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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003321

Enrollment

Registered

2011-12-14

Start date

2010-10-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative diseases of the lumbar spine M00-M99

Interventions

Group 1: posterior lumbal interbody fusion - poly-ether-ether-ketone cages with titan alloy Group 2: posterior lumbal interbody fusion - poly-ether-ether-ketone cages

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Secondary

Measure	Time frame
In contrast the clinical outcome and the complication rate should not be different if different PEEK cages are used. 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).	—

Measure

Time frame

In contrast the clinical outcome and the complication rate should not be different if different PEEK cages are used. 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).

—

Countries

Germany

Contacts

Public ContactSarah Winkelkotte

Berufsgenossenschaftliche Unfallklinik Frankfurt, Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie

Sarah.Winkelkotte@BGU-Frankfurt.de069 475 2914

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026