Use of Bone Marrow to reduce pain and improve mobility in Hip Osteoarthritis

Clinical efficacy of Intra-articular Injection of Bone Marrow Aspirate (BMA) and Bone Marrow Concentrate (BMAC) in the treatment of Hip Osteoarthritis: a triple-blind, randomized, controlled clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-3yxrgtz

Enrollment

Unknown

Registered

2025-12-17

Start date

2026-01-05

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Hip

Interventions

All 103 patients who meet the inclusion criteria and have signed the Free and Informed Consent Form will undergo the collection of Bone Marrow Aspirate from the posterior iliac crest, under local anes

Bone Marrow Aspirate Concentrate Group: Composed of 34 patients who will receive an injection of 5 mL of Bone Marrow Cell Concentrate obtained by centrifugation of the Autologous Aspirate

Control Group: Composed of 34 patients who will receive an injection of 1 mL of triamcinolone 20 mg/mL, associated with 4 mL of 1% lidocaine. This is a randomized, controlled, triple-blind clinical tr

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteers; both genders; age of 18 years or older; with a confirmed diagnosis of hip osteoarthritis Tönnis grades 1 or 2; pain score greater than or equal to 4 on the visual analog scale; duration of visual analog scale pain for a minimum of 3 months; failure of previous conservative treatment

Exclusion criteria

Exclusion criteria: History of previous surgeries on the affected hip; previous episodes of joint infection; immunocompromiseds diagnosed with active autoimmune diseases; coagulation disorders diagnosis; predominant presence of neuropathic pain with a score greater than or equal to 4 on the Douleur Neuropathique 4 (DN4) questionnaire

Design outcomes

Primary

Measure	Time frame
Evaluate pain using the Visual Analog Scale before the injection, at the 1st month and 12th month after the injection, conducted in person, and at the 3rd month and 6th month after the injection, conducted via telephone follow-up;Evaluate functionality, through a self-report questionnaire: Hip Outcome Score (HOS) or HOS-Brazil, the validated Brazilian version of the Hip Disability and Osteoarthritis Outcome Score; before the injection, at the 1st month and 12th month after the injection, in person, and at the 3rd month and 6th month after the injection, via telephone follow-up; and through the functional test Timed Up and Go (TUG): before the injection, at the 1st month and at the 12th month after the injection, in person	—

Measure

Time frame

Evaluate pain using the Visual Analog Scale before the injection, at the 1st month and 12th month after the injection, conducted in person, and at the 3rd month and 6th month after the injection, conducted via telephone follow-up;Evaluate functionality, through a self-report questionnaire: Hip Outcome Score (HOS) or HOS-Brazil, the validated Brazilian version of the Hip Disability and Osteoarthritis Outcome Score; before the injection, at the 1st month and 12th month after the injection, in person, and at the 3rd month and 6th month after the injection, via telephone follow-up; and through the functional test Timed Up and Go (TUG): before the injection, at the 1st month and at the 12th month after the injection, in person

—

Secondary

Measure	Time frame
Evaluate quality of life using the Short Form Health Survey (SF-12); before the injection, at the 1st month and 12th month, in person; at the 3rd month and 6th month, via telephone follow-up;Evaluate safety and adverse events by monitoring for pain at the puncture site, infection, hematoma, systemic reactions, and worsening of joint pain at 1st montg and 12th month after the injection, in-person; at 3rd month and 6 month after the injection, via telephone follow-up;Evaluate patient's satisfaction with the treatment received using theLikert Scale at the 12th month after the injection, in-person	—

Measure

Time frame

Evaluate quality of life using the Short Form Health Survey (SF-12); before the injection, at the 1st month and 12th month, in person; at the 3rd month and 6th month, via telephone follow-up;Evaluate safety and adverse events by monitoring for pain at the puncture site, infection, hematoma, systemic reactions, and worsening of joint pain at 1st montg and 12th month after the injection, in-person; at 3rd month and 6 month after the injection, via telephone follow-up;Evaluate patient's satisfaction with the treatment received using theLikert Scale at the 12th month after the injection, in-person

—

Countries

Brazil

Contacts

Public ContactWalter Ricioli Junior

Santa Casa de Misericórdia de São Paulo

dot.quadril@hotmail.com+55(11)2176-1545

Outcome results

None listed

Source: REBEC (via WHO ICTRP)