Clinical trial NCT04711551: Clinical and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics
Official title: Patients-reported Outcome Measures (PROMs), Clinical Objective and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Musculoskeletal System Disease
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patients who received indication for regerative medicine treatment for one of the following pathologies: Knee or hip or ankle osteoarthritis, patellar or Achilles tendon pain, shouder or elbow pain;

Brief summary: the aim is to improve the evaluation of the outcomes of regenerative medicine treatments performed in the regenerative medicine centers involved in the study.

patients who undergo regenerative medicine treatments present acute and chronic pathologies of the musculoskeletal system, of the stomatological system and of the integuments.

Objective pre, peri and post treatment evaluations are collected. A dedicated software collects the PROMs compiled by the patients, the objective clinical data and the biomolecular evaluations.


Eligibility criteria: Inclusion Criteria:

* patients who received indication for regerative medicine treatment for one of the following pathologies: Knee or hip or ankle osteoarthritis, patellar or Achilles tendon pain, shouder or elbow pain;
* males and females;
* age \>= 6 years.

Exclusion Criteria:

* age \< 6 years
* patients not compliant with post-treatment monitoring procedures
* pregnancy

Primary outcomes:
measure: Change in Visual Analog Scale
timeFrame: Change between baseline and 12 months
Secondary outcomes:
measure: Change in Tegner Activity Scale
timeFrame: Changes between baseline and 2-, 6- 12 and 24-month assessments
measure: Change in Knee injury and Osteoarthritis Outcome Score for patients affected by knee osteoarthritis
timeFrame: Changes between baseline and 2-, 6- 12 and 24-month assessments
measure: Change in Hip injury and Osteoarthritis Outcome Score for patients affected by hip osteoarthritis
timeFrame: Changes between baseline and 2-, 6- 12 and 24-month assessments
measure: Change in QuickDASH (Disabilities of the Arm, Shoulder and Hand) and SPADI (Shoulder Pain and Disability Index ) questionnaire for patients affected by shoulder disorders
timeFrame: Changes between baseline and 2-, 6- 12 and 24-month assessments
measure: Change in the Shoulder Pain and Disability Index (SPADI) for patients affected by shoulder disorders
timeFrame: Changes between baseline and 2-, 6- 12 and 24-month assessments
measure: Change in Victorian Institute of Sport Assessment for Patellar tendon (VISA-P) score for patients affected by patellar tendon disorders
timeFrame: Changes between baseline and 2-, 6- 12 and 24-month assessments
measure: Change in Lysholm Knee Score for patients affected by patellar tendon disorders
timeFrame: Changes between baseline and 2-, 6- 12 and 24-month assessments
measure: Change in Foot Function Index (FFI) for patients affected by ankle and foot disorders
timeFrame: Changes between baseline and 2-, 6- 12 and 24-month assessments
measure: Change in Victorian Institute of Sport Assessment for Achilles tendon (VISA-A) score for patients affected by Achilles tendon disorders
timeFrame: Changes between baseline and 2-, 6- 12 and 24-month assessments
measure: Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) scale for patients affected by elbow disorders
timeFrame: Changes between baseline and 2-, 6- 12 and 24-month assessments
measure: Platelet count in Platelet-rich Plasma (PRP)
timeFrame: Baseline only
measure: Nucleated cell counts in adipose tissue- and bone marrow-derived orthobiologics
timeFrame: Baseline only
measure: Change in Visual Analog Scale
timeFrame: Changes between baseline and 2-, 6- and 24-month assessments
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Clinico San Siro (satellite center)
state: Italia
city: Milan
country: Italy
facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio (coordinator)
Study officials:
affiliation: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
name: Laura De Girolamo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazzocca AD, McCarthy MB, Chowaniec DM, Dugdale EM, Hansen D, Cote MP, Bradley JP, Romeo AA, Arciero RA, Beitzel K. The positive effects of different platelet-rich plasma methods on human muscle, bone, and tendon cells. Am J Sports Med. 2012 Aug;40(8):1742-9. doi: 10.1177/0363546512452713. Epub 2012 Jul 16.
citation: Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.
citation: Kern S, Eichler H, Stoeve J, Kluter H, Bieback K. Comparative analysis of mesenchymal stem cells from bone marrow, umbilical cord blood, or adipose tissue. Stem Cells. 2006 May;24(5):1294-301. doi: 10.1634/stemcells.2005-0342. Epub 2006 Jan 12.
citation: Strioga M, Viswanathan S, Darinskas A, Slaby O, Michalek J. Same or not the same? Comparison of adipose tissue-derived versus bone marrow-derived mesenchymal stem and stromal cells. Stem Cells Dev. 2012 Sep 20;21(14):2724-52. doi: 10.1089/scd.2011.0722. Epub 2012 May 9.
citation: Vishnubalaji R, Al-Nbaheen M, Kadalmani B, Aldahmash A, Ramesh T. Comparative investigation of the differentiation capability of bone-marrow- and adipose-derived mesenchymal stem cells by qualitative and quantitative analysis. Cell Tissue Res. 2012 Feb;347(2):419-27. doi: 10.1007/s00441-011-1306-3.
citation: Caplan AI, Correa D. The MSC: an injury drugstore. Cell Stem Cell. 2011 Jul 8;9(1):11-5. doi: 10.1016/j.stem.2011.06.008.
citation: Bosetti M, Borrone A, Follenzi A, Messaggio F, Tremolada C, Cannas M. Human Lipoaspirate as Autologous Injectable Active Scaffold for One-Step Repair of Cartilage Defects. Cell Transplant. 2016;25(6):1043-56. doi: 10.3727/096368915X689514. Epub 2015 Sep 21.
citation: Pak J, Lee JH, Park KS, Jeong BC, Lee SH. Regeneration of Cartilage in Human Knee Osteoarthritis with Autologous Adipose Tissue-Derived Stem Cells and Autologous Extracellular Matrix. Biores Open Access. 2016 Aug 1;5(1):192-200. doi: 10.1089/biores.2016.0024. eCollection 2016.
citation: Moatshe G, Morris ER, Cinque ME, Pascual-Garrido C, Chahla J, Engebretsen L, Laprade RF. Biological treatment of the knee with platelet-rich plasma or bone marrow aspirate concentrates. Acta Orthop. 2017 Dec;88(6):670-674. doi: 10.1080/17453674.2017.1368899. Epub 2017 Aug 23.
citation: Centeno C, Pitts J, Al-Sayegh H, Freeman M. Efficacy of autologous bone marrow concentrate for knee osteoarthritis with and without adipose graft. Biomed Res Int. 2014;2014:370621. doi: 10.1155/2014/370621. Epub 2014 Sep 7.