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By invitation only NCT03011398

A Clinical Registry of Orthobiologics Procedures

Conditions: Orthopedic Disorder

Sponsor: Regenexx, LLC

trial.available_in: БГ
Overview
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.
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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.
Who can participate
Inclusion Criteria: * Candidates must meet ALL of the following: 1. Voluntary signature of the IRB approved Informed Consents, 2. Treated with a Regenexx procedure 3. 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 Exclusion Criteria: * none
Locations 3
Australia (1)
Nepean Specialist Sports Medicine
Kingswood , New South Wales
India (1)
RegenOrthoSport
Hyderabad , Telangana
United States (1)
Catalyst Pain Solutions
Phoenix , Arizona
Technical details
Status
By invitation only
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
01.02.2016
Completion date
01.02.2036
Registry ID
NCT03011398
Source
anzctr
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