Fusion or Not - a Study on Low Back Pain

NARecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2037

Conditions
Low Back Pain, MechanicalDegenerative Disc Disease Lumbar
Interventions
PROCEDURE

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."

PROCEDURE

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."

Trial Locations (4)

11433

RECRUITING

Ryggkirurgiskt centrum, Stockholm

75185

RECRUITING

Uppsala University, Uppsala

Unknown

RECRUITING

Sahlgrenska university hospital, Gothenburg

RECRUITING

Aleris Elisabetsjukhuset, Uppsala

All Listed Sponsors
collaborator

Uppsala University Hospital

OTHER

collaborator

Sahlgrenska University Hospital

OTHER

collaborator

Karolinska Institutet

OTHER

collaborator

University of Oslo

OTHER

collaborator

Aleris Hospital

OTHER

collaborator

Ryggkirurgiskt centrum, Stockholm

UNKNOWN

lead

Uppsala University

OTHER