Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SLCRG2007001
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
Acronym
CLEAR
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Degenerative disc disease of the cervical spine
Intervention
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
Procedure/Surgery
Phase
Drug names
Primary outcome measures
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
01/08/2007
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
113
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
01/08/2007
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Denmark, France, Germany, Netherlands, Spain, United Kingdom
Trial participating centre
VU University Medical Center
Amsterdam
1081 HV
Netherlands
Sponsor information
Organisation
Stryker SA (Switzerland)
Sponsor details
Stryker SA SLCRG
Cité-Centre
Grand-rue 92
P.O. Box 1568
Montreux
1820
Switzerland
+41 (0)21 966 1201
Andrea.Donelli@stryker.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Stryker SA (Switzerland)
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