Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures
Cervical StenosisSpondylolisthesis2 moreThe primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.
Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery
Juvenile; ScoliosisScoliosis Idiopathic4 moreThis is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).
Lumbar Fusion With Porous Versus Non-Porous Cages
Spinal FusionLumbar Fusion3 moreThe objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions: Porous titanium cages Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.
Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery
SpondylolisthesisLumbar Disc Herniation9 moreRationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use, despite use of multimodal analgesia. The erector spinae plane block (ESPB) is a promising locoregional anesthetic technique for this type of surgery. The literature is not yet conclusive about the effectiveness of this technique on reducing postoperative pain intensity. Objective: The objective of this study is to evaluate the analgesic effect of ESPB as add-on therapy to multimodal analgesia on early postoperative pain intensity after lumbar spinal fusion surgery compared to placebo. Study design: The study is designed as a prospective mono-centre, randomized, double-blinded, placebo-controlled trial. Study population: 76 patients ≥ 18 years of age requiring elective lumbar spinal fusion surgery involving one to four fusion levels. Intervention: Patients will receive ultrasound-guided ESPB with either ropivacaine or placebo at the end of surgery. Main study parameters/endpoints: Main study parameter is pain intensity upon emergence from anesthesia measured with the Numeric Rating Scale. A minimal clinically important difference is considered to be a decrease of 1.5 points. Secondary endpoints are pain intensity during hospital stay and after 30 days, opioid use during hospital stay and after 30 days, opioid side effects, use of anti-emetics, time to first opioid use/request, length of hospital stay, quality of recovery at discharge. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Sint Maartenskliniek is experienced in applying locoregional analgesia, the use of ropivacaine and using sonography. The procedure of administering ESPB has a very low risk of complications. Receiving placebo is justifiable because this group will not be withhold standard treatment. The risks of receiving placebo are negligible. The patients will visit the clinic at regular follow-up moments.
Clinical Decision-Making and Virtual Reality Exercise
Degenerative Lumbar Spinal StenosisDegenerative Disc Disease2 moreDegenerative lumbar spine disease (DLSD) is common in elderly individuals and can result in pain, muscle weakness, and paresthesia. Numerous studies have reported that patients with DLSD usually have postural balance instability, which may affect the patient's gait, functional activities, and quality of life. The investigators propose to achieve the following aims: (1) to develop a clinical balance diagnostic tool to identify patients with DLSD who may require lumbar surgery (2) to investigate the effects of virtual reality skateboard exercise training on gait and balance in patients with DLSD.
Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial...
Lumbar Spine DegenerationLumbar Spine Instability2 moreSymptomatic lumbar spinal stenosis is the most common indication for spinal surgery. However, more than one-third of the patients undergoing surgery for lumbar stenosis report dissatisfaction with the results. On the other hand, conservative treatment has shown positive results in some cases. This trial will compare the outcomes of surgical versus non-surgical treatment for lumbar stenosis.
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection...
Spinal FusionSpinal Stenosis1 moreDeep surgical site infection (DSSI) is one of the most challenging complications for spinal surgeons and can lead to a poor clinical outcome. This ambispective study was designed to examine the effect of vancomycin powder mixed with autogenous bone graft and bone substitute on preventing deep surgical site infection (DSSI) in degenerative lumbar fusion surgeries as well as any interference with bony fusion.
PREventing Pain After Surgery
PainBack5 moreThe present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.
Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2...
SpondylosisSpondylolisthesis1 moreThe aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in standalone ALIF procedure L5/S1
Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion
Enhanced Recovery After SurgerySpinal Fusion2 moreThis study is a randomized controlled non-inferiority trial designed to evaluate the impact of implementing the 'Early Recovery After Surgery Clinical Pathway (ERAS CP)' on patient-reported pain levels at the time of discharge following Oblique Lumbar Interbody Fusion (OLIF) surgery