uNEC™ disc prosthesis versus Prestige® artificial cervical disc replacement: a pilot study

Completed

• Conditions: Cervical disc degeneration; Cervical disc disorders; Musculoskeletal Diseases

• Registration Number: ISRCTN63878911
• Lead Sponsor: orth Tees and Hartlepool NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-14
• Study Completion: 2016-05-01
• Last Update Posted: 2 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Single, double or multi-level cervical degenerative disc disease in any age group and sex
2. Failed conservative treatment which includes reduction of activities, physical therapy and anti-inflammatory medications
3. Acute severe grade motor or sensory deficit
4. Cervical radiculopathy - neck arthritis (wear and tear in the neck) causing arm pain because of pressure on nerves
5. Cervical myelopathy - neck arthritis causing arm pain and coordination problem because of pressure on spine or the nerves coming out of spine
6. Combination of cervical radiculopathy and myelopathy symptoms
7. Hard and soft disc pathology

Exclusion Criteria

1. Participants unable to consent for the trial
2. Patients not willing to take part in the study
3. Patients participating in other clinical trials
4. Patients with previous surgery involving neck excluding injections
5. Severe facet joint arthritis involving cervical spine
6. History of discitis at the same level of surgery
7. Cervical instability: sagittal-plane translation greater than 3.5 mm, or sagittal plane angulation grater than 20 degrees at a single level
8. Lack of movement at the disc level

Study & Design

• Study Type: Interventional
• Study Design: Not specified