A Clinical Registry of Orthobiologics Procedures

Regenexx

Status: Invitation-only

Conditions: Orthopedic Disorder

Treatments: Procedure: Orthobiologic Procedures

Study type: Observational

Funder types: Industry

Identifiers

NCT03011398

RSI2015-REG01

Details and patient eligibility

About

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.

Full 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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.

Enrollment: 50,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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