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

NCT00700739 | Terminated Phase 4 Results DMC

• 1 other identifier: CT 05/25
• Study Type: interventional
• Target: 60
• Locations: 7 countries
• Sites: 8

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.

Conditions

Cervical Degenerative Disc Disease

Keywords

Cervical; Disc; Arthroplasty; Spinal

Outcome Measures

Primary Outcomes (1)

• Overall Patient Success

  Overall success was a composite endpoint determined by the following clinical outcome measures: 1. Neck Disability Index ≥ 15-point improvement from baseline to 12 months post-operative, 2. No new clinically significant permanent abnormalities in neurological function (i.e. motor strength, nerve root tension signs, sensory and reflex signs) from baseline to 12 months post-operative, 3. No subsequent secondary surgical interventions (SSI) at the index level, and 4. No device-related serious events (dSAE) from intra-operative through 12-months post-operative. Please note that these time periods were intended to be from baseline to 24 months post-operative, but since the study was terminated early the 12 month time periods were utilized.

  12 months

Secondary Outcomes (15)

• Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months

  12 months

• Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months.

  12 Months

• Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months.

  12 Months

• Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months.

  12 Months

• Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months.

  12 Months

Study Arms (2)

Anterior Cervical Discectomy and Fusion (ACDF)

OTHER

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

Device: ACDF

Cervical Total Disc Replacement

ACTIVE COMPARATOR

DISCOVER™ Artificial Cervical Disc

Device: DISCOVER™ Artificial Cervical Disc

Interventions

DISCOVER™ Artificial Cervical Disc DEVICE

DISCOVER™ Artificial Cervical Disc

Cervical Total Disc Replacement

ACDF DEVICE

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

Anterior Cervical Discectomy and Fusion (ACDF)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• DePuy International: lead

Study Sites (8)

Westmead Private Hospital

Sydney, New South Wales, Australia

Location

Calvary Hospital

Tasmania, Australia

Location

Klinikum Neustadt

Neustadt, Holstein, Germany

Location

Divisione di Neurochirurgia

Rome, Italy

Location

Island Hospital

George Town, Malaysia

Location

Elisabeth Ziekenhuis

Tilburg, Netherlands

Location

La Paz Hospital

Madrid, Spain

Location

Hope Hospital

Manchester, Lancashire, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32049677 DERIVED

Limitations and Caveats

Study was terminated early therefore the latest clinical data available is at the 12 month post-operative timepoint and the latest radiographic data available is at the 6 month post-operative timepoint.

Results Point of Contact

• Title: Mark Lotito
• Organization: DePuy Synthes Spine

Mlotito@its.jnj.com

(508) 880-8045

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 21, 2015
• Results First Posted: August 10, 2015

Record last verified: 2015-09

Locations

IT (1); AU (2); DE (1); NL (1); ES (1); MY (1); GB (1)