Orthopedic DisorderNCT03011398
A Clinical Registry of Orthobiologics Procedures
An observational study of Orthopedic Disorder, run by Regenexx, LLC at 32 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Orthobiologic Procedures
- Type of treatment
- Surgery or procedure
- How many people
- 50,000 participants
- Where
- 32 sitesin 3 countries
- Study dates
- Feb 2016to Feb 2036
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients treated with orthobiologics procedures
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
32 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 3 countries
United States30 sites
Healthlink Center
Beverly Hills, California, 90035
Centeno-Schultz Clinic
Broomfield, Colorado, 80021
Regenexx
Broomfield, Colorado, 80026
New Jersey Sports Medicine
Cedar Knolls, New Jersey, 07927
Stem Cell ARTS-MD
Chevy Chase, Maryland, 20815
Chicago Arthritis
Chicago, Illinois, 60657
Beacon Orthopaedics
Cincinnati, Ohio, 45241
RegenOrthoSport
Dallas, Texas, 75230
Harbor View Medical
Des Moines, Iowa, 50321
Orthopedic Stem Cell Resource
Des Plaines, Illinois, 60016
Columbia Pain Management
Hood River, Oregon, 97031
Total Care-LA
Lafayette, Louisiana, 70503
Bodyworks Musculoskeletal Medicine
Louisville, Kentucky, 40223
Stem Cell ARTS-VA
McLean, Virginia, 22102
Rehabilitation Center of New York
New York, New York, 10001
Orthopedic Stem Cell Solutions
Oakhurst, New Jersey, 07755
Healthlink Center
Oceanside, California, 92056
Catalyst Pain Solutions
Phoenix, Arizona, 85008
Rehabilitation and Pain Specialists
Pittsburgh, Pennsylvania, 15238
Healthlink Center
San Rafael, California, 94903
New reGeneration Orthopedics
Sarasota, Florida, 34243
Wasatch Pain Solutions
South Jordan, Utah, 84095
Center for Sports Medicine
Springfield, Pennsylvania, 19064
Southern California Orthopedic Institute
Thousand Oaks, California, 91361
ProMedica
Toledo, Ohio, 43612
RegenOrthoSport
Tulsa, Oklahoma, 74136
Southern California Orthopedic Institute-Van Nuys
Van Nuys, California, 91405
RejuvMedical
Waite Park, Minnesota, 56387
Rehabilitation Center of New Jersey
Wayne, New Jersey, 07470
Vermont Regenerative Medicine
Winooski, Vermont, 05404
Australia1 site
Nepean Specialist Sports Medicine
Kingswood, New South Wales, 2747
About this study
Official title: 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.
Read the 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
- Being tested
- Orthobiologic Procedures
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthobiologic ProceduresProcedure or surgery
To observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Improvement
Mean improvement score, where -100=100% worse from baseline and 100=100% better or improved from baseline
Measured: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcomes (10)
Pain Scale
Mean numeric pain score, where 0=no pain and 10=worst possible pain.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
International Knee Documentation Committee form
Mean IKDC score, where 0=lowest level of knee function and 100=highest level of knee function.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Lower Extremity Function Scale
Means LEFS score, where 0=very low function of the lower extremity and 80=very high function of the lower extremity
Measured: 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
Mean DASH score, where 0=no disability of the upper extremity and 100=most severe disability of the upper extremity.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Oxford Hip Score
Mean OHS score, where 42-48=excellent, 34-41=good, 27-33=fair, 0-26=poor for hip pain and function.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Functional Rating Index
Mean FRI score, where 0=no disability in function of the neck and back and 100=severe disability.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Complications
Description of any medical complication related to receiving a treatment procedure
Measured: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Adverse Events
Description of adverse events occurring after treatment procedure
Measured: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Number of Re-injections to treated area
number of additional injections to treated area such as platelet rich plasma or stem cell treatment
Measured: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Number of Surgical Interventions to treated area
Number of surgical interventions to treated area after receiving treatment procedure
Measured: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionFeb 2036 (estimated)
- Study completionFeb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Regenexx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Centeno, MD, Principal investigator, Regenerative Sciences, LLC and Centeno-Schultz Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011398
- Sponsor's protocol ID
- RSI2015-REG01
- Status last verified
- Apr 2025
- First submitted
- 29 Dec 2016
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 19951252Centeno 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.
PubMed 22023622Bain BJ. Morbidity associated with bone marrow aspiration and trephine biopsy - a review of UK data for 2004. Haematologica. 2006 Sep;91(9):1293-4.
PubMed 16956842Nejadnik 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.
PubMed 20392971Wakitani 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.
PubMed 20603892Centeno CJ, Berger DR, Money BT, Dodson E, Urbanek CW, Steinmetz NJ. Percutaneous autologous bone marrow concentrate for knee osteoarthritis: patient-reported outcomes and progenitor cell content. Int Orthop. 2022 Oct;46(10):2219-2228. doi: 10.1007/s00264-022-05524-9. Epub 2022 Aug 6.
PubMed 35932306Centeno CJ, Money BT, Dodson E, Stemper I, Steinmetz NJ. The rate of venous thromboembolism after knee bone marrow concentrate procedures: should we anticoagulate? Int Orthop. 2022 Oct;46(10):2213-2218. doi: 10.1007/s00264-022-05500-3. Epub 2022 Jul 18.
PubMed 35844014Centeno C, Markle J, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. J Transl Med. 2018 Sep 3;16(1):246. doi: 10.1186/s12967-018-1623-3.
PubMed 30176875Centeno C, Markle J, Dodson E, Stemper I, Williams CJ, Hyzy M, Ichim T, Freeman M. Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy. J Transl Med. 2017 Sep 22;15(1):197. doi: 10.1186/s12967-017-1300-y.
PubMed 28938891
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures
- ClinicalTrials.gov ID
- NCT03011398
- Acronym / sponsor ID
- RSI2015-REG01
- Conditions
- Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Regenexx, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2036 (estimated)
- Study completion
- Feb 2036 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated with orthobiologics procedures
Key inclusion criteria (4 listed)
- Candidates must meet ALL of the following:
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthobiologic ProceduresTo observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders. | Procedure or surgery | – |
Primary outcome
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
10 secondary outcomes
Pain Scale
Time frame: 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
Lower Extremity Function Scale
Time frame: 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
Oxford Hip Score
Time frame: 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
Complications
Time frame: 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
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 Surgical Interventions to treated area
Time frame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Background: PubMed 19951252Centeno 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.
- Background: PubMed 22023622Centeno 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.
- Background: PubMed 16956842Bain BJ. Morbidity associated with bone marrow aspiration and trephine biopsy - a review of UK data for 2004. Haematologica. 2006 Sep;91(9):1293-4.
- Background: PubMed 20392971Nejadnik 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.
- Background: PubMed 20603892Wakitani 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.
- Derived from this study: PubMed 35932306Centeno CJ, Berger DR, Money BT, Dodson E, Urbanek CW, Steinmetz NJ. Percutaneous autologous bone marrow concentrate for knee osteoarthritis: patient-reported outcomes and progenitor cell content. Int Orthop. 2022 Oct;46(10):2219-2228. doi: 10.1007/s00264-022-05524-9. Epub 2022 Aug 6.
- Derived from this study: PubMed 35844014Centeno CJ, Money BT, Dodson E, Stemper I, Steinmetz NJ. The rate of venous thromboembolism after knee bone marrow concentrate procedures: should we anticoagulate? Int Orthop. 2022 Oct;46(10):2213-2218. doi: 10.1007/s00264-022-05500-3. Epub 2022 Jul 18.
- Derived from this study: PubMed 30176875Centeno C, Markle J, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. J Transl Med. 2018 Sep 3;16(1):246. doi: 10.1186/s12967-018-1623-3.
- Derived from this study: PubMed 28938891Centeno C, Markle J, Dodson E, Stemper I, Williams CJ, Hyzy M, Ichim T, Freeman M. Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy. J Transl Med. 2017 Sep 22;15(1):197. doi: 10.1186/s12967-017-1300-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Centeno, MD principal investigator
Regenerative Sciences, LLC and Centeno-Schultz Clinic
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Regenexx, LLC at 32 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Australia, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent Improvement (time frame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03011398, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.