A Clinical Registry of Orthobiologics Procedures
- Conditions
- Orthopedic Disorder
- Registration Number
- NCT03011398
- Lead Sponsor
- Regenexx, LLC
- Brief Summary
The purpose of the Registry study is to observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures for treatment of musculoskeletal disorders.
- Detailed Description
This Registry was designed to assure that the benefits and knowledge gained by studying clinical outcomes associated with the use of percutaneous orthopedic procedures outweigh the potential risks to the patients. The primary objective of this Registry is to observe the improvements in subject-reported clinical outcomes for these procedures used to treat musculoskeletal disorders. Secondary objectives include evaluating post-treatment complication, adverse events, re-injections, and surgical intervention. Patients receiving percutaneous orthopedic treatments are asked to enroll before receiving treatment and complete a set of baseline questionnaires regarding pain and functionality of the area of the body being treated (i.e. knee, shoulder, spine, etc). Follow-up outcomes are collected at 1 month, 3 months, 6 months, 12 months, 18 months, and annually 2-20 years post-injection. Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50000
-
Candidates must meet ALL of the following:
- Voluntary signature of the IRB approved Informed Consents,
- Treated with a Regenexx procedure
- Have a musculoskeletal condition appropriate for the procedure such as osteoarthritis or internal joint derangement; ligament or tendon injury; intervertebral disc degeneration; protrusion, extrusion, or annular tear; muscle tear
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Percent Improvement 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment Mean improvement score, where -100=100% worse from baseline and 100=100% better or improved from baseline
- Secondary Outcome Measures
Name Time Method Oxford Hip Score 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment Mean OHS score, where 42-48=excellent, 34-41=good, 27-33=fair, 0-26=poor for hip pain and function.
Complications 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment Description of any medical complication related to receiving a treatment procedure
Number of Re-injections to treated area 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment number of additional injections to treated area such as platelet rich plasma or stem cell treatment
Number of Surgical Interventions to treated area 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment Number of surgical interventions to treated area after receiving treatment procedure
International Knee Documentation Committee form 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment Mean IKDC score, where 0=lowest level of knee function and 100=highest level of knee function.
Disabilities of the Arm, Shoulder and Hand form 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment Mean DASH score, where 0=no disability of the upper extremity and 100=most severe disability of the upper extremity.
Pain Scale 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment Mean numeric pain score, where 0=no pain and 10=worst possible pain.
Functional Rating Index 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment Mean FRI score, where 0=no disability in function of the neck and back and 100=severe disability.
Adverse Events 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment Description of adverse events occurring after treatment procedure
Lower Extremity Function Scale 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment Means LEFS score, where 0=very low function of the lower extremity and 80=very high function of the lower extremity
Trial Locations
- Locations (28)
Columbia Pain Management
🇺🇸Hood River, Oregon, United States
Vermont Regenerative Medicine
🇺🇸Winooski, Vermont, United States
RejuvMedical
🇺🇸Waite Park, Minnesota, United States
Total Care-LA
🇺🇸Lafayette, Louisiana, United States
Bodyworks Musculoskeletal Medicine
🇺🇸Louisville, Kentucky, United States
Wasatch Pain Solutions
🇺🇸South Jordan, Utah, United States
Orthopedic Stem Cell Resource
🇺🇸Des Plaines, Illinois, United States
Orthopedic Stem Cell Solutions
🇺🇸Oakhurst, New Jersey, United States
ProMedica
🇺🇸Toledo, Ohio, United States
RegenOrthoSport
🇮🇳Hyderabad, Telangana, India
Rehabilitation Center of New Jersey
🇺🇸Wayne, New Jersey, United States
Center for Sports Medicine
🇺🇸Springfield, Pennsylvania, United States
New Jersey Sports Medicine
🇺🇸Cedar Knolls, New Jersey, United States
Nepean Specialist Sports Medicine
🇦🇺Kingswood, New South Wales, Australia
Rehabilitation Center of New York
🇺🇸New York, New York, United States
Southern California Orthopedic Institute-Van Nuys
🇺🇸Van Nuys, California, United States
Southern California Orthopedic Institute
🇺🇸Thousand Oaks, California, United States
Centeno-Schultz Clinic
🇺🇸Broomfield, Colorado, United States
Regenexx
🇺🇸Broomfield, Colorado, United States
Harbor View Medical
🇺🇸Des Moines, Iowa, United States
Stem Cell ARTS-MD
🇺🇸Chevy Chase, Maryland, United States
Stem Cell ARTS-VA
🇺🇸McLean, Virginia, United States
Catalyst Pain Solutions
🇺🇸Phoenix, Arizona, United States
Healthlink Center
🇺🇸San Rafael, California, United States
New reGeneration Orthopedics
🇺🇸Sarasota, Florida, United States
Chicago Arthritis
🇺🇸Chicago, Illinois, United States
Beacon Orthopaedics
🇺🇸Cincinnati, Ohio, United States
Rehabilitation and Pain Specialists
🇺🇸Pittsburgh, Pennsylvania, United States