Treatment for Spinal Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Kansas Medical Center, Kansas City, KS
Spinal Diseases+1 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether irrigation with Irrisept can reduce the rate of surgical site infections in spinal fusion procedures.

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Eligible Conditions

  • Spinal Diseases
  • Lumbar Spine Disease

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 2 secondary outcomes in patients with Spinal Diseases. Measurement will happen over the course of assessed for change at 12 months.

assessed at 12 months
Patient outcome measures
Month 12
Fusion rates after surgery
Postoperative surgical site infections

Trial Safety

Trial Design

2 Treatment Groups

Irrisept irrigation solution
1 of 2
normal saline control arm
1 of 2
Active Control
Non-Treatment Group

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Irrisept irrigation solution
Device
ii. Irrigation (Irrisept vs control of normal saline) used after initial skin inicision prior to coming through fascia, after placement of instrumentation (screws, hooks), prior to placement of bone graft, and after fascial closure iii. Irrigation exposure/soak time to be 1 min for each irrigation time point. iv. 1 bottle (450 mL) Irrisept irrigation to be used during case with normal saline rinse to follow at each irrigation time point in study subjects
normal saline control arm
Device
ii. normal saline used after initial skin incision prior to coming through fascia, after placement of instrumentation (screws, hooks), prior to placement of bone graft, and after fascial closure iii. Irrigation exposure/soak time to be 1 min for each irrigation time point.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed for change at 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly assessed for change at 12 months for reporting.

Closest Location

The University of Kansas Medical Center - Kansas City, KS

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18-85, undergoing primary lumbar spinal fusion (less than or equal to 3 levels)

Patient Q&A Section

How many people get spinal diseases a year in the United States?

"About 1.4 million of US children receive a spinal diagnosis each year. This translates to around 3.9 new cases/100,000 children/year. This means that 0.04% of all children and 0.18% of all adolescents will develop a spinal disease in their lifetime. It is important to recognize the potential impact of spinal diseases on children and adolescents as they grow older." - Anonymous Online Contributor

Unverified Answer

What is spinal diseases?

"This topic emphasizes the need for a continuous process of education and instruction, both within and outside the field of musculoskeletal medicine. Furthermore, it presents the opportunity to bring together key experts and health professionals in a variety of different facets and specialties within the field of medicine. This initiative provides an opportunity to disseminate knowledge and knowledge based on a variety of perspectives to address issues related to spain, Europe and world health in general." - Anonymous Online Contributor

Unverified Answer

Can spinal diseases be cured?

"There is a significant difference between surgical and conservative treatment of spinal degenerative diseases. However, spinal surgery cannot totally or temporarily stop the process of disc degeneration or repair spinal cord, and the only way to halt further disease progression is complete discontinuation of oral and illegal drugs." - Anonymous Online Contributor

Unverified Answer

What are common treatments for spinal diseases?

"A wide variety of procedures are used in the care of patients with spinal diseases. For some patients, surgery may not be possible or appropriate. If surgery to correct spinal disease is thought appropriate the decision will be highly dependent on the severity and prognosis for the individual patient. The treatments may include physical therapy to improve strength and coordination, braces to stabilize the spine, orthopaedics to improve posture, injections to control pain or improve bone and cartilage structure, chiropractic to relieve joint pain or for functional reasons or surgery (especially degenerative spinal diseases). Treatments are highly individualised and are tailored to the specific patient." - Anonymous Online Contributor

Unverified Answer

What causes spinal diseases?

"In a recent study, findings demonstrates a significant association between employment on the unoccupied time of the employees and their subsequent development of lumbosacral plexus disorders. It is difficult to explain a possible causal link by the occupational exposure. However, further studies are needed in order to confirm these findings." - Anonymous Online Contributor

Unverified Answer

What are the signs of spinal diseases?

"Abnormal neurological examinations may include reduced sensation, loss of muscle tone, loss of deep tendon reflexes and loss of lower limb sensation. A spinal nerve root lesion can cause weakness of voluntary muscles of the lower extremities. Cervical spine MRI can be helpful to evaluate the spinal cord and spinal nerves for soft tissue impingement. X-rays, CT scan and MR scans of the neck are helpful to evaluate the carots, jugulars, pharyngeal arches and clavicles for osteoporosis, degenerative pathology and fractures." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of spinal diseases?

"The primary cause of spinal diseases seems to be compression due to spinal malverdure. The compression is due to various factors like trauma resulting in disc herniation. Spinal stenosis is an important problem. The decompression is a primary method in spinal surgery. Therefore, decompression surgery should be performed as a primary intervention. The spinal surgery done in our series seems to be helpful." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving treatment?

"Recent findings of this study suggest that no previous studies have been conducted with regard to treatment options for ILD. The small sample size is a limitation which requires consideration when choosing clinical trials. The studies listed here may have had positive outcomes, but no conclusions can be drawn from these publications." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"Treatment is based on the needs of the patient as well as on the needs of the doctor and family. There is no single treatment for Chédiak-Higashi syndrome and current treatment should be based on clinical diagnosis. Treatment is more successful if it is carried out in a multidisciplinary team." - Anonymous Online Contributor

Unverified Answer

Does spinal diseases run in families?

"Considering the increased awareness of this condition lately, it will be crucial to discover the genetic and environmental factors that are associated with the onset of vertebral fusion and instability in children with ankylosing stenosis. However, although some possible genes have been discovered that could be implicated in the development of spondylosis, their exact mechanisms of action are not fully known. Therefore we are only able to speculate on the role of the gene in the development of spondylosis." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with spinal diseases?

"The survey found that patients who were receiving standard of care reported worse pain, function, and satisfaction compared to those who did not receive treatment. Additionally, patients who received treatment reported more improvement in their spinal conditions compared to the same patients receiving standard of care." - Anonymous Online Contributor

Unverified Answer

How serious can spinal diseases be?

"The most common presenting complaint of patients with [back pain](https://www.withpower.com/clinical-trials/back-pain) is sciatica, which occurs in the presence of spinal root pain in 50% of cases. A positive sciatica physical examination can be predictive for spondylopathies, since cervical, thoracic or lumbar radiculopathy and myelopathy can be expected if there is a positive exam, especially in those under the age of 50." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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