Cartilage and biological changes in body after own blood product injection into joint and bone in Osteoarthritis knee : randomized controlled clinical trial

Not Applicable

Conditions: Health Condition 1: M170- Bilateral primary osteoarthritis of knee

Registration Number: CTRI/2019/10/021708

Lead Sponsor: Indian Council Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

The diagnosis of OA will be based on the American College of Rheumatology (ACR) criteria for OA Knee. Persons with OA Knee with the following features will be included in the study

1) OA Knee (Grade II/III, Radiological Kellgren and Lawrence (K/L) classification), age between 40-65 years and are able to walk with painful knee,

2)Having persisting knee pain >= 30mm on a 0-100mm VAS (when asked â??how painful is your knee during level walking?â??),

3)Willing to participate in all assessment

If both knees involved, participants may choose one or both knees to be treated.

Exclusion Criteria

Persons with OA Knee with following features will be excluded from the study

1.Severe OA Knee (Grade IV, K/L classification)

2.Haemoglobin level < 10gm%

3.Inflammatory or post-infectious knee arthritis

4.History of prior knee replacement or repair

5.Prior fracture of the knee joint

6.Any Knee injection within 3 months

7.Daily use of opioid medication

8.Coexisting backache, other chronic pain disorder

9.Body mass index (BMI) >=40 kg/m2

10.Blood disorders, hematological, cardiac, hepatic or renal disorders.

11.Persons who receive oral, topical or intra-articular steroid last four weeks, pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)Pain Score (0-100)Timepoint: Baseline visit (V0), 6 weeks(V1) and 12 weeks(V2)post intervention

Secondary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome Score (KOOS) (0-100)Timepoint: Baseline visit (V0), 6 weeks(V1) and 12 weeks(V2)post intervention;Quantifications of Serum (s-) Biomarkers (s-hsCRP, s-PIIANP, s-COMP, s-HA)Timepoint: Baseline visit (V0), 6 weeks(V1) and 12 weeks(V2)post intervention;Quantifications of Urinary (u-)Biomarkers( u-CTX, u-NTX)Timepoint: Baseline visit (V0), 6 weeks(V1) and 12 weeks(V2)post intervention;USG findings of the target Knee jointTimepoint: Baseline visit (V0), 6 weeks(V1) and 12 weeks(V2)post intervention