Knee Osteoarthritis(TFOA)
Conditions
Interventions
1:Intra-articular injection of hyaluronic acid and glucocorticoid, using Lidocaine as solution
2:Intra-articular injection of glucocorticoid, using Lidocaine as solution
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Ambulatory male or female; assistive devices (e.g. canes) were allowed 18 years; 3. BMI >= 20 kg/m2 and = 2 on at least one of the WOMAC weight bearing pain questions on the most days for at least one month; 5. Radiological criteria: X-rays showing tibiofemoral knee osteoarthritis defined as at least Kellgren and Lawrence Grade 2; 6. Relatively good health, with a score of 0 to 2 on a 5-point (Likert scale, with a range of 0 indicating very good health to 4 indicating very poor health), according to the investigators global assessment of disease status; 7. Have language skills and judgment sufficient to complete the outcome assessments and instruments; 8. Written consent before entering the project.
Exclusion criteria
Exclusion criteria: 1.Predominant lateral tibiofemoral disease; 2.NSAID treatment within 2 weeks/ oral corticosteroids within 4 weeks of baseline (week 0) visit or regular use of analgesics or anti-inflammatory drugs taken for conditions not related to knee pain; 3.Intra-articular injections of steroids, autologous blood products or other drugs within 3 months of baseline (week 0) visit; 4.Intra-articular injections of viscosupplementation (e.g. hyaluronic acid) within 6 months of baseline (week 0) visit 5.Infection diseases in the target knee within 1 year of baseline (week 0) visit; 6.Knee surgery on their most painful knee within past 12 months; 7.Secondary osteoarthritis caused by prior surgeries or other diseases in the target knee; 8.History of partial or total arthroplasty of the target knee; 9.Abnormal rheumatic immune indicators or other autoimmune diseases that affect knees (e.g. rheumatic diseases) ; 10.Joint microcrystalline arthropathies (e.g., gout or calcium pyrophosphatedeposition disease [CPPD]); 11.Symptomatic osteoarthritis in other lower limb joints (e.g. hip or ankle) homolateral to the target knee; 12.Serious concomitant medical conditions or impairments that, in the view of the investigator, would obstruct; participation in the trial, such as uncontrolled HIV infection, opiate dependency, severe coronary artery and peripheral vascular diseases, cancer, COPD, etc.; 13.Dermatological diseases at knee region contraindicating intra-articular injection; 14.Women who are pregnant or plan to get pregnant or breast-feeding in the project period; 15.Plan to permanently relocate from the region in the project period; 16.Strongly intent to perform knee reconstructive surgeries, arthroplasty or osteotomy in the project period; 17.Having comorbid conditions that have more regional pain (e.g. fibromyalgia) than the target knee or could affect pain assessment of the target knee (e.g. spinal nerve root compression syndromes) during daily activities of walking, standing, going up and down stairs, etc.; 18.Contraindications to MRI scanning (e.g., implanted pacemaker, metal sutures, presence of shrapnel or iron filings in the eye, claustrophobia, knee too large for coil); 19.Known intolerance or allergic to steroids or lidocaine, or other contraindications to their injections (e.g. severe or uncontrolled diabetes).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-week WOMAC pain subscale scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Rating of Change at all Follow-up Assessments score;knee structures;Tibiofemoral cartilage volume,thickness and cartilage defects scale assessments;WOMAC pain subscale scores at other time points;WOMAC stiffness and physical function subscales;WOMAC total scores;MRI Bone Marrow Lesion Measurements;20-m walk;Chair stand time;Concomitant Pain medication Use and Surgery; | — |
Countries
China
Contacts
Public ContactZhao Jinzhong
Shanghai Sixth People's Hospital
Outcome results
None listed