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clinical Response of Joint Infiltration in Hip Osteoarthritis with Orthobiologics

Joint Infiltration in Hip Osteoarthritis with Bone Marrow Aspiration: randomized clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-8zwgpyg
Enrollment
Unknown
Registered
2024-03-21
Start date
2024-02-05
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Osteoarthritis, hip

Interventions

This is a randomized, controlled, single-blind clinical trial in which 54 individuals (with unilateral or bilateral involvement) with hip osteoarthritis in grades I to III according to the Kellgren-La

Sponsors

Fundação Universidade Federal de Sergipe
Lead Sponsor
Fundação Universidade Federal de Sergipe
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals who have had pain or swelling in the hip (symptoms relevant to hip joint pain) for at least 4 months; Kellgren-Lawrence grade between 1 and 3 on radiographic evaluation; over 18 years old; both genders

Exclusion criteria

Exclusion criteria: Patients who have undergone a corticosteroid hip joint infiltration within 3 months; or a Hialuronic Acid -HA joint infiltration within 6 months or history of any of the following medical conditions:diabetes, autoimmune disorders, disorders that require immunosuppression, rheumatoid arthritis, infectious arthritis, history of cancer, neurological condition that compromises gait or any other that compromises the level of consciousness, ongoing infectious diseases, kidney and liver diseases and osteonecrosis of the femoral head with collapse secondary to sickle cell anemia

Design outcomes

Primary

MeasureTime frame
Assess pain intensity and improvement in function with the application of specific questionnaires for osteoarthritis: Western Ontario and McMaster Universities and the Harris Hip Score;Assess pain using the visual analogue scale and algometer

Secondary

MeasureTime frame
Relate the improvement in pain level and functional improvement with the individual's general satisfaction at 1,3,6 and 12 months post intervention Parameter used: likert scale, in which we will establish post-infiltration satisfaction levels;Identify clinical complications in infiltrations with hyaluronic acid alone and its association with bone marrow aspirate Parameter used: a post-infiltration questionnaire will be applied to identify the onset of any new symptoms, or clinical worsening at 4 moments (1 month, 3 months, 6 months and 01 year post-infiltration) ;Evaluate joint and systemic inflammatory behavior after joint infiltration Parameter used: measurement of laboratory inflammatory markers (pro-inflammatory and anti-inflammatory cytokines, erythrocyte sedimentation rate, C-reactive protein, Ferritin) at 3 moments: 30 days pre-intervention, 30 and 90 days post-intervention;Assess joint inflammatory activity with increased temperature in the anterior region of the hip Parameter used: thermal camera (Seek Thermal Compact Pro, Moscow, Russia) with a resolution of 320 x 240 pixels and a temperature range of -4 to 330 Celsius degrees at a distance of 0.91 meter to 5.48 meters The body region of interest is the frontal hip region We expect to find lower temperature recording with thermographic captures in the evaluations of patients undergoing infiltration with the association of orthobiologicals (bone marrow aspirate with hyaluronic acid);Assess muscle strength in flexion and abduction movements at 1,3,6 and 12 months post intervention Parameter used: The maximum isometric force, the rate of force development will be determined by a Chronojump load cell (Chronojump, BoscoSystem, Barcelona, ??Spain), with a capacity of 500 kg To attach the equipment to the evaluation table, Spider Simond carabiners (Simond, Charmonix, France) will be used

Countries

Brazil

Contacts

Public ContactMichael Santiago

Fundação Universidade Federal de Sergipe

michael.santiago@ebserh.gov.br+55(79)31947208

Outcome results

None listed

Source: REBEC (via WHO ICTRP)