Study on cervical resorbable interbody cages

ISRCTN	ISRCTN57772706
DOI	https://doi.org/10.1186/ISRCTN57772706
Secondary identifying numbers	SLCRG2007001

Submission date: 22/02/2008
Registration date: 03/04/2008
Last edited: 05/01/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr T.U. Jiya
Scientific

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

Study information

Study design	Multi-centre European prospective randomised controlled single-blinded outcome study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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 acronym	CLEAR
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/08/2007
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	113
Key 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
Key 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
Date of first enrolment	01/08/2007
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Denmark
France
Germany
Netherlands
Spain
United Kingdom

Study participating centre

VU University Medical Center

Amsterdam
1081 HV
Netherlands

Sponsor information

Stryker SA (Switzerland)
Industry

Stryker SA SLCRG
Cité-Centre, Grand-rue 92
P.O. Box 1568
Montreux
1820
Switzerland

Phone	+41 (0)21 966 1201
Email	Andrea.Donelli@stryker.com
Website	http://www.europe.stryker.com/
"ROR"	https://ror.org/04t7jet59

Funders

Funder type

Industry

Stryker SA (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan