A Clinical Registry of Orthobiologics Procedures

April 2, 2025 updated by: Regenexx, LLC

Interventional Orthopedics Foundation Patient Registry Database-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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Nepean Specialist Sports Medicine
  • India
    • Telangana
      • Hyderabad, Telangana, India, 500001
        • RegenOrthoSport
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Catalyst Pain Solutions
    • California
      • Beverly Hills, California, United States, 90035
        • Healthlink Center
      • Oceanside, California, United States, 92056
        • Healthlink Center
      • San Rafael, California, United States, 94903
        • Healthlink Center
      • Thousand Oaks, California, United States, 91361
        • Southern California Orthopedic Institute
      • Van Nuys, California, United States, 91405
        • Southern California Orthopedic Institute-Van Nuys
    • Colorado
      • Broomfield, Colorado, United States, 80021
        • Centeno-Schultz Clinic
      • Broomfield, Colorado, United States, 80026
        • Regenexx
    • Florida
      • Sarasota, Florida, United States, 34243
        • New reGeneration Orthopedics
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Chicago Arthritis
      • Des Plaines, Illinois, United States, 60016
        • Orthopedic Stem Cell Resource
    • Iowa
      • Des Moines, Iowa, United States, 50321
        • Harbor View Medical
    • Kentucky
      • Louisville, Kentucky, United States, 40223
        • Bodyworks Musculoskeletal Medicine
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Total Care-LA
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Stem Cell ARTS-MD
    • Minnesota
      • Waite Park, Minnesota, United States, 56387
        • RejuvMedical
    • New Jersey
      • Cedar Knolls, New Jersey, United States, 07927
        • New Jersey Sports Medicine
      • Oakhurst, New Jersey, United States, 07755
        • Orthopedic Stem Cell Solutions
      • Wayne, New Jersey, United States, 07470
        • Rehabilitation Center of New Jersey
    • New York
      • New York, New York, United States, 10001
        • Rehabilitation Center of New York
    • Ohio
      • Cincinnati, Ohio, United States, 45241
        • Beacon Orthopaedics
      • Toledo, Ohio, United States, 43612
        • Promedica
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • RegenOrthoSport
    • Oregon
      • Hood River, Oregon, United States, 97031
        • Columbia Pain Management
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15238
        • Rehabilitation and Pain Specialists
      • Springfield, Pennsylvania, United States, 19064
        • Center for Sports Medicine
    • Texas
      • Dallas, Texas, United States, 75230
        • RegenOrthoSport
    • Utah
      • South Jordan, Utah, United States, 84095
        • Wasatch Pain Solutions
    • Vermont
      • Winooski, Vermont, United States, 05404
        • Vermont Regenerative Medicine
    • Virginia
      • McLean, Virginia, United States, 22102
        • Stem Cell ARTS-VA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients treated with orthobiologics procedures

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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.
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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
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
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.
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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.
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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.
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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
1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regenexx, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Centeno, MD, Regenerative Sciences, LLC and Centeno-Schultz Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2036

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RSI2015-REG01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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