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A Study to evaluate effect of oral bisphosphonate with Platelets rich plasma in knee Osteoarthritis

A randomized controlled Study for clinical evaluation of synergistic effect of oral bisphosphonate with Platelets rich plasma in knee Osteoarthritis - ALNPRP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049883
Enrollment
284
Registered
2023-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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: Platelets Rich Plasma with Alendronate: 3 doses of freshly prepared autologous 4 ml Leucocytes Poor Platelets Rich Plasma given for each knee at monthly interval with weekly 70mg of Al

Sponsors

Amit Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Early stage of Degenerative osteoarthritis of knee 1.History of pain for the last 3 months according to the ACR criteria for knee osteoarthritis along with radiologic evidence of joint changes based on Kellgren-Lawrence criteria (including grades 1,2 and 3). 2.Mild radiographic OA of the medial compartment (medial tibiofemoral joint space 3.Mild varus malalignment by clinical examination

Exclusion criteria

Exclusion criteria: 1. Age 75 years 2. Any form of knee injection such as visco-supplements, ozone etc. in the preceding 3 months; 3. Having arthroscopic or open surgery in the past 6 months; 4. Having metabolic bone disease immunodeficiency, autoimmune disease, collagen vascular disease, or diabetes; 5. History of cancer; 6. Infection or inflamed lesion in the knee; 7. Platelet disorder or disease; 8. Use of anticoagulant or anti-platelet medication 10 days before injection; 9. Use of NSAIDs 2 days before injection; 10. Corticosteroid knee injection 3 weeks before injection or use of systemic corticosteroids 2 weeks before the injection; 11. Hemoglobin level less than 10 g/dL and platelets less than 150,000/microliter; 12. History of severe knee trauma; 13. Pregnancy and lactation; 14. Hypersensitivity to Bisphoshphonate 15. History of Renal impairment 16. Non-reactive for HIV, HBsAg and HCV by chemiluminscence 17. In diabetic patients Fasting blood sugar less than 110mg/dl and HbA1c less than 7.5 %

Design outcomes

Primary

MeasureTime frame
Improvement of pain using Visual Analogue Scale, Improvement in Knee functional status by calculating Western Ontario and McMaster universities Osteoarthritis Index (WOMAC) Scores Timepoint: 6 and 12 months after completion of 3 months treatment

Secondary

MeasureTime frame
Conversion to Surgical OptionTimepoint: 2 years after completion of 3 months treatment

Countries

India

Contacts

Public ContactAmit Kumar

Sanjay Gandhi Postgraduate Institute Of Medical Sciences

amit2k03@gmail.com9839020847

Outcome results

None listed

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