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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03011398
Registration number
NCT03011398
Ethics application status
Date submitted
29/12/2016
Date registered
5/01/2017
Date last updated
28/09/2023
Titles & IDs
Public title
A Clinical Registry of Orthobiologics Procedures
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Scientific title
Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures
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Secondary ID [1]
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RSI2015-REG01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Orthopedic Disorder
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Surgery - Orthobiologic Procedures
Treatment: Surgery: Orthobiologic Procedures
To observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Percent Improvement
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Assessment method [1]
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Mean improvement score, where -100=100% worse from baseline and 100=100% better or improved from baseline
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Timepoint [1]
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1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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Secondary outcome [1]
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Pain Scale
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Assessment method [1]
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Mean numeric pain score, where 0=no pain and 10=worst possible pain.
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Timepoint [1]
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1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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Secondary outcome [2]
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International Knee Documentation Committee form
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Assessment method [2]
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Mean IKDC score, where 0=lowest level of knee function and 100=highest level of knee function.
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Timepoint [2]
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1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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Secondary outcome [3]
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Lower Extremity Function Scale
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Assessment method [3]
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Means LEFS score, where 0=very low function of the lower extremity and 80=very high function of the lower extremity
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Timepoint [3]
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1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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Secondary outcome [4]
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Disabilities of the Arm, Shoulder and Hand form
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Assessment method [4]
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Mean DASH score, where 0=no disability of the upper extremity and 100=most severe disability of the upper extremity.
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Timepoint [4]
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1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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Secondary outcome [5]
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Oxford Hip Score
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Assessment method [5]
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Mean OHS score, where 42-48=excellent, 34-41=good, 27-33=fair, 0-26=poor for hip pain and function.
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Timepoint [5]
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1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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Secondary outcome [6]
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Functional Rating Index
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Assessment method [6]
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Mean FRI score, where 0=no disability in function of the neck and back and 100=severe disability.
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Timepoint [6]
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1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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Secondary outcome [7]
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Complications
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Assessment method [7]
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Description of any medical complication related to receiving a treatment procedure
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Timepoint [7]
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1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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Secondary outcome [8]
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Adverse Events
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Assessment method [8]
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Description of adverse events occurring after treatment procedure
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Timepoint [8]
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1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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Secondary outcome [9]
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Number of Re-injections to treated area
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Assessment method [9]
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number of additional injections to treated area such as platelet rich plasma or stem cell treatment
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Timepoint [9]
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1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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Secondary outcome [10]
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Number of Surgical Interventions to treated area
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Assessment method [10]
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Number of surgical interventions to treated area after receiving treatment procedure
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Timepoint [10]
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1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- none
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/02/2036
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Actual
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Sample size
Target
50000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Nepean Specialist Sports Medicine - Kingswood
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Recruitment postcode(s) [1]
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2747 - Kingswood
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Florida
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Illinois
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Iowa
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Kentucky
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Louisiana
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Maryland
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Minnesota
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New Jersey
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New York
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Texas
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Utah
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Vermont
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Virginia
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Country [21]
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India
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State/province [21]
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Telangana
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Regenexx, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03011398
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Trial related presentations / publications
Centeno CJ, Schultz JR, Cheever M, Robinson B, Freeman M, Marasco W. Safety and complications reporting on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2010 Mar;5(1):81-93. doi: 10.2174/157488810790442796.
Centeno CJ, Schultz JR, Cheever M, Freeman M, Faulkner S, Robinson B, Hanson R. Safety and complications reporting update on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2011 Dec;6(4):368-78. doi: 10.2174/157488811797904371.
Bain BJ. Morbidity associated with bone marrow aspiration and trephine biopsy - a review of UK data for 2004. Haematologica. 2006 Sep;91(9):1293-4.
Nejadnik H, Hui JH, Feng Choong EP, Tai BC, Lee EH. Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Am J Sports Med. 2010 Jun;38(6):1110-6. doi: 10.1177/0363546509359067. Epub 2010 Apr 14.
Wakitani S, Okabe T, Horibe S, Mitsuoka T, Saito M, Koyama T, Nawata M, Tensho K, Kato H, Uematsu K, Kuroda R, Kurosaka M, Yoshiya S, Hattori K, Ohgushi H. Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med. 2011 Feb;5(2):146-50. doi: 10.1002/term.299.
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Public notes
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Contacts
Principal investigator
Name
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Christopher Centeno, MD
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Address
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Regenerative Sciences, LLC and Centeno-Schultz Clinic
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03011398
Download to PDF