In-house Produced PMMA- Versus PEEK-cages

Cervical Disc Degeneration Clinical Trial

— Palcage  

Official title:

Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607775
• Other study ID #: 2007-256M-MA
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 22, 2012
• Last updated: June 4, 2012
• Start date: February 2009
• Est. completion date: February 2012

Study information

• Verified date: June 2012
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Degeneration
• Cervical Stenosis
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

Device:
• Implantation of a PEEK-cage
A commercially avaliable cuboid cervical cage will be implantet
• PMMA-cage
The in-house produced cervical cage will be implanted

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome (NDI)	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).	12 months postoperative
Secondary	Clinical outcome (VAS-neck), Subsidence	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).; 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).	12 months postoperative