3/4 and C6/7 (“spondylosis”) as shown on plain radiographs and/or computed tomography (CT) scan and/or magnetic resonance imaging (MRI). The pathology should be predominant on one level. Other levels may show degeneration, however, it should not be clinically necessary to operate on.
8. Use of autograft from the iliac crest or the spine is necessary
9. Capable of providing informed consent

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Previous cervical spine surgery at the symptomatic level to be operated on and previous cervical spine surgery during the last two years at other levels
2. Symptomatic degenerative disc disorder at more than one cervical level
3. Pregnancy or planning a pregnancy during the two year study
4. Ongoing severe psychiatric illness or mental retardation
5. Evidence of alcohol and/or drug abuse
6. Inability to complete the questionnaires
7. Local or general infection which could jeopardise the surgical objective
8. Extensive local inflammatory reactions
9. Proven or suspected hypersensitivity to materials
10. Immunosuppressive pathologies
11. Abnormal, immature or weak bone structure, insufficient quantity or quality or diseased bone that is incapable of supporting or stabilising the device
12. Severe pathologies of the airway, oesophagus, abnormal vascostructure or bypassing nerves
13. Other indications than degenerative spinal disorders including a metabolic bone disease, osteoporosis, infection, previous cervical spinal fracture, inflammatory process or neoplasm (confirmed by radiographs and/or dual energy x-ray absorptiometry [DEXA] scans and/or CT and/or MRI)
14. Excessive physical activity

Recruitment start date


Recruitment end date



Countries of recruitment

Denmark, France, Germany, Netherlands, Spain, United Kingdom

Trial participating centre

VU University Medical Center
1081 HV

Sponsor information


Stryker SA (Switzerland)

Sponsor details

Stryker SA SLCRG
Grand-rue 92
P.O. Box 1568
+41 (0)21 966 1201

Sponsor type




Funder type


Funder name

Stryker SA (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes