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Effect of intra-articular HA injection combined with infrapatellar fat pad TA injection on the improvement of knee pain and knee function in patients with osteoarthritis: a double-blind randomized controlled study

Effect of intra-articular HA injection combined with infrapatellar fat pad TA injection on the improvement of knee pain and knee function in patients with osteoarthritis: a double-blind randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105875
Enrollment
Unknown
Registered
2025-07-14
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Knee Osteoarthritis

Interventions

Experimental group:Intra-articular injection of hyaluronic acid and infrapatellar fat pad injection of triamcinolone acetonide
Control group1:Intra-articular injection of hyaluronic acid and infrapatellar fat pad injection of placebo
Control group2:Intra-articular injection of placebo and infrapatellar fat pad injection of triamcinolone acetonide

Sponsors

The First People's Hospital of Hefei
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Meet the American College of Rheumatology's clinical and radiographic criteria for diagnosing knee OA with knee pain (monthly pain >= 14 days prior to the start of the study, >= 3 months, 24-hour mean pain score (0-10) using the daily average of the pre-participation score) >= 4 points); 2. Patients with mild to moderate knee arthritis graded as grade 1, 2 and 3 according to KL; 3. Age greater than 40 years old; 4. Knee pain persisting for more than 6 months, and the pain (100 mm) assessed by VAS in the last week >= 40 mm; 5. MRI assessment of hoffa-synovitis score (MRI Osteoarthritis Knee score (MOAKS method) and effusion-synovitis score (MOAKS method) >=1, with a total score of >=3; 6. Body mass index (BMI) \u003C 40 kg/ m^2; 7. Knee stability, no knee deformity or lumbar spondylosis with radiculopathy; 8. Able to listen, speak, read and understand Chinese; Able to understand study requirements, collaborate with the investigators during the course of the study, and provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients with the following diseases or symptoms: 1. Glucocorticoid or hyaluronic acid injections in the knee joint within the past 6 months; 2. Received invasive knee treatment within the past 6 months; 3. Planned hip or knee surgery (including arthroscopy, arthroplasty and other open joint surgeries) within the next 6 months; 4. Metabolic disease or anticoagulation therapy; 5. History of allergy to any of the study drugs; 6. Have inflammatory arthritis, autoimmune disease, septic arthritis, or any other concomitant disease (such as liver and kidney disease); 7. End-stage knee osteoarthritis (KL grade 4); 8. History of knee arthroplasty or infection of the affected limb; 9. Contraindications to MRI (e.g., implantable pacemakers, artificial metal valves or corneas, aneurysm clipping surgery, arterial dissection, intraocular metallic foreign bodies, claustrophobia); 10. Malignant tumors or other life-threatening diseases; 11. Current use of oral corticosteroids; nonsteroidal anti-inflammatory drugs, or immunosuppressive drugs; 12. Pregnant or lactating females.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale (VAS) score;Infrapatellar fat pad thickness;

Secondary

MeasureTime frame
WOMAC;Knee Injury and Osteoarthritis Outcome Score (KOOS);

Countries

China

Contacts

Public ContactNing Rende

The First People's Hospital of Hefei

nrd1972@outlook.com+86 139 5696 6305

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026