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

Cartilage turnover and changes in inflammatory biomarkers and its correlation with clinical efficacy after intra-articular and intra-osseous Platelet Rich Plasma Injections in Osteoarthritis: Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021708
Enrollment
96
Registered
2019-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee

Interventions

Intervention1: Group I (intra-osseous, intra-articular PRP Group): Under aseptic conditions, total 18 ml of PRP (8ml of intra-articular and 10 ml intra-osseous) will be infiltrated into the target kne

Sponsors

Indian Council Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

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

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 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactApurba Barman

AIIMS Bhubaneswar

apurvaa23@gmail.com09438884211

Outcome results

None listed

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