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A Clinical Registry of Orthobiologics Procedures

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ClinicalTrials.gov Identifier: NCT03011398
Recruitment Status : Enrolling by invitation
First Posted : January 5, 2017
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Regenexx, LLC

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.

Condition or disease Intervention/treatment
Orthopedic Disorder Procedure: Orthobiologic Procedures

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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures
Study Start Date : February 2016
Estimated Primary Completion Date : February 2036
Estimated Study Completion Date : February 2036

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


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients treated with orthobiologics procedures
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011398


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Sponsors and Collaborators
Regenexx, LLC
Investigators
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Principal Investigator: Christopher Centeno, MD Regenerative Sciences, LLC and Centeno-Schultz Clinic

Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Regenexx, LLC
ClinicalTrials.gov Identifier: NCT03011398     History of Changes
Other Study ID Numbers: RSI2015-REG01
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Musculoskeletal Diseases