Condition category
Musculoskeletal Diseases
Date applied
22/02/2008
Date assigned
03/04/2008
Last edited
06/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr T.U. Jiya

ORCID ID

Contact details

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

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

http://www.europe.stryker.com/

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

Publication citations

Additional files

Editorial Notes

06/06/2016: No publications found, verifying study status with principal investigator.