Vertebropexy - Randomized-controlled Trial (VPRCT)
Degeneration, Spinal Stenosis, Fusion of Spine
About this trial
This is an interventional treatment trial for Degeneration focused on measuring degenerative lumbar spinal disease, decompression, fusion, vertebropexy, ligamentous fixation
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Single-level or two-level lumbar surgery Indication for decompression surgery in patients with spinal canal stenosis and additional stable degenerative listhesis (without facet joint effusion ≥ 2mm) Indication for fusion surgery in patients with spinal canal stenosis and additional unstable degenerative listhesis (facet joint effusion ≥ 2mm), in patients with foraminal stenosis and additional degenerative listhesis, and in patients with segment degeneration of the disc Understanding in German language Exclusion Criteria: Indication for decompression and/or fusion surgery in patients with solely disc herniation, fractures, lytic listhesis, tumor Patients undergoing revision surgery for infection Patients undergoing revision surgery on the same level if bony structures have been removed (e.g. prior laminectomy or midline decompression) Patients undergoing revision surgery in case of prior fusion surgery Surgery on level L5/S1 Inability to understand the study for linguistic or cognitive reasons Anticipated clinical follow-up of less than 6 weeks after inclusion Participation in other clinical trials
Sites / Locations
- Balgrist University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Active Comparator
Experimental
Indication for decompression, randomization for decompression
Indication for decompression, randomization for vertebropexy
Indication for fusion, randomization for fusoin
Indication for fusion, randomization for vertebropexy
microsurgical lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures; approach: bilateral or ipsilateral with cross-over to the contralateral side
decompression (see above) and additional stabilization of the spine with a biological ligament (for instance semitendinosus donor allograft), which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.
decompression and posterolateral instrumented fusion (arthrodesis) with implantation of pedicle screws, titanium alloy rods across the level of listhesis, an intervertebral fusion device and local autograft as well as DBX (demineralized bone matrix) to improve bony fusion
decompression (see above) and additional stabilization of the spine with a biological ligament (for instance semitendinosus donor allograft), which will be pulled through a drilled hole in the spinous process of two adjacent vertebra in a looping technique and tendon ends fixed by an anchor knot after baseball stitches in a standardized fashion. Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia). Passive stability in clinically important directions of motion such as flexion-extension and shear movements will be provided, yet without stiffening other directions of motion.