Clinical Trial: Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Spacer Squale (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary: This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc devices (prosthesis vs rigid spacer) with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.

Detailed Summary:
Sponsor: Technische Universität Dresden

Current Primary Outcome: Change in Neck disability index compared to baseline [ Time Frame: 6 weeks, 3, 6, 12 and 24 months postoperative ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline [ Time Frame: 6 weeks, 3, 6, 12 and 24 months postoperative ]
  • Change in EuroQOL (EQ-5D) compared to baseline [ Time Frame: 6 weeks, 3, 6, 12 and 24 months postoperative ]
  • Change in Core Outcome Measure Index (COMI) compared to baseline [ Time Frame: 6 weeks, 3, 6, 12 and 24 months postoperative ]
  • Change in flexion and extension radiographs compared to baseline (angle difference [deg]). [ Time Frame: 6 weeks, 3, 6 and 12 months postoperative ]
  • Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline (distance difference [mm]) [ Time Frame: 6 weeks, 3, 6 and 12 months postoperative ]
  • Change in consumption of analgetics compared to baseline [ Time Frame: 6 weeks, 3, 6, 12 and 24 months postoperative ]
    The change in analgetics consumption will be assessed on a scale of increase - stable - reduction.
  • Return to work [ Time Frame: 6 weeks postoperative ]
  • Return to work [ Time Frame: 3 months postoperative ]
  • Return to work [ Time Frame: 6 months postoperative ]
  • Return to work [ Time Frame: 12 months postoperative ]
  • Return to work [ Time Frame: 24 months postoperative ]
  • Mortality [ Time Frame: 6 weeks postoperative ]
  • Mortality [ Time Frame: 3 months postoperative ]
  • Mortality [ Time Frame: 6 months postoperative ]
  • Mortality [ Time Frame: 12 months postoperative ]
  • Mortality [ Time Frame: 24 months postoperative ]
  • Adverse effects [ Time Frame: 6 weeks postoperative ]
  • Adverse effects [ Time Frame: 3 months postoperative ]
  • Adverse effects [ Time Frame: 6 months postoperative ]
  • Adverse effects [ Time Frame: 12 months postoperative ]
  • Adverse effects [ Time Frame: 24 months postoperative ]


Original Secondary Outcome: Same as current

Information By: Technische Universität Dresden

Dates:
Date Received: October 13, 2016
Date Started: June 2016
Date Completion: June 2019
Last Updated: October 14, 2016
Last Verified: October 2016