Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial

NCT04351087 | Completed Results FDA Device

• 1 other identifier: 2019H0448
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to conduct a randomized trial comparing the clinical outcomes of PRP (standard intervention) versus Microfragmented adipose tissue (investigational) for the treatment of knee osteoarthritis. Hypothesis: Both interventions will result in significant improvement in patient-reported outcomes. We hypothesize that Microfragmented adipose tissue will provide superior outcomes.

Conditions

Osteoarthritis, Knee; Microfragmented Adipose Tissue; Platelet-Rich Plasma

Outcome Measures

Primary Outcomes (1)

• KOOS Pain [Knee Injury and Osteoarthritis Outcome Score]

  The Knee injury and Osteoarthritis Outcome Pain Score \[KOOS questionnaire\] is a self-reported outcome measure assessing the patient's opinion about the pain in their knee. Standardized answer options are given \[5 Likert boxes\] and each question is assigned a score from 0 to 4. A normalized score \[100 indicating no pain and 0 indicating extreme pain\] is calculated.

  6 months

Secondary Outcomes (2)

• VAS [Visual Analog Pain Scale] Pain Score

  6 months

• Tegner Activity Scale

  6 months

Study Arms (2)

Platelet Rich Plasma

ACTIVE COMPARATOR

157cc of whole blood will be harvested via standard venipuncture from the antecubital fossa and mixed with 24cc ACD-A (manufacturer recommends 8cc ACD-A per 52cc of whole blood). 156ml of whole blood will be processed in the FDA Cleared Angel cPRP system at 2% hematocrit. 1ml of whole blood and the resultant PRP will be analyzed in the Sysmex XN-350 for complete analysis (platelet, leukocyte, red blood cell counts). The remaining PRP will be injected under sterile technique using ultrasound-guidance through a superolateral approach. For patient comfort, 2cc of 1% lidocaine can be administered using a 26-gauge needle (into soft tissues only). PRP will then be injected using a 25-guage needle. A maximum of 6ml of PRP will be injected. Injection site will be cleaned and bandaged and patient will be dismissed with post-injection precautions and 1 month follow-up scheduled.

Device: Platelet Rich Plasma

Microfragmented adipose tissue

ACTIVE COMPARATOR

Adipose is aspirated from the subcutaneous tissue of the buttock or abdomen. Aspiration site is injected with 10ml 1% lidocaine with epinephrine. A small poke incision is made with an 11-blade scalpel. Then 120ml of Klein solution is injected into the adipose tissue. Solution sits for 15 minutes to allow for adequate anesthesia. Aspiration cannula is inserted and moved in a back and forth motion for 2 minutes to allow for adipose aspiration. 30ml fat will be aspirated. Aspiration site is cleaned and bandaged. The aspirated fat is processed using the Lipogems system. 30ml of adipose is transferred to the device, saline is run through the device to remove oils and then approximately 5-7ml of adipose tissue is removed and ready for injection. The Microfragmented adipose tissue are then injected in identical fashion to the PRP above.

Device: Platelet Rich Plasma

Interventions

Platelet Rich Plasma DEVICE

Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance. Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.

Also known as: Microfragmented adipose tissue

Microfragmented adipose tissue; Platelet Rich Plasma

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25-75 years
• BMI \< 40
• Diagnosis of knee OA (primary and post-traumatic)
• Radiographic evidence of OA of the target knee (Kellgren-Lawrence grades 1-4)
• Continued OA pain in the target knee despite at least 6 weeks of 1 of the following nonoperative treatments: activity modification, weight loss attempt, physical therapy, or NSAID / acetaminophen.
• Knee Osteoarthritis Outcomes Score (KOOS)-Pain subscale 20-65
• Working knowledge of English language (to be able to complete all outcome scores)
• Ability to attend all follow-up appointments

You may not qualify if:

• Isolated patellofemoral OA
• + effusion of the target knee (stroke test grading system)
• Significant (10 degree) valgus or varus deformities
• Prior injection therapy:
• Steroid injection in target knee in the last 3 months
• Viscosupplementation in target knee in the last 6 months
• PRP in the target knee in the last 1 year
• No other cellular treatments in index knee (bone marrow, amniotic suspensions etc) all time
• Participation in any experimental device or drug study within 1 year before screening visit
• Oral or IM steroids for last 3 months
• Medical condition that may impact outcomes of procedure including:
• anemia
• thrombocytopenia
• bleeding disorders
• inflammatory disorders like rheumatoid arthritis, lupus

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Sports Medicine Center

Columbus, Ohio, 43221, United States

Location

Related Publications (16)

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  PMID: 24553908 BACKGROUND

• Hermann W, Lambova S, Muller-Ladner U. Current Treatment Options for Osteoarthritis. Curr Rheumatol Rev. 2018;14(2):108-116. doi: 10.2174/1573397113666170829155149.

  PMID: 28875826 BACKGROUND

• Liu Q, Niu J, Huang J, Ke Y, Tang X, Wu X, Li R, Li H, Zhi X, Wang K, Zhang Y, Lin J. Knee osteoarthritis and all-cause mortality: the Wuchuan Osteoarthritis Study. Osteoarthritis Cartilage. 2015 Jul;23(7):1154-7. doi: 10.1016/j.joca.2015.03.021. Epub 2015 Mar 25.

  PMID: 25819581 BACKGROUND

• Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22.

  PMID: 28012636 BACKGROUND

• Marx RE. Platelet-rich plasma (PRP): what is PRP and what is not PRP? Implant Dent. 2001;10(4):225-8. doi: 10.1097/00008505-200110000-00002. No abstract available.

  PMID: 11813662 BACKGROUND

• Moussa M, Lajeunesse D, Hilal G, El Atat O, Haykal G, Serhal R, Chalhoub A, Khalil C, Alaaeddine N. Platelet rich plasma (PRP) induces chondroprotection via increasing autophagy, anti-inflammatory markers, and decreasing apoptosis in human osteoarthritic cartilage. Exp Cell Res. 2017 Mar 1;352(1):146-156. doi: 10.1016/j.yexcr.2017.02.012. Epub 2017 Feb 13.

  PMID: 28202394 BACKGROUND

• Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21.

  PMID: 28146403 BACKGROUND

• Gormeli G, Gormeli CA, Ataoglu B, Colak C, Aslanturk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):958-965. doi: 10.1007/s00167-015-3705-6. Epub 2015 Aug 2.

  PMID: 26233594 BACKGROUND

• Sanchez M, Fiz N, Azofra J, Usabiaga J, Aduriz Recalde E, Garcia Gutierrez A, Albillos J, Garate R, Aguirre JJ, Padilla S, Orive G, Anitua E. A randomized clinical trial evaluating plasma rich in growth factors (PRGF-Endoret) versus hyaluronic acid in the short-term treatment of symptomatic knee osteoarthritis. Arthroscopy. 2012 Aug;28(8):1070-8. doi: 10.1016/j.arthro.2012.05.011.

  PMID: 22840987 BACKGROUND

• 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.

  PMID: 26831629 BACKGROUND

• De Francesco F, Ricci G, D'Andrea F, Nicoletti GF, Ferraro GA. Human Adipose Stem Cells: From Bench to Bedside. Tissue Eng Part B Rev. 2015 Dec;21(6):572-84. doi: 10.1089/ten.TEB.2014.0608. Epub 2015 Jun 17.

  PMID: 25953464 BACKGROUND

• Dragoo JL, Chang W. Arthroscopic Harvest of Adipose-Derived Mesenchymal Stem Cells From the Infrapatellar Fat Pad. Am J Sports Med. 2017 Nov;45(13):3119-3127. doi: 10.1177/0363546517719454. Epub 2017 Aug 17.

  PMID: 28816507 BACKGROUND

• Russo A, Condello V, Madonna V, Guerriero M, Zorzi C. Autologous and micro-fragmented adipose tissue for the treatment of diffuse degenerative knee osteoarthritis. J Exp Orthop. 2017 Oct 3;4(1):33. doi: 10.1186/s40634-017-0108-2.

  PMID: 28975547 BACKGROUND

• Russo A, Screpis D, Di Donato SL, Bonetti S, Piovan G, Zorzi C. Autologous micro-fragmented adipose tissue for the treatment of diffuse degenerative knee osteoarthritis: an update at 3 year follow-up. J Exp Orthop. 2018 Dec 19;5(1):52. doi: 10.1186/s40634-018-0169-x.

  PMID: 30569417 BACKGROUND

• Baria M, Barker T, Durgam S, Pedroza A, Flanigan D, Jia L, Kaeding C, Magnussen R. Microfragmented Adipose Tissue Is Equivalent to Platelet-Rich Plasma for Knee Osteoarthritis at 12 Months Posttreatment: A Randomized Controlled Trial. Orthop J Sports Med. 2024 Mar 18;12(3):23259671241233916. doi: 10.1177/23259671241233916. eCollection 2024 Mar.

  PMID: 38510323 DERIVED

• Baria M, Pedroza A, Kaeding C, Durgam S, Duerr R, Flanigan D, Borchers J, Magnussen R. Platelet-Rich Plasma Versus Microfragmented Adipose Tissue for Knee Osteoarthritis: A Randomized Controlled Trial. Orthop J Sports Med. 2022 Sep 16;10(9):23259671221120678. doi: 10.1177/23259671221120678. eCollection 2022 Sep.

  PMID: 36147791 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Michael Baria
• Organization: The Ohio State University

michael.baria@osumc.edu

614-293-8196

Study Officials

• Michael Baria, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two-treatment parallel-design

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 17, 2020
• Study Start: March 3, 2020
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: August 9, 2024
• Results First Posted: June 27, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)