Orthopedic Disorder
Conditions
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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.
Interventions
PROCEDUREOrthobiologic Procedures
To observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders.
Sponsors
Regenexx, LLC
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
Countries
Australia, India, United States
Outcome results
None listed