Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. for Arthrosis

Phase-Based Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Florida, Jacksonville, FL
Arthrosis+1 More
Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. - Biological
Eligibility
18+
All Sexes
Eligible conditions
Arthrosis

Study Summary

This study is evaluating whether a specific type of blood cell treatment is safe for people.

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Eligible Conditions

  • Arthrosis
  • Osteoarthritis
  • Osteoarthritis of the Shoulder

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure. will improve 2 primary outcomes and 5 secondary outcomes in patients with Arthrosis. Measurement will happen over the course of 1-3 Weeks Post-Procedure.

1-3 Weeks Post-Procedure
Adverse Reactions
Morbidity related to bone marrow aspirations from iliac crests
12 Months
To collect and explore pre and post injection measures of cartilage status in the affected shoulder.
Month 12
Change in Subjective Shoulder Value
Change in Visual Analog Scale (VAS)
Change in range of motion
Month 12
Change in American Shoulder and Elbow Surgeons Shoulder Score (ASES)

Trial Safety

Trial Design

2 Treatment Groups

Control
Subjects with Osteoarthritis of the shoulders

This trial requires 12 total participants across 2 different treatment groups

This trial involves 2 different treatments. Concentrated Bone Marrow Aspirate Administration After Comprehensive Arthroscopic Management (CAM) Surgical Procedure. is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Subjects with Osteoarthritis of the shoulders
Biological
Subjects diagnosed with Osteoarthritis of the shoulders will be injected with concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly screening, pre-operatively, pre-injection and at 1 week, 6 weeks, 3 months, 6 months and 12 months following surgery for reporting.

Closest Location

Mayo Clinic in Florida - Jacksonville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients can sign a form agreeing to take part in a study after they are informed of the risks and benefits associated with that study. show original
Subjects must have OA in a single or bilateral shoulder(s) with an inferior osteophyte measuring less than 7 mm. show original
> We found that the mean joint space width in the study shoulder was 1 mm. show original
A score of 14.1 to 88.5 on the ASES indicates that you are a very strong supporter of the president. show original
You must have osteoarthritis and have tried one of the following conservative treatments for at least 6 months: activity modification, physical therapy, or anti-inflammatory or injection therapy. show original
Subjects are divided into male and female groups. show original
People must be 50 years of age or older to be eligible for this study. show original

Patient Q&A Section

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

Can arthrosis be cured?

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Findings from a recent study have serious implications for patients: If there is no treatment for symptomatic degenerative joint disease, then the patient will most likely have to live with arthritis for the rest of their life.

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What are common treatments for arthrosis?

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Arthrosis patients usually choose topical treatments over oral medications when treatment is available. The most common topical treatments are corticosteroid and non-steroidal anti-inflammatory drugs. Common treatments for other types of arthritis include non-steroidal anti-inflammatory drugs, corticosteroids, acetaminophen and topical non-steroidal anti-inflammatory drugs.\n

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What are the signs of arthrosis?

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Arthrosis can be classified into three stages. These stages, according to the American College of Radiology, include mild, moderate and severe arthritis. Mild arthrosis can have a slow progression of pain, stiffness, deformity and function alteration, but the impact on daily living is weak. Moderate arthrosis can have more symptoms such as stiffness and deformity, but the function could still be normal. Severe arthrosis will have a rapid progression of symptoms, especially pain and stiffness. There will be joint instability and the possibility of falling over. The diagnosis is made most commonly by using clinical examination. Imaging or a radiograph must be done to evaluate the degree of disease or arthritis.

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What causes arthrosis?

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Arthrosis may represent either a true degenerative change or may be a primary predisposing factor which then leads to loss of function of the joint. Diagnosis of arthrosis is based on symptoms and is often made to prevent amputation.

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What is arthrosis?

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Arthropathic is a disorder causing severe disabling pain in the joints of the skeleton. The joint affected is the most likely to be the knee or hip. Arthritis can be classified into [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis) and rheumatoid arthritis. Most cases of osteoarthritis are due to old age but can be present from birth and, to an increasing degree, from childhood. Rheumatoid arthritis is an autoimmune disease. Typically, it follows infection by the Epstein-Barr virus (a human cancer virus), or by other viruses such as the measles.

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How many people get arthrosis a year in the United States?

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There are many persons who develop radiographic arthritis for the first time during their early years. The risk of radiographic arthritis is significantly and independently associated with a number of factors including age, duration of disease before diagnosis and number of doctors with patient contacts.

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What is concentrated bone marrow aspirate administration after comprehensive arthroscopic management (cam) surgical procedure.?

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Cam surgical procedure seems to be a better treatment option for subacromial impingement (SI) than arthroscopic arthrosecomy (AR) in elderly patients>75 years old.[Power(http://www.withpower.com/clinical-trials/arthroscopy)] As a standard treatment for SI, we recommend CAM procedure, including a high-quality, well-expanded joint capsule, combined with CBMA. With respect to AR, we need to consider the benefits of the surgical technique compared with the benefits of arthroscopic procedure in terms of postoperative pain control and restoring functional outcomes.

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Does arthrosis run in families?

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Inheriting arthrosis, a disorder of the skeletal system, is a rare condition in the U.S. population with an overall prevalence of around 0.04%. Families with arthrosis in the first-degree relative are more likely to transmit the disease. A recessive mode of inheritance is proposed.

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What are the common side effects of concentrated bone marrow aspirate administration after comprehensive arthroscopic management (cam) surgical procedure.?

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The incidence of new side effects of CBA after cam arthroplasty appears to be very low. None of the common SAEs encountered in CBA and those in non-CBA patients in our observational study showed a statistically significant incidence difference between both groups.

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What is the average age someone gets arthrosis?

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Arthrosis is a common disease that is seen as early as age 21. Once it develops, it is much more common to see them during middle age.

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Does concentrated bone marrow aspirate administration after comprehensive arthroscopic management (cam) surgical procedure. improve quality of life for those with arthrosis?

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Compared to CAM arthroscopy, the arthroscopic-mediated injection of BM-MMCs improved most clinical variables with an exception of overall patient satisfaction. Nevertheless, patients preferred to receive the combined procedure because it facilitated a quicker post-operative recovery.

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Who should consider clinical trials for arthrosis?

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Clinical researchers need to consider two criteria when assessing whether or not patients will benefit from a clinical trial: 1. The severity of the current symptoms or how a patient has been treated in the past; and 2. The likelihood that the treatment could cure the patient's symptoms. Recent findings [Treatment outcome in inflammatory arthrosis of the hip (TIHR)] found that patients with arthrosis were less likely to demonstrate the improvement that clinical trials can provide. However, many patients were satisfied with the medications and surgery options that were offered to them, but only if those treatments met their needs. Therefore, patients may be willing to take part in clinical trials with uncertain benefits.

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