Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine (Topping-off)

University of Cologne

Status: Unknown

Conditions: Spondylolisthesis; Erosive Osteochondrosis in L2-S1

Treatments: Device: Topping off system; Device: monosegmental PLIF

Study type: Interventional

Funder types: Other

Identifiers

NCT01224379

Uni-Köln-1223 (Other Grant/Funding Number)

Details and patient eligibility

About

Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?

Full description

Primary efficacy endpoint:

The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).

Key secondary endpoint(s):

1. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36
2. Individual dimensions of the Oswestry Disability Index (ODI)
3. Time until radiological adjacent instability and comparison to the clinical outcome
4. Capacity of work at the time of surgery and after surgery, time until return to work

Assessment of safety:

1. Treatment complication in control and intervention groups (SAE-management)
2. A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias

Enrollment: 30 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

1. Male or female >30 years of age
2. Lumbar spine pathology with indication for monosegmental PLIF
3. Radiological signs of a degeneration of the adjacent segment without instability

Key exclusion criteria:

1. Radiological signs of existing instability of the adjacent segment 2. Normal endplates and no disc desiccation in MRI in the adjacent seg-ment 3. Previous surgery of the lumbar spine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Arm1: "topping off" system

Other group

Description:

The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).

Treatment:

Device: Topping off system

Arm 2: monosegmental PLIF

Other group

Description:

The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)

Treatment:

Device: monosegmental PLIF