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Résztvevőt keres itt: Egyesült Államok3. fázis

Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis

A legfontosabb adatok

Ki végzi
The Cleveland Clinic
Hol
Weston (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toboroz
Fázis
3. fázis
Résztvevők
100 fő, tervezett
Kezdés
2026. aug. 28.
Várható befejezés
2027. dec.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Aspire Needle + Emcyte PureBMC
  • Triamcinolone
A regiszteradat frissítve
2026. szeptember 9.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with osteoarthritis in one or both hips. It compares a bone marrow concentrate injection with a triamcinolone injection.

Életkor
18 to 75 years
Nem
Male or female
A betegség stádiuma
Hip osteoarthritis of Kellgren-Lawrence Grade ≥ 2 on hip X-rays. WOMAC pain score of 5 or higher (out of 20). Body Mass Index ≤ 35 kg/m^2.
Korábbi kezelés
Must have had physical therapy for 6 weeks in the last 12 months and kept up home exercises. Must stop pain and anti-inflammatory medicines 2 week before baseline tests. Cannot join after a prior corticosteroid injection to the hip or a hip replacement. Past cancer must be in remission for at least 5 years, or 1 year for some cancers removed by surgery, with written oncologist approval.
Biomarker vagy leletérték
Negative gram stain result. Cannot join with HbA1c ≥ 6.5% (48 mmol/mol), Vitamin D < 30 ng/ml, eGFR < 60 mL/min/1.73 m^2, platelets below 150,000 x 10^9 L, or anemia (Hgb < 11.7 g/dL for women, < 13 g/dL for men).

A részvétel fő kizáró okai

  • Diabetes, active autoimmune disease, or a weak immune system or immune-lowering medicines
  • Current oral corticosteroids or blood thinners, or a known clotting disorder
  • Active infection such as cellulitis, TB, HIV, COVID, Hepatitis B or C
  • Uncontrolled thyroid problems (TSH outside 0.450 to 4.500 uIU/mL)
  • Pregnant, planning pregnancy, or breastfeeding

A regiszter feltételei, szó szerint

Mind a 36 feltétel megnézéseKevesebb

Egyéb feltételek

  • Inclusion:
  • 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 Total Score of 5 or higher in the Likert Scale (total score is 20)
  • Kellgren-Lawrence Grade ≥ 2 on Hip X-Rays
  • Body Mass Index ≤ 35 kg/m\^2
  • Unilateral or Bilateral Hip Osteoarthritis
  • Prior physical therapy treatment for 6 weeks in the last 12 months and compliance with home exercise program
  • Agreement to adhere to Lifestyle Considerations
  • 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
  • Negative gram stain result; Exclusion:
  • 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 m\^2
  • Thrombocytopenia with platelet count less than 150,000 x 10\^9 L
  • Patients with coagulopathies based on known clotting disorder
  • Patients currently on anti-coagulation therapies
  • Patients who report any active infection(s) including cellulitis, TB, HIV, COVID, Hepatitis B and C
  • Moving over the next year
  • Inability to consent to the research study
  • Inability to complete forms electronically
  • Subjects in any other clinical trials
  • History of allergic reaction to lidocaine
  • Pregnancy or planning to be pregnant during trial
  • Breastfeeding

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 75 év között vagy?

Helyszínek itt: Egyesült Államok

  • Cleveland Clinic FloridaWeston, Egyesült ÁllamokContact: Leonardo Oliveira, MDRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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:

A teljes eredeti leírásKevesebb

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, 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.

A vizsgálat 2 csoportja

  • Bone marrow aspirate concentrateA vizsgált kezelés

    Bone marrow that is aspirated then concentrated using a device.

    Kezelés: Aspire Needle + Emcyte PureBMC

  • TriamcinoloneMár használt kezelés, összehasonlításként

    Triamcinolone is a corticosteroid.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Randomized Trial on the Evaluation of the Effectiveness of One Single Bone Marrow Aspirate Hip Injection Versus Triamcinolone for Hip Osteoarthritis
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
Illeszkedési kérdések
Forrás: NCT04990128: ki vehet részt
A regiszteradat frissítve
2026. szeptember 9.