Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Universitätsmedizin Mannheim
- Enrollment
- 88
- Primary Endpoint
- Clinical outcome (NDI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Clinical outcome (NDI)
Time Frame: 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 Outcomes
- Clinical outcome (VAS-neck), Subsidence(12 months postoperative)
Investigators
Martin Barth, MD
M. D., Vice-chairman
Universitätsmedizin Mannheim