A Clinical Registry of Orthobiologics Procedures

Study Overview
=================
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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.

Official Title
-----------------
Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures

Conditions
-----------------
Orthopedic Disorder

Intervention / Treatment
-----------------
* Procedure: Orthobiologic Procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Orthobiologic Procedures|To observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent Improvement | Mean improvement score, where -100=100% worse from baseline and 100=100% better or improved from baseline | 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scale | Mean numeric pain score, where 0=no pain and 10=worst possible pain. | 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment | 
| International Knee Documentation Committee form | Mean IKDC score, where 0=lowest level of knee function and 100=highest level of knee function. | 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment | 
| Lower Extremity Function Scale | Means LEFS score, where 0=very low function of the lower extremity and 80=very high function of the lower extremity | 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment | 
| Disabilities of the Arm, Shoulder and Hand form | Mean DASH score, where 0=no disability of the upper extremity and 100=most severe disability of the upper extremity. | 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment | 
| Oxford Hip Score | Mean OHS score, where 42-48=excellent, 34-41=good, 27-33=fair, 0-26=poor for hip pain and function. | 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment | 
| Functional Rating Index | Mean FRI score, where 0=no disability in function of the neck and back and 100=severe disability. | 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment | 
| Complications | Description of any medical complication related to receiving a treatment procedure | 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment | 
| Adverse Events | Description of adverse events occurring after treatment procedure | 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment | 
| Number of Re-injections to treated area | number of additional injections to treated area such as platelet rich plasma or stem cell treatment | 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment | 
| Number of Surgical Interventions to treated area | Number of surgical interventions to treated area after receiving treatment procedure | 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment |