90
Participants
Start Date
February 1, 2025
Primary Completion Date
December 31, 2030
Study Completion Date
December 31, 2037
Fusion surgery
"After anaesthesia, the surgical area is identified through intraoperative fluoroscopy. After sterile draping, incision is made through skin and subcutaneous fat. Dissection is performed bilaterally down to the facet joints and transverse processes. Intraoperative fluoroscopy or computed tomography is performed to verify the surgical level. When the dissection is complete, randomization takes place.~Randomization to fusion (active treatment):~Pedicle screws are placed. Interbody cages may be used. Fluoroscopy or intraoperative computed tomography with or without intraoperative navigation is performed for correct implant positioning. Decortication is performed in the surgical area, and the cartilage in the facet joints is partially removed to allow fusion. Local bone graft is used and placed in the surgical area. Rods are placed in the screws and the fixation system is locked. Local anaesthesia is given in the surgical area. Fascia, subcutaneous tissue, and skin is sutured."
Non-fusion surgery
"After anaesthesia, the surgical area is identified through intraoperative fluoroscopy. After sterile draping, incision is made through skin and subcutaneous fat. Dissection is performed bilaterally down to the facet joints and transverse processes. Intraoperative fluoroscopy or computed tomography is performed to verify the surgical level. When the dissection is complete, randomization takes place.~Randomization to non-fusion surgery (control):~No implants are placed. No decortication is performed. The facet joints are left intact. Local anaesthesia is given in the surgical area. Fascia, subcutaneous tissue and skin is sutured."
RECRUITING
Ryggkirurgiskt centrum, Stockholm
RECRUITING
Uppsala University, Uppsala
RECRUITING
Sahlgrenska university hospital, Gothenburg
RECRUITING
Aleris Elisabetsjukhuset, Uppsala
Uppsala University Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Karolinska Institutet
OTHER
University of Oslo
OTHER
Aleris Hospital
OTHER
Ryggkirurgiskt centrum, Stockholm
UNKNOWN
Uppsala University
OTHER