Clinical trial NCT03011398: A Clinical Registry of Orthobiologics Procedures
Official title: Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Orthopedic Disorder
Lead sponsor: Regenexx, LLC
Sponsor class: INDUSTRY
First posted: 2017-01-05
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with orthobiologics procedures

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.

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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.

Eligibility 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

Primary outcomes:
measure: Change in Percent Improvement
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Secondary outcomes:
measure: Pain Scale
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
measure: International Knee Documentation Committee form
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
measure: Lower Extremity Function Scale
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
measure: Disabilities of the Arm, Shoulder and Hand form
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
measure: Oxford Hip Score
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
measure: Functional Rating Index
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
measure: Complications
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
measure: Adverse Events
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
measure: Number of Re-injections to treated area
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
measure: Number of Surgical Interventions to treated area
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Catalyst Pain Solutions
state: Arizona
city: Beverly Hills
country: United States
facility: Healthlink Center
state: California
city: Oceanside
country: United States
facility: Healthlink Center
state: California
city: San Rafael
country: United States
facility: Healthlink Center
state: California
city: Thousand Oaks
country: United States
facility: Southern California Orthopedic Institute
state: California
city: Van Nuys
country: United States
facility: Southern California Orthopedic Institute-Van Nuys
state: California
city: Broomfield
country: United States
facility: Centeno-Schultz Clinic
state: Colorado
city: Broomfield
country: United States
facility: Regenexx
state: Colorado
city: Sarasota
country: United States
facility: New reGeneration Orthopedics
state: Florida
city: Chicago
country: United States
facility: Chicago Arthritis
state: Illinois
city: Des Plaines
country: United States
facility: Orthopedic Stem Cell Resource
state: Illinois
city: Des Moines
country: United States
facility: Harbor View Medical
state: Iowa
city: Louisville
country: United States
facility: Bodyworks Musculoskeletal Medicine
state: Kentucky
city: Lafayette
country: United States
facility: Total Care-LA
state: Louisiana
city: Chevy Chase
country: United States
facility: Stem Cell ARTS-MD
state: Maryland
city: Waite Park
country: United States
facility: RejuvMedical
state: Minnesota
city: Cedar Knolls
country: United States
facility: New Jersey Sports Medicine
state: New Jersey
city: Oakhurst
country: United States
facility: Orthopedic Stem Cell Solutions
state: New Jersey
city: Wayne
country: United States
facility: Rehabilitation Center of New Jersey
state: New Jersey
city: New York
country: United States
facility: Rehabilitation Center of New York
state: New York
city: Cincinnati
country: United States
facility: Beacon Orthopaedics
state: Ohio
city: Toledo
country: United States
facility: ProMedica
state: Ohio
city: Tulsa
country: United States
facility: RegenOrthoSport
state: Oklahoma
city: Hood River
country: United States
facility: Columbia Pain Management
state: Oregon
city: Pittsburgh
country: United States
facility: Rehabilitation and Pain Specialists
state: Pennsylvania
city: Springfield
country: United States
facility: Center for Sports Medicine
state: Pennsylvania
city: Dallas
country: United States
facility: RegenOrthoSport
state: Texas
city: South Jordan
country: United States
facility: Wasatch Pain Solutions
state: Utah
city: Winooski
country: United States
facility: Vermont Regenerative Medicine
state: Vermont
city: McLean
country: United States
facility: Stem Cell ARTS-VA
state: Virginia
city: Kingswood
country: Australia
facility: Nepean Specialist Sports Medicine
state: New South Wales
city: Hyderabad
country: India
facility: RegenOrthoSport
state: Telangana
Study officials:
affiliation: Regenerative Sciences, LLC and Centeno-Schultz Clinic
name: Christopher Centeno, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Centeno 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.
citation: Centeno 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.
citation: Centeno 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.
citation: Centeno 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.