Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis

NCT04990128 | Not Yet Recruiting Phase 3 DMC FDA Device

• 2 other identifiers: FLA 21-020IDE 27066
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single site, randomized single blinded, two arm study researching the effects of bone marrow aspirate concentrate (BMAC) versus Triamcinolone in patients with hip osteoarthritis. The aims and hypothesis are as follows: Specific Aim 1: Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months). Hypothesis: The investigators hypothesize that triamcinolone and BMAC groups will have pain reduction after each respective intervention. The changes with triamcinolone will be noticeable on the short term. The BMAC changes will take longer to have an effect but will longer duration. The investigators hypothesize that at 6 months and 1 year participants receiving BMAC will have better scores reported on the WOMAC compared to the triamcinolone injection and better than prior to injection. Specific Aim 2: Evaluate the change of bone marrow aspirate injection in comparison to triamcinolone in participant's performance on the 6 minute walk test from baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months). Hypothesis: The investigators hypothesize that there will be higher walking distances on the 6 minute walk test in the participants receiving a BMAC injection in comparison to triamcinolone starting at the 3 months follow-up time. Specific Aim 3: Quantify and correlate cell characterization with patient reported outcomes score. Hypothesis: The investigators hypothesize that there will be better patient reported outcomes in patients who have a higher concentration of mesenchymal stem cells injected. The investigators will enroll 50 patients into each arm. Bone marrow will be aspirated then subsequently concentrated using the Emcyte PureBMC kit. The investigators will test the BMAC viability, rapid sterility, endotoxin, platelet concentration, volume, and total nucleated cell counts prior to injecting. The BMAC will be utilized as a hip injection into the affected hip of the patient. Patients receiving the Triamcinolone will undergo a sham bone needling to simulate the aspiration to keep patients blinded. Both groups will receive their injections under ultrasound guidance.

Conditions

Hip Osteoarthritis

Keywords

bone marrow aspirate concentrate; triamcinolone

Outcome Measures

Primary Outcomes (4)

• Western Ontario McMaster Universities Arthritis Index (WOMAC)

  WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 6 weeks.

• Western Ontario McMaster Universities Arthritis Index (WOMAC)

  WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 3 months.

• Western Ontario McMaster Universities Arthritis Index (WOMAC)

  WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 6 months.

• Western Ontario McMaster Universities Arthritis Index (WOMAC)

  WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months.

Secondary Outcomes (4)

• 6 Minute Walk Test (6MWT)

  Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 6 weeks.

• 6 Minute Walk Test (6MWT)

  Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 3 months.

• 6 Minute Walk Test (6MWT)

  Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 6 months.

• 6 Minute Walk Test (6MWT)

  Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months.

Other Outcomes (16)

• PROMIS - Physical Function (PROMIS-PF)

  Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 6 weeks.

• PROMIS - Physical Function (PROMIS-PF)

  Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 3 months.

• PROMIS - Physical Function (PROMIS-PF)

  Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 6 months.

Study Arms (2)

Bone marrow aspirate concentrate

EXPERIMENTAL

Bone marrow that is aspirated then concentrated using a device.

Combination Product: Aspire Needle + Emcyte PureBMC

Triamcinolone

ACTIVE COMPARATOR

Triamcinolone is a corticosteroid.

Drug: Triamcinolone

Interventions

Triamcinolone DRUG

40 mg (1 mL) triamcinolone and 4 cc of lidocaine 1% that will be injected into the hip.

Triamcinolone

Aspire Needle + Emcyte PureBMC COMBINATION_PRODUCT

The Aspire Needle will be utilized to extract the bone marrow and the Emcyte PureBMC will be used to concentrate bone marrow aspirate. The final concentrate will be injected into the hip.

Bone marrow aspirate concentrate

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged between 18 - 75 years old
• WOMAC Pain Subscale With Average Score(Total WOMAC Pain Score Divided by 5) Equal to 4 or higher
• Kellgren-Lawrence Grade greater than or equal to 2 on Hip X-Rays
• Body Mass Index less than or equal to 35 kg/m2
• Unilateral or Bilateral Hip Osteoarthritis
• Prior physical therapy treatment for 6 weeks in the last 6 months
• Agreement to adhere to Lifestyle Considerations (see section 5.3)
• Discontinuation of pain/anti-inflammatory medications 2 week prior to baseline measurements
• Patients with cancer in remission for at least 5 years. Specific cancers which were treated with surgical resection and are not undergoing chemotherapy/radiation therapy such as breast cancer, colon cancer, or skin cancer, and others could participate when deemed in remission for 1 year. Written approval from oncologist will be necessary prior to enrollment
• Endotoxin less than or equal to 0.5 EU/ml
• Negative gram stain result

You may not qualify if:

• Prior corticosteroid injection to the hip
• History of hip replacement(s)
• Noncompliance to preventive screening tests for cancer indicated by age
• Active autoimmune disease
• Current use of oral corticosteroid
• Use of immunosuppressive medications, or who are known to me immunocompromised
• Inability to be weaned of oral anti-inflammatory medications
• History of Diabetes or HbA1c \> 6.5%
• Uncontrolled Thyroid Dysfunction: 0.450 uIU/mL ≥ TSH levels ≥ 4.500 uIU/mL
• Vitamin D Level \< 30 ng/ml
• Anemia (Hgb \< 11.7 g/dL for Women; Hgb \< 13 g/dL for men)
• eGFR \< 60 mL/min/1.73 m2
• Thrombocytopenia with platelet count less than 150,000 x 109 L
• Patients with coagulopathies based on known clotting disorder
• Patients currently on anti-coagulation therapies

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Lisa Dean Moseley Foundation: collaborator

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (22)

• Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.

  PMID: 24553908 BACKGROUND

• Hootman JM, Helmick CG, Barbour KE, Theis KA, Boring MA. Updated Projected Prevalence of Self-Reported Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation Among US Adults, 2015-2040. Arthritis Rheumatol. 2016 Jul;68(7):1582-7. doi: 10.1002/art.39692.

  PMID: 27015600 BACKGROUND

• Duclos M. Osteoarthritis, obesity and type 2 diabetes: The weight of waist circumference. Ann Phys Rehabil Med. 2016 Jun;59(3):157-160. doi: 10.1016/j.rehab.2016.04.002. Epub 2016 May 19.

  PMID: 27211819 BACKGROUND

• Courties A, Sellam J. Osteoarthritis and type 2 diabetes mellitus: What are the links? Diabetes Res Clin Pract. 2016 Dec;122:198-206. doi: 10.1016/j.diabres.2016.10.021. Epub 2016 Nov 5.

  PMID: 27889689 BACKGROUND

• Quinn RH, Murray J, Pezold R, Hall Q. Management of Osteoarthritis of the Hip. J Am Acad Orthop Surg. 2018 Oct 15;26(20):e434-e436. doi: 10.5435/JAAOS-D-18-00351.

  PMID: 30134309 BACKGROUND

• Kruse DW. Intraarticular cortisone injection for osteoarthritis of the hip. Is it effective? Is it safe? Curr Rev Musculoskelet Med. 2008 Dec;1(3-4):227-33. doi: 10.1007/s12178-008-9029-0.

  PMID: 19468910 BACKGROUND

• Hashmi SK. Basics of Hematopoietic Cell Transplantation for Primary Care Physicians and Internists. Prim Care. 2016 Dec;43(4):693-701. doi: 10.1016/j.pop.2016.07.003.

  PMID: 27866586 BACKGROUND

• Charlesworth J, Fitzpatrick J, Perera NKP, Orchard J. Osteoarthritis- a systematic review of long-term safety implications for osteoarthritis of the knee. BMC Musculoskelet Disord. 2019 Apr 9;20(1):151. doi: 10.1186/s12891-019-2525-0.

  PMID: 30961569 BACKGROUND

• Walters MC. Update of hematopoietic cell transplantation for sickle cell disease. Curr Opin Hematol. 2015 May;22(3):227-33. doi: 10.1097/MOH.0000000000000136.

  PMID: 25767957 BACKGROUND

• Kim GB, Seo MS, Park WT, Lee GW. Bone Marrow Aspirate Concentrate: Its Uses in Osteoarthritis. Int J Mol Sci. 2020 May 2;21(9):3224. doi: 10.3390/ijms21093224.

  PMID: 32370163 BACKGROUND

• Shapiro SA, Kazmerchak SE, Heckman MG, Zubair AC, O'Connor MI. A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. Am J Sports Med. 2017 Jan;45(1):82-90. doi: 10.1177/0363546516662455. Epub 2016 Sep 30.

  PMID: 27566242 BACKGROUND

• Rodriguez-Fontan F, Piuzzi NS, Kraeutler MJ, Pascual-Garrido C. Early Clinical Outcomes of Intra-Articular Injections of Bone Marrow Aspirate Concentrate for the Treatment of Early Osteoarthritis of the Hip and Knee: A Cohort Study. PM R. 2018 Dec;10(12):1353-1359. doi: 10.1016/j.pmrj.2018.05.016. Epub 2018 May 29.

  PMID: 29857166 BACKGROUND

• Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44.

  PMID: 26058927 BACKGROUND

• McIntyre JA, Jones IA, Han B, Vangsness CT Jr. Intra-articular Mesenchymal Stem Cell Therapy for the Human Joint: A Systematic Review. Am J Sports Med. 2018 Dec;46(14):3550-3563. doi: 10.1177/0363546517735844. Epub 2017 Nov 3.

  PMID: 29099618 BACKGROUND

• Hernigou P, Trousselier M, Roubineau F, Bouthors C, Chevallier N, Rouard H, Flouzat-Lachaniette CH. Stem Cell Therapy for the Treatment of Hip Osteonecrosis: A 30-Year Review of Progress. Clin Orthop Surg. 2016 Mar;8(1):1-8. doi: 10.4055/cios.2016.8.1.1. Epub 2016 Feb 13.

  PMID: 26929793 BACKGROUND

• Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30. Erratum In: Int Orthop. 2018 Jan;42(1):223. doi: 10.1007/s00264-017-3680-2.

  PMID: 27026621 BACKGROUND

• Centeno CJ, Al-Sayegh H, Bashir J, Goodyear S, Freeman MD. A dose response analysis of a specific bone marrow concentrate treatment protocol for knee osteoarthritis. BMC Musculoskelet Disord. 2015 Sep 18;16:258. doi: 10.1186/s12891-015-0714-z.

  PMID: 26385099 BACKGROUND

• Piuzzi NS, Mantripragada VP, Sumski A, Selvam S, Boehm C, Muschler GF. Bone Marrow-Derived Cellular Therapies in Orthopaedics: Part I: Recommendations for Bone Marrow Aspiration Technique and Safety. JBJS Rev. 2018 Nov;6(11):e4. doi: 10.2106/JBJS.RVW.18.00007. No abstract available.

  PMID: 30461435 BACKGROUND

• Friedlis MF, Centeno CJ. Performing a Better Bone Marrow Aspiration. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):919-939. doi: 10.1016/j.pmr.2016.06.009.

  PMID: 27788908 BACKGROUND

• Rezende MU, Gurgel HMC, Ocampos GP, Campos GC, Frucchi R, Pailo AF, Pasqualin T, Vicente JRN, Camargo OP. IMPROVEMENTS IN HIP OSTEOARTHRITIS WITH LAVAGE, TRIAMCINOLONE AND HYLAN G-F20. Acta Ortop Bras. 2020 Nov-Dec;28(6):280-286. doi: 10.1590/1413-785220202806240075.

  PMID: 33328783 BACKGROUND

• Skwara A, Ponelis R, Tibesku CO, Rosenbaum D, Fuchs-Winkelmann S. Gait patterns after intraarticular treatment of patients with osteoarthritis of the knee--hyaluronan versus triamcinolone: a prospective, randomized, doubleblind, monocentric study. Eur J Med Res. 2009 Apr 16;14(4):157-64. doi: 10.1186/2047-783x-14-4-157.

  PMID: 19380288 BACKGROUND

• Martin RL, Philippon MJ. Evidence of reliability and responsiveness for the hip outcome score. Arthroscopy. 2008 Jun;24(6):676-82. doi: 10.1016/j.arthro.2007.12.011. Epub 2008 Mar 12.

  PMID: 18514111 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• LEONARDO P OLIVEIRA, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

• Carlos Higuera-Rueda, MD

  Cleveland Clinic Florida

  STUDY DIRECTOR

Central Study Contacts

LEONARDO P OLIVEIRA, MD

CONTACT

(954)659-5430; oliveil@ccf.org

Zoe Healy, MS

CONTACT

(954)659-6152; Healyz@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will undergo a sham bone needling if assigned to Triamcinolone group to keep patient blinded to their intervention. This will simulate the bone marrow aspiration process. Outcomes assessor will receive de-identified data including the treatment type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: bone marrow aspirate concentrate versus triamcinolone

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: August 4, 2021
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)