Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis
NCT ID: NCT04990128
Last Updated: 2025-12-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-01-15
Study Completion Date
2027-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection
NCT05985785
Osteoarthritis of the Knee
RECRUITING
NA
BMA vs Cortisone for Glenohumeral Osteoarthritis
NCT03580148
Osteo Arthritis Shoulders
COMPLETED
PHASE2/PHASE3
Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial
NCT04441112
Arthritis Knee
Arthritis of Hip
COMPLETED
PHASE2/PHASE3
Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection
NCT02126878
Bursitis
COMPLETED
NA
A Study to Evaluate an Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release in Subjects With Osteoarthritis of the Hip
NCT06977568
Osteoarthritis of Hip
TERMINATED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The goal of the study is to enroll 50 subjects in the bone marrow arm (BMAC group) and 50 in the triamcinolone arm (triamcinolone group). Once part fulfill the inclusion criteria, participants will be randomized to either intervention.
Participants will be enrolled in a staggering manner for the BMAC arm. The first 4 participants will be enrolled with at least 1 week interval in between these patients. During these weeks, the investigators will obtain results from the BMAC culture and evaluate safety response to the procedure. Participants enrolled in the triamcinolone arm will not be enrolled in a staggering manner, as the safety and efficacy are established as this is part of standard of care for hip osteoarthritis.
Participants will have the study protocol explained to them and will consent to the study, agreeing to have the bone marrow aspiration (BMA) and hip injection performed. Prior to any interventions, the participants will complete the baseline patient reported outcomes scores, and blood draw outlined in SOA section 1.3
Inclusion and exclusion criteria will be assessed during screening. Kellgren-Lawrence grade will be determined by blinded radiologists and co-investigators (Drs. Amer Hanano and Carl Winalski). An average score will be taken.
In order to blind the patient of the intervention, the triamcinolone group will undergo a "sham" bone needling of the bone cortex to simulate bone marrow harvesting (BMH). The posterior iliac spine will be anesthetized and needled simulating a BMH. Following the needling, the group will then receive a triamcinolone injection.
The process of aspirating the bone marrow used has been described by Dr. Friedlis and Dr. Centeno and will be completed under ultrasound guidance and in sterile fashion19. Multiple small draws of maximum 10 cc will be completed from different locations in the posterior superior iliac spine. The procedure as described is safe and been completed in more than 2000 individuals. Three to six passes are completed on each posterior superior iliac spine and a total volume of 60 cc of bone marrow is aspirated.
The BMAC group will have bone marrow aspirated using the Emcyte ASPIRE™ needle and subsequently concentrated using the Emcyte PureBMC™ system. Out of the bone aspirated, 60 cc will be utilized for concentration, 2 cc will be utilized by Bioscience Research Laboratory (BSR), and 2 cc will be stored in a -80°C biorepository enzyme-linked immunosorbent assay to determine concentrations of IL-1ra and other cytokines.
The 60 cc of unconcentrated bone marrow will then be concentrated to a total of 8 cc of concentrated bone marrow utilizing the Emcyte PureBMC™ system. Out of these 8 cc, 5 will be injected to the patient and the remainder 3 cc will be utilized for analyses.
These are the volumes and respective analyses:
* 1.5 cc will be directed to BSR for colony forming units, cell viability, total nucleated cell count as outlined in the subsequent paragaphs,
* 1 cc will be sent for 14 day culture
* 0.5 cc for endotoxin testing and gram stain
We will measure endotoxin concentrations utilizing the Charles River Nexgen PTS point of care instrument. The limit of endotoxin for general medical devices is 0.5 EU/mL. We will abide by this limit.
Rapid sterility will be assessed using a gram stain, performed by a CLIA certified laboratory at Cleveland Clinic Florida.
To ensure patient safety, patient will be considered a screen failure if there is a positive Gram stain or positive endotoxin testing. The injection of the BMAC will not be subsequently injected.
The remaining 5 cc will be utilized as the intervention group injectate. The BMAC will be injected as is and will not undergo any manipulation and/or dilution.
The 5 cc BMAC dose or 1 cc triamcinolone of 40 mg with 4 cc of lidocaine 1% will be injected into a single affected hip joint under ultrasound guidance.
Once the injection has been completed, patient will be monitored for 15 minutes and discharged home. Participants will be instructed to not use ice or anti-inflammatory medications for at least 6 weeks. For pain control following the procedure, the participant will be recommended to use acetaminophen or tramadol depending on the severity. Heat may be applied to the hip joint in case of muscle tightness. Ice should be avoided at the injection site. It may be applied at the site of bone marrow aspiration.
Participant will then follow-up in 6 weeks, 3 months, 6 months, and 1 year post-procedure to completed PROs and functional assessment with research staff. Participants will be asked to communicate to the Principal Investigator when anti-inflammatory medications are initiated, if necessary. Following the injections, both groups will resume home exercise program which participants had been completing prior to the injection in a pain free approach.
Participants will be enrolled in a staggering manner for the BMAC arm. The first 4 participants will be enrolled with at least 1 week interval in between these patients. During these weeks, the investigators will obtain results from the BMAC culture and evaluate safety response to the procedure. Participants enrolled in the triamcinolone arm will not be enrolled in a staggering manner, as the safety and efficacy are established as this is part of standard of care for hip osteoarthritis.
Participants will have the study protocol explained to them and will consent to the study, agreeing to have the bone marrow aspiration (BMA) and hip injection performed. Prior to any interventions, the participants will complete the baseline patient reported outcomes scores, and blood draw outlined in SOA section 1.3
Inclusion and exclusion criteria will be assessed during screening. Kellgren-Lawrence grade will be determined by blinded radiologists and co-investigators (Drs. Amer Hanano and Carl Winalski). An average score will be taken.
In order to blind the patient of the intervention, the triamcinolone group will undergo a "sham" bone needling of the bone cortex to simulate bone marrow harvesting (BMH). The posterior iliac spine will be anesthetized and needled simulating a BMH. Following the needling, the group will then receive a triamcinolone injection.
The process of aspirating the bone marrow used has been described by Dr. Friedlis and Dr. Centeno and will be completed under ultrasound guidance and in sterile fashion19. Multiple small draws of maximum 10 cc will be completed from different locations in the posterior superior iliac spine. The procedure as described is safe and been completed in more than 2000 individuals. Three to six passes are completed on each posterior superior iliac spine and a total volume of 60 cc of bone marrow is aspirated.
The BMAC group will have bone marrow aspirated using the Emcyte ASPIRE™ needle and subsequently concentrated using the Emcyte PureBMC™ system. Out of the bone aspirated, 60 cc will be utilized for concentration, 2 cc will be utilized by Bioscience Research Laboratory (BSR), and 2 cc will be stored in a -80°C biorepository enzyme-linked immunosorbent assay to determine concentrations of IL-1ra and other cytokines.
The 60 cc of unconcentrated bone marrow will then be concentrated to a total of 8 cc of concentrated bone marrow utilizing the Emcyte PureBMC™ system. Out of these 8 cc, 5 will be injected to the patient and the remainder 3 cc will be utilized for analyses.
These are the volumes and respective analyses:
* 1.5 cc will be directed to BSR for colony forming units, cell viability, total nucleated cell count as outlined in the subsequent paragaphs,
* 1 cc will be sent for 14 day culture
* 0.5 cc for endotoxin testing and gram stain
We will measure endotoxin concentrations utilizing the Charles River Nexgen PTS point of care instrument. The limit of endotoxin for general medical devices is 0.5 EU/mL. We will abide by this limit.
Rapid sterility will be assessed using a gram stain, performed by a CLIA certified laboratory at Cleveland Clinic Florida.
To ensure patient safety, patient will be considered a screen failure if there is a positive Gram stain or positive endotoxin testing. The injection of the BMAC will not be subsequently injected.
The remaining 5 cc will be utilized as the intervention group injectate. The BMAC will be injected as is and will not undergo any manipulation and/or dilution.
The 5 cc BMAC dose or 1 cc triamcinolone of 40 mg with 4 cc of lidocaine 1% will be injected into a single affected hip joint under ultrasound guidance.
Once the injection has been completed, patient will be monitored for 15 minutes and discharged home. Participants will be instructed to not use ice or anti-inflammatory medications for at least 6 weeks. For pain control following the procedure, the participant will be recommended to use acetaminophen or tramadol depending on the severity. Heat may be applied to the hip joint in case of muscle tightness. Ice should be avoided at the injection site. It may be applied at the site of bone marrow aspiration.
Participant will then follow-up in 6 weeks, 3 months, 6 months, and 1 year post-procedure to completed PROs and functional assessment with research staff. Participants will be asked to communicate to the Principal Investigator when anti-inflammatory medications are initiated, if necessary. Following the injections, both groups will resume home exercise program which participants had been completing prior to the injection in a pain free approach.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Hip Osteoarthritis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
bone marrow aspirate concentrate versus triamcinolone
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
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.
Outcomes assessor will receive de-identified data including the treatment type.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bone marrow aspirate concentrate
Bone marrow that is aspirated then concentrated using a device.
Group Type
EXPERIMENTAL
Aspire Needle + Emcyte PureBMC
Intervention Type
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.
Triamcinolone
Triamcinolone is a corticosteroid.
Group Type
ACTIVE_COMPARATOR
Triamcinolone
Intervention Type
DRUG
40 mg (1 mL) triamcinolone and 4 cc of lidocaine 1% that will be injected into the hip.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aspire Needle + Emcyte PureBMC
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.
Intervention Type
COMBINATION_PRODUCT
Triamcinolone
40 mg (1 mL) triamcinolone and 4 cc of lidocaine 1% that will be injected into the hip.
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Provision of signed and dated consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged between 18 - 75 years old
4. WOMAC Pain Subscale With Average Score(Total WOMAC Pain Score Divided by 5) Equal to 4 or higher
5. Kellgren-Lawrence Grade greater than or equal to 2 on Hip X-Rays
6. Body Mass Index less than or equal to 35 kg/m2
7. Unilateral or Bilateral Hip Osteoarthritis
8. Prior physical therapy treatment for 6 weeks in the last 6 months
9. Agreement to adhere to Lifestyle Considerations (see section 5.3)
10. Discontinuation of pain/anti-inflammatory medications 2 week prior to baseline measurements
11. 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
12. Endotoxin less than or equal to 0.5 EU/ml
13. Negative gram stain result
Exclusion:
1. Prior corticosteroid injection to the hip
2. History of hip replacement(s)
3. Noncompliance to preventive screening tests for cancer indicated by age
4. Active autoimmune disease
5. Current use of oral corticosteroid
6. Use of immunosuppressive medications, or who are known to me immunocompromised
7. Inability to be weaned of oral anti-inflammatory medications
8. History of Diabetes or HbA1c \> 6.5%
9. Uncontrolled Thyroid Dysfunction: 0.450 uIU/mL ≥ TSH levels ≥ 4.500 uIU/mL
10. Vitamin D Level \< 30 ng/ml
11. Anemia (Hgb \< 11.7 g/dL for Women; Hgb \< 13 g/dL for men)
12. eGFR \< 60 mL/min/1.73 m2
13. Thrombocytopenia with platelet count less than 150,000 x 109 L
14. Patients with coagulopathies based on known clotting disorder
15. Patients currently on anti-coagulation therapies
16. Patients who report any active infection(s) including cellulitis, TB, HIV, COVID, Hepatitis B and C
17. Moving over the next year
18. Inability to consent to the research study
19. Inability to complete forms electronically
20. Subjects in any other clinical trials
21. History of allergic reaction to lidocaine
22. Pregnancy or planning to be pregnant during trial
23. Breastfeeding
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged between 18 - 75 years old
4. WOMAC Pain Subscale With Average Score(Total WOMAC Pain Score Divided by 5) Equal to 4 or higher
5. Kellgren-Lawrence Grade greater than or equal to 2 on Hip X-Rays
6. Body Mass Index less than or equal to 35 kg/m2
7. Unilateral or Bilateral Hip Osteoarthritis
8. Prior physical therapy treatment for 6 weeks in the last 6 months
9. Agreement to adhere to Lifestyle Considerations (see section 5.3)
10. Discontinuation of pain/anti-inflammatory medications 2 week prior to baseline measurements
11. 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
12. Endotoxin less than or equal to 0.5 EU/ml
13. Negative gram stain result
Exclusion:
1. Prior corticosteroid injection to the hip
2. History of hip replacement(s)
3. Noncompliance to preventive screening tests for cancer indicated by age
4. Active autoimmune disease
5. Current use of oral corticosteroid
6. Use of immunosuppressive medications, or who are known to me immunocompromised
7. Inability to be weaned of oral anti-inflammatory medications
8. History of Diabetes or HbA1c \> 6.5%
9. Uncontrolled Thyroid Dysfunction: 0.450 uIU/mL ≥ TSH levels ≥ 4.500 uIU/mL
10. Vitamin D Level \< 30 ng/ml
11. Anemia (Hgb \< 11.7 g/dL for Women; Hgb \< 13 g/dL for men)
12. eGFR \< 60 mL/min/1.73 m2
13. Thrombocytopenia with platelet count less than 150,000 x 109 L
14. Patients with coagulopathies based on known clotting disorder
15. Patients currently on anti-coagulation therapies
16. Patients who report any active infection(s) including cellulitis, TB, HIV, COVID, Hepatitis B and C
17. Moving over the next year
18. Inability to consent to the research study
19. Inability to complete forms electronically
20. Subjects in any other clinical trials
21. History of allergic reaction to lidocaine
22. Pregnancy or planning to be pregnant during trial
23. Breastfeeding
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lisa Dean Moseley Foundation
UNKNOWN
Sponsor Role
collaborator
The Cleveland Clinic
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
LEONARDO OLIVEIRA
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
LEONARDO P OLIVEIRA, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Florida
Carlos Higuera-Rueda, MD
Role: STUDY_DIRECTOR
Cleveland Clinic Florida
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic Florida
Weston, Florida, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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.
Reference Type
BACKGROUND
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IDE 27066
Identifier Type: OTHER
Identifier Source: secondary_id
FLA 21-020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis
NCT02949466
UNKNOWN
PHASE4
Knee Injections for Obese Patients With Knee Arthritis
NCT06782529
RECRUITING
PHASE4
Ketorolac Versus Triamcinolone Knee Injections for Osteoarthritis
NCT02295189
COMPLETED
NA
The Efficacy of Intra-articular Triamcinolone Acetonide 5mg vs. 10 mg vs. 40 mg in Patients With Knee Osteoarthritis
NCT05806021
RECRUITING
PHASE4
Osteoarthritis Shoulder Injection Study
NCT03586687
TERMINATED
PHASE4
Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation
NCT01335321
COMPLETED
PHASE4
A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee
NCT02024529
COMPLETED
PHASE3
Additional Effects of Steroid and Dextrose to Hyaluronic Acid on Knee Osteoarthritis
NCT04165902
UNKNOWN
PHASE4
Intra-articular Tenoxicam Versus Triamcinolone Acetonide in Knee Osteoarthritis Management
NCT07194135
COMPLETED
NA
A Study of MEDI7352 in Painful Osteoarthritis of the Knee
NCT02508155
COMPLETED
PHASE1
Effect of Steroid Injections in a Knee With Osteoarthritis
NCT01230424
COMPLETED
PHASE4
INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE
NCT06700109
ACTIVE_NOT_RECRUITING
NA
Comparison of the Efficacy of Intra-articular Hybrid Hyaluronic Acid and Steroid in Patients With Rizoarthrosis
NCT03200886
UNKNOWN
Corticosteroid vs Platelet-Rich Plasma Intra-articular Injections in the Treatment of Knee Osteoarthritis.
NCT06032039
UNKNOWN
EARLY_PHASE1
Is Botox Effective in Relieving Pain From Knee Osteoarthritis?
NCT00279903
COMPLETED
PHASE1
Comparing Intra-articular Betamethasone (Diprospan) and Triamcinolone Acetonide Injection in Knee Osteoarthritis
NCT05139875
COMPLETED
PHASE4
Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis
NCT02576249
COMPLETED
PHASE4
Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis
NCT06279507
RECRUITING
PHASE4
Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis
NCT04238598
COMPLETED
NA
Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee
NCT02697773
COMPLETED
PHASE3
Additional Effect of Steroid on Hyaluronic Acid in Subdeltoid Bursitis
NCT06935877
NOT_YET_RECRUITING
PHASE4
Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
NCT01133613
COMPLETED
PHASE1
Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
NCT00809354
TERMINATED
PHASE3
Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)
NCT02095548
COMPLETED
PHASE1
Comparing Intra-articular Corticosteroid to Intra-articular Ketorolac Knee Injections
NCT02612272
UNKNOWN
PHASE4