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Enrolling by invitation NCT03011398

A Clinical Registry of Orthobiologics Procedures

— Observational Orthopedic Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Orthobiologic Procedures.
Who it may be relevant to
Registry conditions: Orthopedic Disorder. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Interventional Orthopedics Foundation Patient Registry Database-A Clinical Registry of Orthobiologics Procedures

Overview

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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.

Interventions

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

Primary outcome measures

  • Change in Percent Improvement [Time frame: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • none

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 30 centers
  • Catalyst Pain Solutions — Phoenix
  • Healthlink Center — Beverly Hills
  • Healthlink Center — Oceanside
  • Healthlink Center — San Rafael
  • Southern California Orthopedic Institute — Thousand Oaks
  • Southern California Orthopedic Institute-Van Nuys — Van Nuys
  • Centeno-Schultz Clinic — Broomfield
  • Regenexx — Broomfield
  • … and 22 more centers
Australia · 1 center
  • Nepean Specialist Sports Medicine — Kingswood
India · 1 center
  • RegenOrthoSport — Hyderabad

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. PMID 19951252
  • 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. PMID 22023622
  • 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. PMID 16956842
  • 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. PMID 20392971
  • 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. PMID 20603892
  • 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. PMID 35932306
  • 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. PMID 35844014
  • 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. PMID 30176875

Identifiers

NCT: NCT03011398 · RSI2015-REG01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗