NCT03011398

A Clinical Registry of Orthobiologics Procedures

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 50,000 (estimated)
• Sponsor: Regenexx, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.

Conditions

• Orthopedic Disorder

Interventions

Type	Name	Description
PROCEDURE	Orthobiologic Procedures	To observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders.

Timeline

• Start date: 2016-02-01
• Primary completion: 2036-02-01
• Completion: 2036-02-01
• First posted: 2017-01-05
• Last updated: 2025-04-06

Locations

32 sites across 3 countries: United States, Australia, India