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Набор по приглашению NCT03011398

A Clinical Registry of Orthobiologics Procedures

— Наблюдательное Orthopedic Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Orthobiologic Procedures.
Кому может быть актуально
Состояния в реестре: Orthopedic Disorder. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Австралия, Индия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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 Subjects are withdrawn from the Registry prematurely if a surgical operation occurs.

Вмешательства

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

Первичные конечные точки

  • Change in Percent Improvement [Срок оценки: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]
Вторичные конечные точки (10)
  • Pain Scale [Срок оценки: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]
  • International Knee Documentation Committee form [Срок оценки: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]
  • Lower Extremity Function Scale [Срок оценки: 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 [Срок оценки: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]
  • Oxford Hip Score [Срок оценки: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]
  • Functional Rating Index [Срок оценки: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]
  • Complications [Срок оценки: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]
  • Adverse Events [Срок оценки: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]
  • Number of Re-injections to treated area [Срок оценки: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]
  • Number of Surgical Interventions to treated area [Срок оценки: 1 month, 3 months, 6 months, 12 months, 18 months and annually 2-20 years post treatment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • none

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 30 центров
  • 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
  • … и ещё 22 центра
Австралия · 1 центр
  • Nepean Specialist Sports Medicine — Kingswood
Индия · 1 центр
  • RegenOrthoSport — Hyderabad

Публикации

  • 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

Идентификаторы

NCT: NCT03011398 · RSI2015-REG01

Первоисточники (государственные реестры)

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