View clinical trials related to Spinal Fusion.
Filter by:This 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
Bone marrow aspirate (BMA) in association to graft substitutes has long been introduced as a promising alternative to iliac crest bone graft in spinal fusion. However, BMA use is limited by the absence of a standardized technique, of a physical texture and by the possibility of dispersion away from the implant site. Recently, the potential use of a new formulation of BMA, named BMA clot, has been preclinically described. A prospective pilot clinical study designed to assessing the safety and efficacy of autologous vertebral BMA (vBMA) clot as multifunctional bio-scaffold in instrumental posterior lumbar fusion will be performed.
Elective spine surgery is associated with a high incidence of perioperative complications, including peri- and postoperative pulmonary complications (PPCs), which occur in nearly 4% of patients. More than 40% of all deaths after elective spine surgery are attributed to PPCs. However, whether it influences risk of other PPCs is unclear.
In recent years, it is known that the use of complementary approaches, which are accepted as a safe and effective method for maintaining health and well-being, providing relaxation/relaxation, and reducing the effects of illness, has been increasing. It is reported that massage, which originates from an instinctive need for touch and is one of the oldest treatment methods, was first described in China in the second century BC and immediately after in India and Egypt, and was widely used by other early cultures such as Arabs, Greeks, Italians and Romans. In papyruses, on rocks, and in ancient oral stories dating back 15,000 years, there is evidence of the use of hands to provide comfort and healing. It is stated that foot massage, which is one of the most frequently used massage types today, has been applied in different parts of the world such as Egypt, India and China for thousands of years. In addition to pharmacological methods, non-pharmacological complementary and alternative treatment methods are also used in the control of pain due to reasons such as dissatisfaction with traditional treatment methods, reluctance to use invasive procedures and daily analgesics, and the toxic effects of drugs. Massage provides relaxation both physically and mentally. It is thought to reduce edema by accelerating circulation, muscle tension and anxiety by the stimuli reaching the spinal cord, and pain sensation by stimulating peripheral sensory receptors.
Rationale: 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.
The objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: Patient green (success) orange (treatment failure ), red patient (complication) in order to optimize his medical care up to 6 months.
The process of bony fusion is a dynamic bone remodeling process and a variety of risk factors have been identified to contribute to pseudoarthrosis.Vitamin D deficiency has been reported to be associated with more pseudoarthrosis, prolonged time to fusion, and poorer spine function and quality of life after spinal fusion.However, as the review article presented, it lacks high-quality evidence to investigate the role of vitamin D supplements in spinal fusion. Therefore, this randomized controlled trial aimed to evaluate the effectiveness of oral vitamin D supplements on fusion outcomes in patients receiving elective lumbar spinal fusion.
The aim of this of study is to identify the incidence of mechanical failures after spinal fusion within one year of surgery and to assess the related risk factors.
This Controlled Randomized Clinical Trial aimed at determining the effectiveness of a modified RR intervention in reducing post-operative pain and psychological symptoms in patients undergoing surgery intervention. Researches hypothesized that compared to controls patients undergoing modified RR intervention were characterized by 1. improved capability to discriminate emotions from bodily feelings; 2. reduce emotional distress; 3. reduced pain perception. Moreover, researches hypothesized that (4) these effects were maintained over time.
The acute pain after spinal surgery is serious. The most pain is during 24 hours after surgery. The multimodal therapy is a method which is applied to treat the postoperative pain. Morphine is main analgesic to treat postoperative pain. However, some the side-effects can occur to patients and there are associate with dosage. So, some analgesics usually combinate with morphine to postoperative analgesia, include gabapentin, celecoxib, ketamine, ... Nefopam is a central analgesic. There are effect prevent hyperalgesia. The effect of the combination of gabapentin with nefopam to postoperative analgesia in spinal surgery hasn't been reported yet. The gabapentin oral with 600 mg combine with continuously intravenous nefopam with 65 µg/kg/hour during 24 hours after spinal surgery whether to increase the effect of postoperative analgesia. The investigators hypothesized that the gabapentin oral with 600 mg combine with continuously intravenous nefopam with 65 µg/kg/hour during 24 hours after spinal surgery can decrease 40% of the consumption of morphine during 24 hours.