In-house Produced PMMA- Versus PEEK-cages

Phase 1

Completed

• Conditions: Cervical Disc Degeneration; Cervical Stenosis
• Interventions: Device: Implantation of a PEEK-cage; Device: PMMA-cage

• Registration Number: NCT01607775
• Lead Sponsor: Universitätsmedizin Mannheim

Brief Summary

Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. As control, a commercially available PEEK-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. The investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-05-22
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-30
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• virgin spines
• no emergency operation
• age above 18
• sufficient knowledge of the German language
• indication for anterior cervical discectomy and fusion
• absence of concomitant spinal disease

Exclusion Criteria

• prior cervical surgery
• indications other than ACDF
• concomitant neoplastic, metabolic, severe general or infectious disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEEK-cage	Implantation of a PEEK-cage	Patients will receive a PEEK-cage
PMMA-cage	PMMA-cage	-

Primary Outcome Measures

Name	Time	Method
Clinical outcome (NDI)	12 months postoperative	NDI (Neck disability index) will be measured prior to surgery and 12 months after surgery. A difference of 20% between both groups is considered to be clinically significant, which is proposed for the experimental implant (PMMA-cage).

Secondary Outcome Measures

Name	Time	Method
Clinical outcome (VAS-neck), Subsidence	12 months postoperative	1. VAS-neck will be measured prior to surgery and 12 months after surgery. A difference of 20% between both groups is considered to be clinically significant, which is proposed for the experimental implant (PMMA-cage).; 2. Cage Subsidence will be measured using lateral radiographs prior to surgery and 12 months after surgery. Due to an improved cage design, significantly less subsidence is proposed for the experimental implant (PMMA-cage).