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A Study to Evaluate the Safety and Effectiveness of Platelet Rich Plasma Therapy.

A prospective, observational, single arm, multicenter, openlabel, postmarket clinical followup study to evaluate the safety and performance of Placera Platelet Rich Plasma (PRP) Kit in a realworld setting. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/07/113478
Enrollment
104
Registered
2026-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: M255- Pain in joint

Interventions

Intervention1: Nil: Nil

Sponsors

Meril Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Participant of age 18 and above, irrespective of gender presenting with orthopedic conditions such as osteoarthritis, tendon injuries, cartilage defects, fractures, spinal fusion requirements, sports-related injuries, chronic wound or soft tissue healing 2 Participants considered failure of conservative treatment measures oral medications, physical therapy, and/or injection therapy 3 Participants who are able, and willing to provide voluntary, written informed consent to participate in this study 4 Participants showing Kellgren-Lawrence classification Grade 0-3

Exclusion criteria

Exclusion criteria: 1 Participants who are unwilling or unable to sign the Informed Consent Document 2 Participants who have following conditions Platelet Dysfunction Syndrome, Critical Thrombocytopaenia, Hypofibrinogenaemia, Hemodynamic Instability, Auto-Immune Diseases, Malignancy, Sepsis, Acute Chronic Infection, Chronic Liver Pathology, Anti coagulation Therapy ASA Therapy, Newborns 3 Pregnant or breast-feeding women 4 Participants showing Kellgren-Lawrence classification Grade 4 5 Participants who are using NSAIDs for chronic pain management 6 Participants undergoing physiotherapy prior to enrollment

Design outcomes

Primary

MeasureTime frame
1 To Assess the Pain Severity Using Visual Analog Scale and Adverse events and Improvement in Range of Motion and Improvement in Knee Society Scores Timepoint: baseline, Intra-operative, Through Discharge, 2 weeks, 30 days, 3 months, 6 months

Secondary

MeasureTime frame
1 Post-treatment Participant s Satisfaction 2 International Knee Documentation Committee Score 3 Reduced Use of Analgesics 4 The 6-Minute Pain-Free Walking Distance 5 Kellgren Lawrence Classification 6 Hematological Assessment 7 Procedure Time 8 Platelets, Activation, White cells System Classification 9 DEPA Classification 10 SF-36 Questionnaire Quality of lifeTimepoint: 1 2 weeks, 30 days, 3 months, 6 months 2 Baseline, 30 days 3 2 weeks, 30 days, 3 months, 6 months 4 Baseline, 2 weeks, 30 days, 3 months, 6 months 5 Baseline, 2 weeks, 30 days, 3 months, 6 months 6 Baseline, 2 weeks, 30 days, 3 months, 6 months 7 Intraoperative 8 Intraoperative 9 Intraoperative 10 Baseline, 2 weeks, 30 days, 3 months, 6 months

Countries

India

Contacts

Public ContactDr Kirankumar Shetty

Meril Life Sciences Pvt Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026