Randomised controlled clinical trial to evaluate osseos healing at titan-coated versus non-coated synthetic cages (PEEK)

Not Applicable

• Conditions: Degenerative diseases of the lumbar spine; M00-M99; Diseases of the musculoskeletal system and connective tissue

• Registration Number: DRKS00003321
• Lead Sponsor: Berufsgenossenschaftliche Unfallklinik Frankfurt,Zentrum für Wirbelsäülenchirurgie und Neurotraumatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Degenerative diseases of the lumbar spine (L1-S1) one or two sections affected

Exclusion Criteria

Systemic diseases (e.g. rheumatic spectrum disorder including Bechterews disease, infectious diseases including HIV, tumor diseases, etc.)-
Systemic intake of gulucocorticoides or immunosuppressants-
Postoperative regular intake of NSAID in the first 6 month-
Osteoporosis (T-Score < -2,5)-
Fracture-
Infection of the spine-
Previous operation of the lumbar spine excepting nucleotomy and decompression

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The introduced clinical trial shall analyse if the use of titanium coated PEEK cages brings advantages in terms of an early osseous incorporation and a higher fusion rate as opposed to a pure PEEK cage.<br>We will do an x-ray preOP, postOP and after 3, 6, and 12 month, also an CT after 6 and 12month. If the Fusion is not adequate at this point, an other CT will be done 24 month after surgery.<br>

Secondary Outcome Measures

Name	Time	Method
In contrast the clinical outcome and the complication rate should not be different if different PEEK cages are used.<br>These information will be registered with help of different questionnaires preOP, postOP and after 3, 6, and 12 month. We use VAS (Backpain), EQ-5D (measure of health status), Oswestry Disability Index (rating the severity of back pain) and Odoms Criteria (improvement of symptoms after surgery).