Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking

NCT00949936 | Completed

• 1 other identifier: Ranier01/2008
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 4

Brief Summary

The purpose of this European Union (EU) study to evaluate the safety and performance of the CAdiscTM-L Lumbar Spinal Disc Replacement Device in the surgical replacement of the lumbar intervertebral discs (L3 to S1) for patients requiring surgical intervention for total lumbar disc replacement for the treatment of debilitating, chronic low back pain.

Conditions

Chronic Low Back Pain; Lumbar Degenerative Disc Disease

Keywords

Spine surgery

Outcome Measures

Primary Outcomes (1)

• Improvement of 15 points on the Oswestry Disability Index (ODI) scale at 3 months post-surgery, compared to baseline

Interventions

CAdisc™-L (Total Disc Replacement) DEVICE

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non pregnant, non-lactating female
• Aged between 25-65 years (inclusive)
• BMI \< 35
• Preoperative ODI \> 30 points
• Chronic low back pain, and is in the opinion of the investigator a suitable candidate for anterior lumbar surgery
• Completed at least 6 months of conservative treatment without obtaining adequate symptomatic relief
• Degenerative disc changes at a single level between L3 - L4, or L4 - L5, or L5 - S1 as confirmed by positive discography and visualized by X-Ray, CT or MRI scan and/or with one or more of the following:
• Decrease in disc height \< 50% (or up to 80% and no benefit from facet injections)
• Annular thickening
• Herniated nucleus pulpous
• Subject is able to give voluntary, written informed consent to participate in this investigation and from whom written consent must be obtained prior to enrolment.

You may not qualify if:

• Back or leg pain of unknown aetiology
• Radicular or sciatic pain which is more severe than low back pain
• Previous lumbar spinal surgery which could affect the trial outcome (e.g., disc replacement)
• Obvious signs of psychological or worker's compensation or litigation claim elements to their condition, or are actively engaged in such activities
• Subject is unwilling or unable to give consent or adhere to the follow-up programme
• Active infection or metastatic disease
• Non-degenerative spondylolisthesis
• Degenerative spondylolisthesis \> grade 1
• Known allergy to any of the implant materials
• Osteoporosis (if suspected to be confirmed by bone density being 2.5SD below normal as assessed using DEXA analysis in post-menopausal females if suggested by X-ray or other risk factors)
• Osteopenia
• Bony lumbar stenosis
• Pars defect
• Isolated radicular compression syndromes, especially due to disc herniation
• Clinically compromised vertebral bodies at the affected levels due to current or past trauma

Sponsors & Collaborators

• Ranier Technology Limited: lead

Study Sites (4)

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Bogen, Germany

Location

Unknown Facility

Zwolle, Netherlands

Location

Unknown Facility

Aberdeen, United Kingdom

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Total Disc Replacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: July 31, 2009
• Study Start: October 1, 2009
• Study Completion: June 1, 2010
• Last Updated: October 15, 2010

Record last verified: 2010-10

Locations

BE (1); NL (1); GB (1); DE (1)