CAM Procedure + BMAC for Shoulder Osteoarthritis
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking anti-inflammatory medications and anti-rheumatic disease medications before joining the trial. Specifically, you must not take anti-inflammatory medications for 14 days before the baseline visit and anti-rheumatic medications for 3 months prior to study entry.
What data supports the effectiveness of the treatment CAM Procedure + BMAC for Shoulder Osteoarthritis?
Research shows that bone marrow aspirate concentrate (BMAC) has been used to treat osteoarthritis in other joints, like the hip and knee, with some success in improving symptoms and slowing cartilage damage. However, results can vary due to different preparation methods, and more research is needed to confirm its effectiveness specifically for shoulder osteoarthritis.12345
Is the CAM Procedure + BMAC treatment generally safe for humans?
The safety of Bone Marrow Aspirate Concentrate (BMAC) has been studied in various conditions, but more research is needed to fully understand its safety and effectiveness. While it is used in orthopedic treatments, the results and safety can vary depending on the preparation methods and specific conditions being treated.13467
How is the CAM Procedure + BMAC treatment different from other treatments for shoulder osteoarthritis?
What is the purpose of this trial?
Researchers want to find out more about the side effects of Bone Marrow Aspirate Concentrate (BMAC) and what doses of BMAC are safe for people.
Research Team
Bradley Schoch, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for men and women over 50 with primary shoulder osteoarthritis who've tried treatments like physical therapy or anti-inflammatory drugs for at least 6 months. They must have a specific level of joint space in the affected shoulder and an ASES score within a certain range. Excluded are those with other significant health issues, recent use of certain medications, or previous major shoulder surgeries.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Assessment
Participants undergo pre-operative assessments including pain and shoulder function evaluations
Treatment
Participants receive arthroscopic surgery followed by injection of Bone Marrow Aspirate Concentrate (BMAC)
Post-operative Monitoring
Participants are monitored for adverse reactions and morbidity related to the procedure
Follow-up
Participants are monitored for safety and effectiveness, including pain and shoulder function assessments
Treatment Details
Interventions
- Comprehensive Arthroscopic Management (CAM) surgical procedure
- Concentrated bone marrow aspirate
Comprehensive Arthroscopic Management (CAM) surgical procedure is already approved in United States, European Union for the following indications:
- Severe shoulder osteoarthritis
- Glenohumeral osteoarthritis
- Severe shoulder osteoarthritis
- Glenohumeral osteoarthritis
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Who Is Running the Clinical Trial?
Shane A. Shapiro
Lead Sponsor