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25 July 2008
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| [ Print-friendly version ] |
| Study on cervical resorbable interbody cages |
| ISRCTN | ISRCTN57772706 |
| ClinicalTrials.gov identifier | |
| Public title | Study on cervical resorbable interbody cages |
| 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 |
| Serial number at source | SLCRG2007001 |
| 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 on the 17th August 2007 (ref: 2007/58) 2. Germany: Ethik-Kommission der Bayerischen Landesärztekammer on the 19th June 2007 (ref: 07036) 3. Denmark: Den Videnskabsetiske Komité for region Syddanmark on the 7th July 2007 (ref: S-20070049) 4. France: CPP Est-II CHU Hôpital St Jacques on the 10th September 2007 (ref: 07/451) 5. Spain: Comité Ético de Investigación Clínica del Hospital Universitario de la Princesa on the 15th October 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 |
| Countries of recruitment | Netherlands, Germany, Denmark, France, United Kingdom, Spain |
| Disease/condition/study domain | Degenerative disc disease of the cervical spine |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/08/2007 |
| Anticipated end date | 31/12/2010 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 113 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Stryker SA (Switzerland) |
| Trial website | |
| Publications | |
| Contact name | Dr T.U. Jiya |
| Address |
VU University Medical Center
Department of Orthopedics De Boelelaan 1117 |
| City/town | Amsterdam |
| Zip/Postcode | 1081 HV |
| Country | Netherlands |
| Sponsor | Stryker SA (Switzerland) |
| Address |
Stryker SA SLCRG
Cité-Centre, Grand-rue 92 P.O. Box 1568 |
| City/town | Montreux |
| Zip/Postcode | 1820 |
| Country | Switzerland |
| Tel | +41 (0)21 966 1201 |
| Fax | +41 (0)21 966 1200 |
| Andrea.Donelli@stryker.com | |
| Sponsor website: | http://www.europe.stryker.com/ |
| Date applied | 22/02/2008 |
| Last edited | 03/04/2008 |
| Date ISRCTN assigned | 03/04/2008 |
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