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

NCT ID: NCT00700739

Last Updated: 2015-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-05-31

Brief Summary

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.

Detailed Description

The protocol underwent 3 amendments, the last of which (02APR2009) changed the study design from a randomized to a non-randomized and non-comparative clinical trial. All of the subjects were enrolled under the randomized design with the exception of the last subject. This study is not applicable per FDAA Title VIII, Section 801 due to the final trial design. However, results are submitted to clinicaltrials.gov due to the majority of study data being collected under a randomized (FDAA Title VIII, Section 801 applicable) trial design

Conditions

Cervical Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anterior Cervical Discectomy and Fusion (ACDF)

Anterior Cervical Discectomy and Fusion with Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft

Group Type: OTHER

ACDF

Intervention Type: DEVICE

Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft

Cervical Total Disc Replacement

DISCOVER™ Artificial Cervical Disc

Group Type: ACTIVE_COMPARATOR

DISCOVER™ Artificial Cervical Disc

Intervention Type: DEVICE

DISCOVER™ Artificial Cervical Disc

Interventions

DISCOVER™ Artificial Cervical Disc

DISCOVER™ Artificial Cervical Disc

Intervention Type: DEVICE

ACDF

Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft

Intervention Type: DEVICE

Eligibility 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 ≥3mm and/or ≥11 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 ≥40, 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Westmead Private Hospital

Sydney, New South Wales, Australia

Calvary Hospital

Tasmania, , Australia

Klinikum Neustadt

Neustadt, Holstein, Germany

Divisione di Neurochirurgia

Rome, , Italy

Island Hospital

George Town, , Malaysia

Elisabeth Ziekenhuis

Tilburg, , Netherlands

La Paz Hospital

Madrid, , Spain

Hope Hospital

Manchester, Lancashire, United Kingdom

Countries

Australia; Germany; Italy; Malaysia; Netherlands; Spain; United Kingdom

References

Salmons HI, Galetta MS, Divi SN, Fried TB, Fang T, Hoffman E, Goyal DKC, Mangan JJ, Schroeder GD, Vaccaro AR. Are Industry-funded Studies of Cervical Disc Arthroplasty Versus Anterior Cervical Discectomy and Fusion Biased? Clin Spine Surg. 2021 Feb 1;34(1):1-3. doi: 10.1097/BSD.0000000000000946. No abstract available.

Reference Type: DERIVED

PMID: 32049677 (View on PubMed)

Other Identifiers

CT 05/25

Identifier Type: -

Identifier Source: org_study_id