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Study to Investigate the Performance of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease

This study has been terminated.
(study progress and recruitment rate too low)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00700739
First received: June 18, 2008
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

The purpose of the study is to evaluate the performance of the Discover cervical Artificial disc in the treatment of degenerative disc disease in one level of the cervical spine.


Condition Intervention Phase
Cervical Degenerative Disc Disease
Device: Arthroplasty (DISCOVER™)
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre, Prospective, Post Marketing Surveillance Study, Investigating the Performance of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease (DDD)

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Minimum of a 15 point improvement in Neck disability Index [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in visual analogue scale from pre-treatment [ Time Frame: over 5 years ] [ Designated as safety issue: No ]
  • Change in Quality of Life assessed by SF36 from pre-treatment [ Time Frame: over 5 years ] [ Designated as safety issue: No ]
  • Effect on sagittal angulation measured by radiographs [ Time Frame: Over 5 years ] [ Designated as safety issue: No ]
  • Effect on adjacent level degeneration measured by radiographs [ Time Frame: Over 5 years ] [ Designated as safety issue: No ]
  • Effect on maintenance of Disc height measured by radiographs [ Time Frame: Over 5 years ] [ Designated as safety issue: No ]
  • Effect on foraminal height measured by Radiographs [ Time Frame: Over 5 years ] [ Designated as safety issue: No ]
  • Effect on Cervical range of Motion measured by radiographs [ Time Frame: over 5 years ] [ Designated as safety issue: No ]
  • Incidence of device related adverse events [ Time Frame: Over 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: May 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
arthroplasty: Discover Device: Arthroplasty (DISCOVER™)
DISCOVER™ Artificial Cervical Disc
Other Name: DISCOVER™

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Orthopaedic patients

Criteria

Inclusion Criteria:

  • Male or female subjects, aged between 18 and 65 years inclusive.
  • Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
  • Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
  • Objective evidence of cervical disc disease in one vertebral level between C3-C7 defined as one or more of the following:

    • Shoulder and/or arm pain in a radicular distribution resulting from herniated disc or bony osteophytes (Consistent w diagnostic imaging including Axial CT, CT Myelogram, MRI and/or plain films)
    • Subjects with myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
  • Unresponsive to documented non-surgical management for ≥ 6 weeks and/or presents with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management (e.g., physical therapy, medication therapy, corticosteroid injections, etc.)
  • Minimum Neck Disability Index score of ≥30 % (15/50 points)

Exclusion Criteria:

  • Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
  • Subjects who are pregnant, lactating or wishes to become pregnant within the duration of the study.
  • Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  • Subjects who have participated in a clinical investigation with an investigational product in the last 30 days.
  • Subjects who are currently involved in any injury litigation claims.
  • Subjects with significant degeneration at more than one cervical level (e.g. DISH, ankylosing spondylitis, congenital abnormality, rheumatoid arthritis)
  • Subjects who have had any prior surgery at the level to be treated (subjects with a prior Laminotomy at the level to be treated may be included in the study)
  • Subjects who have marked cervical instability on lateral or flexion/extension x-rays defined as translation ³3mm and/or ³11 degrees of rotational difference to either adjacent level
  • Subjects who have presence of systemic infection or infection at the site of surgery
  • Subjects who have been diagnosed with malignancy
  • Subjects who have been diagnosed with a condition or require postoperative medication(s) that may interfere with bony/soft tissue healing
  • Subjects who have been diagnosed with Osteoporosis, Osteopenia, other metabolic bone disease or endocrine disorder known to affect osteogenesis.
  • Subjects with pre-existing neurological abnormalities other than deficits produced from the spinal lesion (e.g., MS, Parkinson's, CVA, diabetic neuropathy, peripheral neuropathy).
  • Subjects with morbid obesity defined as a BMI of ³40 or more than 100 lbs (45.4kg) over ideal weight.
  • Subjects with any known allergy to titanium metal, polyethylene, metal alloy or carbon fibre reinforced polymer
  • Subjects who have had prior fusion surgery at any level(s) (C1-T1)
  • Subjects with kyphosis >-15 degrees evaluated using the Cobb angle measurement
  • Subjects with Significant cervical degenerative disease characterized by bridging anterior osteophytes, significant loss of disc space height (3mm or less), sclerotic facets, large posterior osteophytes, autofusion of other cervical levels, and degenerative retrolisthesis. Spinal diseases such as DISH, ankylosing spondylitis, congenital abnormality, and rheumatoid arthritis, should also be excluded
  • Subjects undergoing treatment with a bone growth stimulator, which cannot be discontinued prior to enrollment in the study.
  • Significant kyphotic deformity or significant reversal of lordosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700739

Locations
Australia, New South Wales
Westmead Private Hospital
Sydney, New South Wales, Australia
Australia
Calvary Hospital
Tasmania, Australia
Germany
Klinikum Neustadt
Neustadt, Holstein, Germany
Italy
Divisione di Neurochirurgia
Rome, Italy
Malaysia
Island Hospital
Penang, Malaysia
Netherlands
Elisabeth Ziekenhuis
Tilburg, Netherlands
Spain
La Paz Hospital
Madrid, Spain
United Kingdom
Hope Hospital
Manchester, Lancashire, United Kingdom
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Henry Halm, Prof Klinikum Neustadt
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00700739     History of Changes
Other Study ID Numbers: CT0525
Study First Received: June 18, 2008
Last Updated: February 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by DePuy International:
Cervical
Disc
Arthroplasty
Spinal

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 20, 2014