Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT03011398

A Clinical Registry of Orthobiologics Procedures

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Orthopedic Disorder Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Nepean Specialist Sports Medicine, Kingswood, New South Wales, Australia

Loading trial locations.

About this study

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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthobiologic Procedures

Procedure

To observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders.

Primary outcomes

  1. Change in Percent Improvement

    Time frame: 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 outcomes

  1. Pain Scale

    Time frame: 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.

  2. International Knee Documentation Committee form

    Time frame: 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.

  3. Lower Extremity Function Scale

    Time frame: 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

  4. Disabilities of the Arm, Shoulder and Hand form

    Time frame: 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.

  5. Oxford Hip Score

    Time frame: 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.

  6. Functional Rating Index

    Time frame: 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.

  7. Complications

    Time frame: 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

  8. Adverse Events

    Time frame: 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

  9. Number of Re-injections to treated area

    Time frame: 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

  10. Number of Surgical Interventions to treated area

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Regenexx, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2036
Study completion
2036
First posted
Jan 5, 2017
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.