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临床试验/CTRI/2024/10/075179
CTRI/2024/10/075179招募中不适用

A comparative study of clinico-functional outcomes of intraarticular Platelet Rich Plasma and Platelet Rich Fibrin in the management of early osteoarthritis of knee – prospective randomized control trial

Dr Ankit1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
126
试验地点
1
主要终点
To compare the clinico-functional outcome of intraarticular platelet rich plasma and platelet rich fibrin in the management of early osteoarthritis of knee at 24th week

研究概览

简要总结

SL.

PARTICUARS

COMMENTS

|1.

Name of the PG student

DR. ANKIT

|2.

Name of the Guide

DR. HARIPRASAD S.

|3.

Title of the Topic

A COMPARATIVE STUDY OF CLINICO-FUNCTIONAL OUTCOMES OF INTRAARTICULAR PLATELET RICH PLASMA AND PLATELET RICH FIBRIN IN THE MANAGEMENT OF EARLY OSTEOARTHRITIS OF KNEE – PROSPECTIVE RANDOMIZED CONTROL TRIAL

|4.

Need for the study

PRP exerts its therapeutic mechanism via growth factors stored in the α-granule of platelets. Platelet-rich plasma has been proven to decrease inflammation, produce high-quality synovial fluid, and reconstruction of degenerative cartilage but its efficacy is yet be proven in conditions like osteoarthritis for long term results.

PRF showed promising properties in connective tissue regeneration and it is now widely applied in chronic wound healing and degenerative conditions. Patient treated with PRF showed better pain control and more persistent pain relief in short and mid-term than those treated with platelet rich plasma.

At present many studies have been done to examine the effectiveness of PRP and PRF individually, but a comparative study with a long term follow-up is yet to be performed.

|5.

Objectives of the study

·       To assess the clinico-functional outcomes of intra-articular injection of PRP in early OA knee using Visual Analogue Scale (VAS) and Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) at pre-procedure, post-procedure, 2nd, 4th, 8th, 12th, 24th weeks respectively.

·       To assess the clinico-functional outcomes intra-articular injection of PRF in early OA knee using VAS and WOMAC Osteoarthritis Index at pre-procedure, post-procedure, 2nd, 4th, 8th, 12th, 24th weeks respectively.

·       To compare clinico-functional outcomes intra-articular injection of PRP vs PRF in early OA knee knee using VAS and WOMAC Osteoarthritis Index at pre-procedure, post-procedure, 2nd, 4th, 8th, 12th, 24th weeks respectively.

  |7.

Material and Methods

STUDY DESIGN:

 A prospective comparative randomized control trial.

 To avoid patient selection bias patients will be grouped into two groups.  Patients will be randomly selected as per the randomization list generated by www.randomizer.org .

  |8.

Method of collection data including sampling procedure

SOURCE OF DATA:

A comparative prospective study will be conducted at R.L Jalappa hospital and research center attached to Sri Devaraj Urs Medical college, affiliated to SDUAHER, from MAY 2024 to OCTOBER 2024. 126 patients with early Osteoarthritis of knee will be included in the study.

After full filling the inclusion criteria and exclusion criteria, informed and written consent will be obtained from all patients who agree to be a part of the study

Patients will be divided into 2 groups

•        Group A included 63 patients who were treated with intra-articular Platelet Rich Plasma injection

•        Group B included 63 patients who were treated with intra-articular Platelet rich fibrin injection.

 INCLUSION CRITERIA:

·       Patients of either gender, aged between 45 to 70 years

·       Patients with early OA knee and Kellgren and Lawrence Scale (K&L) stage I and II

·       Patient with persistent symptoms (pain, joint stiffness etc) irrespective of being treated with conservative treatment, including physical therapy, manipulation

·       Patients were not under any other treatments for Osteoarthritis in the last month besides occasional analgesics

EXCLUSION CRITERIA:

·       Patients with severe osteoarthritis (K&L stage III and IV)

·       Patients treated with long release corticosteroids infiltration over the last month

·       Patients on immune suppressor or chemotherapy treatments

·       Acute rheumatoid arthritis and rheumatoid immune diseases

·       Local/general infections; patients with previous joint replacement

·       Low platelets (<100.000) or low fibrinogen

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
45.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients with early OA knee and Kellgren and Lawrence Scale (K&L) stage I and II.
  • Patient with persistent symptoms (pain, joint stiffness etc) irrespective of being treated with conservative treatment, including physical therapy, manipulation.
  • Patients were not under any other treatments for Osteoarthritis in the last month besides occasional analgesics.

排除标准

  • Patients with severe osteoarthritis ( K& L stage III and IV) Patient treated with long release corticosteroids infiltration over the last month Patient on immune suppresor or chemotherapy treatment Local/ general infections; patient with previous joint replacement Actue rheumatoid arthritis and rheumatoid immune diseases Low platelets (100,000) or low fibrinogen.

结局指标

主要结局

To compare the clinico-functional outcome of intraarticular platelet rich plasma and platelet rich fibrin in the management of early osteoarthritis of knee at 24th week

时间窗: 24th week

次要结局

  • To compare the clinico-functional outcome of intraarticular platelet rich plasma & platelet rich fibrin in the management of early osteoarthritis of knee at 2nd week, 4th week, 8th week, 12th week,24th week(2nd week, 4th week, 8th week, 12th week, 24th week)

研究者

发起方
Dr Ankit
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ankit

Sri Devaraj Urs Academy of Higher Education and Research

研究点 (1)

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