Treatment for Surgical Procedure, Unspecified

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sinai Hospital of Baltimore, Baltimore, MD
Surgical Procedure, Unspecified
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 3 primary outcomes and 4 secondary outcomes in patients with Surgical Procedure, Unspecified. Measurement will happen over the course of at the 2 week visit.

1 year post-operation
To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)
Year 1
To assess change in disability using the Oswestry Disability Index (ODI)
To assess change in quality of life using the Health and Quality of life improvement (SF-36)
Month 6
To assess change in surgical and post-operative outcomes (function) of two standard of care cohorts: autograft versus allograft (ClearFit)
To assess change the surgical and post-operative outcomes (function) of two standard of care cohorts: autograft versus allograft (ClearFit)
Year 1
To assess change in pain using the Visual Analogue Scale (VAS) Pain scale
Week 2
To assess overall patient satisfaction of two standard of care cohorts: autograft versus allograft (ClearFit)Patient Satisfaction

Trial Safety

Trial Design

2 Treatment Groups

Autograft group
1 of 2
Allograft group (ClearFit)
1 of 2
Active Control

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. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Autograft group
Other
The autologous group will receive bone harvested from the patient's own body
Allograft group (ClearFit)
Device
The allograft group will receive a synthetic bone known as ClearFit

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post-operation
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year post-operation for reporting.

Closest Location

Sinai Hospital of Baltimore - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
All adult patients being considered for CP surgery by the investigating physician at the Life Bridge Health-Sinai Hospital of Baltimore
Able to read and speak English, or have LAR who reads and speaks English
Patients who need cranial reconstruction

Patient Q&A Section

What are the signs of surgical procedure, unspecified?

"Surgical procedure, unspecified, was more common among elderly and non-Hispanic whites than among black and Hispanic whites. Overall, however, the prevalence of the condition was very low, with overall incidences of 0.2%." - Anonymous Online Contributor

Unverified Answer

What is surgical procedure, unspecified?

"Surgery, surgical technique, or surgical procedure, surgical procedure, is not a common reason for an ICU stay, but it is associated with a high mortality. The most common reason is a pulmonary complication, but almost as common are sepsis, septicaemia, or shock." - Anonymous Online Contributor

Unverified Answer

What are common treatments for surgical procedure, unspecified?

"A meta-analysis that pooled results from several RCTs found no differences between acupuncture and other treatment, massage and other treatment, acupuncture and medication, and acupuncture and other treatment in pain scores. However, the number of trials was small, making a definite conclusion difficult. Another meta-analysis concluded that some treatment can be used with the support of scientific evidence because 'all treatments improve the pain in the short-term more than placebo' and 'all treatments improve the pain scores during the short- and medium-term compared to baseline'." - Anonymous Online Contributor

Unverified Answer

How many people get surgical procedure, unspecified a year in the United States?

"In the United States about 15.9 million people had surgery, including the one-time process of surgery, for surgical procedure, unspecified, in an average year. The annual prevalence of surgery, including the one-time process of surgery, for surgical procedure, unspecified. This should lead to a higher awareness among U.S residents and health care providers of this common medical condition." - Anonymous Online Contributor

Unverified Answer

Can surgical procedure, unspecified be cured?

"[Many patients of surgical procedure, unspecified do not have any of the complications or long-term side effects] Surgical procedure, unspecified does not worsen long-term survival or alter the risk of death more than for open heart bypass or coronary bypass procedure. However, the probability of death is higher for surgery, unspecified than for open heart surgery by the second year from surgery, unspecified[Power]and is similar to open heart surgery at 3 years [both conditions have a five-year survival (5-YSR) >90%(5-YSR) <95%(5-YSR)] The surgery, unspecified survival is about the same as surgery for lower extremity vascular disease." - Anonymous Online Contributor

Unverified Answer

What causes surgical procedure, unspecified?

"If these procedures are to be done on older or younger people, then procedures that are more likely to have a known or likely causative factor are also more likely to have a higher level of morbidity. Surgical procedures performed at lower levels of expertise have fewer of these known or likely causative factors, and can therefore likely to have a lower rate of morbidity. Most surgical procedures, as defined by this study, can cause minimal problems." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"Treatment may be used in combination with other treatments and is primarily determined by the site of disease involvement. In patients with recurrent disease, local treatment may be required in combination with systemic therapy." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with surgical procedure, unspecified?

"Findings from a recent study indicate that treatment should be considered for patients with surgical procedure, unspecified, who meet most of the definitions of the American College of Surgeons National Surgical Quality Improvement Program star rating system and are expected to have a high likelihood of surgery." - Anonymous Online Contributor

Unverified Answer

What is the latest research for surgical procedure, unspecified?

"Recent research has shown increased safety through use of minimally invasive techniques. This has allowed more options for new surgical techniques such as [corporophrenicosacral discectomy, anterior cervical discectomy, and fusion, laminectomy, interlaminar fusion, spondyloplasty, and total disc replacement. Current research in surgery continues, and new procedures may be added to this list. The latest techniques from various research labs and clinics are available on the [Power!-Find a Patient | Power!-Find a Patient @:www1.withpower.com]. Many of the newest procedures can start from [withPower!-Find a Patient @:www1.withpower.com]." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating surgical procedure, unspecified?

"There has been a growing trend in innovation in new and existing surgical procedures. The use of more extensive surgical procedures is becoming more common. Despite this, the numbers have not increased significantly." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"A variety of cancer specialists in cancer hospitals treat patients. There have been no studies of the quality of cancer care in any cancer institution yet. The most common specialty is surgeon (with 15,000), followed by oncologist (13,900), radiation oncologist (13,200), pathology (9,000), and obstetrician-gynecologist (8,900). The quality of surgical care in the United States has a very high correlation with cancer outcomes. It is important to compare cancer care in the cancer hospital to quality of medical care in the cancer hospital or clinic." - Anonymous Online Contributor

Unverified Answer

Has treatment proven to be more effective than a placebo?

"It is difficult to interpret the results of clinical trials because of problems with study design, lack of adequate placebo controls, and the problems with matching treatments. Nevertheless, the results of treatment trials have been reassuring as reported in the literature." - 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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