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

Not Applicable

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

Registration Number: CTRI/2023/02/049883

Lead Sponsor: Amit Kumar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 <= 2 mm on a weightbearing fixed flexion PA view/Rosenberg view);

3.Mild varus malalignment by clinical examination

Exclusion Criteria

1.Age <50 years and >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 %

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of pain using Visual Analogue Scale, <br/ ><br>Improvement in Knee functional status by calculating Western Ontario and McMaster universities Osteoarthritis Index (WOMAC) Scores <br/ ><br>Timepoint: 6 and 12 months after completion of 3 months treatment

Secondary Outcome Measures