Total Disc Replacement Versus Anterior Cervical Decompression and Fusion

NCT02417272 | Completed

• 1 other identifier: CHUBX 2010/40
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 3

Brief Summary

Background : Cervical degenerative disc disease is frequent and the consequence of aging. Degeneration may lead to disc herniation. Surgery is indicated in the presence of root compression with cervicobrachial neuralgia and/or myelopathy. Purpose: The main objective of the study is the comparison of efficacy between total disc replacement (TDR) and Anterior Cervical Decompression and Fusion (ACDF) as surgical treatment of symptomatic cervical degenerative disc disease in term of "Success" rate, defined as preservation of adjacent segments, 24 months after surgery. In our knowledge, there are no published data about randomized clinical trials comparing these radiological parameters (worsening of degeneration signs on static cervical spine radiographs and worsening of disc degeneration signs on MRI) at levels adjacent to surgery, between these 2 surgical approaches in patients suffering from cervical degenerative disc disease.

Conditions

Cervical Degenerative Disc Disease

Keywords

Total Disc Replacement; Anterior Cervical Decompression and Fusion

Outcome Measures

Primary Outcomes (1)

• To compare efficacy of TDR and ACDF as surgical treatment of cervical degenerative disc disease in term of "success rate" defined as absence of radiological degenerative disease at adjacent levels

  24 months after surgery

Secondary Outcomes (2)

• Between-group comparison of tolerance

  24 months after surgery

• Between-group comparison of efficacy

  45 days, 6, 12 and 24 months after surgery

Study Arms (2)

Total disc replacement (TDR)

EXPERIMENTAL

Total disc replacement with preserved segmental motion decreasing load on adjacent levels.

Device: Surgical treatment of cervical degenerative disc disease (CP ESP®)

Anterior Cervical Decompression and Fusion (ACDF)

EXPERIMENTAL

Interbody fusion by replacing disc space with a cage packed with bone substitute, and inserted into the anterior portion of the interspace.

Device: Surgical treatment of cervical degenerative disc disease (Axelle®)

Interventions

Surgical treatment of cervical degenerative disc disease (CP ESP®) DEVICE

Total disc replacement (TDR)

Surgical treatment of cervical degenerative disc disease (Axelle®) DEVICE

Axelle®

Anterior Cervical Decompression and Fusion (ACDF)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-60 years
• suffering from cervical disc degenerative disease (whatever the grade, level and intervertebral disc height) needing one-level surgical treatment due to either invalidating cervicobrachial nevralgia despite 3-month optimal medical treatment or neurological symptoms, with motion of surgical level at least equal to 2° degrees, and non-degenerative adjacent discs.
• Being affiliated to health insurance

You may not qualify if:

• Previous cervical traumatism and/or cervical surgery.
• Cervical degeneration defined as a Grade 4 according to modified Mehren classification and/or a Grade 5 according to Miyazaki et al classification on T2 magnetic resonance imaging (MRI), at symptomatic level and/or its adjacent levels.
• Myelopathy.
• Cervical spine instability.
• Presence of at least one major contraindication to surgery and/or general anaesthesia (ie, non-controlled coagulopathy, active infection, or serious underlying disease, auto-immune affection).
• Presence of at least one contraindication to either TDR or ACDF procedure.
• Presence of at least one contraindication to either static/dynamic radiographs or Magnetic Resonance Imaging (MRI).
• Severe radiological osteoporosis.
• Bone metabolic disease.
• Chronic intake of corticosteroids or any other treatment susceptible to interfere with study conduct and/or assessment (ie, immunosuppressive drugs).
• Unlikely to comply with the requirements of the study and/or to complete the study for psychological, social, familial or geographical reasons.
• No contraception for women of childbearing age
• Pregnant or breastfeeding women
• Being under guardianship or legal supervision.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ministry for Health and Solidarity, France: collaborator

Study Sites (3)

Chirurgie Orthopedique

Bordeaux, 33076, France

Location

CHU Nice - Unité de Chirurgie Rachidienne

Nice, 06000, France

Location

Chirurgie Orthopedique

Paris, 75013, France

Location

Study Officials

• Antoine BENARD, MD

  University Hospital Bordeaux, France

  STUDY CHAIR

• Olivier GILLE, Prof

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: April 15, 2015
• Study Start: November 4, 2015
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

FR (3)