[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438503":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":48,"responsibleParty":67,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":26,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":96,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bone marrow aspirate concentrate","EXPERIMENTAL","Bone marrow that is aspirated then concentrated using a device.",[13],"Combination Product: Aspire Needle + Emcyte PureBMC",{"label":15,"type":16,"description":17,"interventionNames":18},"Triamcinolone","ACTIVE_COMPARATOR","Triamcinolone is a corticosteroid.",[19],"Drug: Triamcinolone",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","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.",[9],null,{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":26},"DRUG","40 mg (1 mL) triamcinolone and 4 cc of lidocaine 1% that will be injected into the hip.",[15],[32,36],{"name":33,"affiliation":34,"role":35},"LEONARDO P OLIVEIRA, MD","Cleveland Clinic Florida","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":34,"role":38},"Carlos Higuera-Rueda, MD","STUDY_DIRECTOR",[40,44],{"name":33,"role":41,"phone":42,"phoneExt":26,"email":43},"CONTACT","(954)659-5430","oliveil@ccf.org",{"name":45,"role":41,"phone":46,"phoneExt":26,"email":47},"Zoe Healy, MS","(954)659-6152","Healyz@ccf.org",[49],{"facility":34,"status":26,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Weston","Florida","33331","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-80.39977,26.10037,{"lat":59,"lon":58},[62,65],{"name":63,"role":41,"phone":64,"phoneExt":26,"email":43},"Leonardo Oliveira, MD","954-659-5430",{"name":45,"role":41,"phone":66,"phoneExt":26,"email":47},"(954) 659-6152",{"type":35,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"LEONARDO OLIVEIRA","Principal Investigator",[71],{"name":72,"class":73},"Lisa Dean Moseley Foundation","UNKNOWN","100438503","phase-3-bone-marrow-aspirate-concentrate-versus-triamcinolone-injection-for-hip-osteoarthritis-100438503",false,"NCT04990128","Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis","Randomized Trial on the Evaluation of the Effectiveness of One Single Bone Marrow Aspirate Hip Injection Versus Triamcinolone for Hip Osteoarthritis","Inclusion:\n\n1. Provision of signed and dated consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged between 18 - 75 years old\n4. WOMAC Pain Subscale Total Score of 5 or higher in the Likert Scale (total score is 20)\n5. Kellgren-Lawrence Grade ≥ 2 on Hip X-Rays\n6. Body Mass Index ≤ 35 kg\u002Fm\\^2\n7. Unilateral or Bilateral Hip Osteoarthritis\n8. Prior physical therapy treatment for 6 weeks in the last 12 months and compliance with home exercise program\n9. Agreement to adhere to Lifestyle Considerations\n10. Discontinuation of pain\u002Fanti-inflammatory medications 2 week prior to baseline measurements\n11. Patients with cancer in remission for at least 5 years. Specific cancers which were treated with surgical resection and are not undergoing chemotherapy\u002Fradiation 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\n12. Negative gram stain result\n\nExclusion:\n\n1. Prior corticosteroid injection to the hip\n2. History of hip replacement(s)\n3. Noncompliance to preventive screening tests for cancer indicated by age\n4. Active autoimmune disease\n5. Current use of oral corticosteroid\n6. Use of immunosuppressive medications, or who are known to me immunocompromised\n7. Inability to be weaned of oral anti-inflammatory medications\n8. History of Diabetes or HbA1c ≥ 6.5%\n9. Uncontrolled Thyroid Dysfunction: 0.450 uIU\u002FmL ≥ TSH levels ≥ 4.500 uIU\u002FmL\n10. Vitamin D Level \\\u003C 30 ng\u002Fml\n11. Anemia (Hgb \\\u003C 11.7 g\u002FdL for Women; Hgb \\\u003C 13 g\u002FdL for men)\n12. eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m\\^2\n13. Thrombocytopenia with platelet count less than 150,000 x 10\\^9 L\n14. Patients with coagulopathies based on known clotting disorder\n15. Patients currently on anti-coagulation therapies\n16. Patients who report any active infection(s) including cellulitis, TB, HIV, COVID, Hepatitis B and C\n17. Moving over the next year\n18. Inability to consent to the research study\n19. Inability to complete forms electronically\n20. Subjects in any other clinical trials\n21. History of allergic reaction to lidocaine\n22. Pregnancy or planning to be pregnant during trial\n23. Breastfeeding","ALL","18 Years","75 Years",{"count":85,"type":86},100,"ESTIMATED","INTERVENTIONAL",[89],"PHASE3","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:\n\nSpecific 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).\n\nHypothesis: 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.\n\nSpecific 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).\n\nHypothesis: 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.\n\nSpecific Aim 3: Quantify and correlate cell characterization with patient reported outcomes score.\n\nHypothesis: The investigators hypothesize that there will be better patient reported outcomes in patients who have a higher concentration of mesenchymal stem cells injected.\n\nThe 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, 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.\n\nPatients 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.",[92],"Hip Osteoarthritis",[94,95],"bone marrow aspirate concentrate","triamcinolone","NOT_YET_RECRUITING","2026-06-09",{"date":99,"type":100},"2026-06-11","ACTUAL",{"date":102,"type":86},"2026-06-23",{"date":104,"type":86},"2027-11",{"name":5,"class":6},1]