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Knee Osteoarthritis study

An open label comparative study to evaluate safety and effectiveness of intraarticular injection of Autologous Growth Factor Concentrate (AGFC) versus Hyaluronic acid (HA) in Knee Osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033302
Enrollment
100
Registered
2021-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: M171- Unilateral primary osteoarthritisof knee

Interventions

Intervention1: Autologous Growth Factor Concentrate intra-articular injection: Autologous Growth Factor Concentrate intra-articular injection given in the affected knee joint at Baseline, Month 1 and

Sponsors

Wockhardt Regenerative Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Confirmed osteoarthritis of the knee joint on radiological assessment (Grade I, II & III on Kellgren-Lawrence Grading Scale) and 2. Visual Analogue Scale (VAS) pain score of 4 or more (on numeric rating scale) since past 2 weeks in spite of taking NSAIDs

Exclusion criteria

Exclusion criteria: 1. Grade IV on Kellgren-Lawrence Grading Scale 2. Past surgery or fracture on knee joint 3. Knee instability

Design outcomes

Secondary

MeasureTime frame
Change from baseline of VAS pain numeric rating scaleTimepoint: Baseline, Month 1, Month 2, Month 5, Month 8, and Month 11;Change from baseline of WOMAC scoreTimepoint: Baseline, Month 5 and Month 8—

Primary

MeasureTime frame
Change from baseline of Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC)Timepoint: Baseline and Month 11]—

Countries

India

Contacts

Public ContactDr Ashima Bhatia

Wockhardt ltd

abhatia@wockhardt.com02226534444

Outcome results

None listed

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