Intraarticular Platelet-rich Plasma Injections Versus Corticosteroid Injections in Primary Knee Osteoarthritis

Comparison of Intraarticular Platelet-rich Plasma Injections With Intraarticular Corticosteroid Injections in the Treatment of Primary Knee Osteoarthritis : A Randomized Control Trial

Aim: To study and compare the clinical effects of platelet-rich plasma (PRP) injections and intra-articular (IA) corticosteroid injections in patients with primary osteoarthritis (OA) of the knee. This study aims to demonstrate this by using the Oxford Knee Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC) to illustrate quantifiable difference between the two treatment modalities. Patient satisfaction will be compared by utilizing the Short-Form Survey-12 (SF-12) Score. Our null hypothesis states that intra-articular PRP injections is more beneficial in the long-term treatment of primary OA of the knee.

Study Overview

• Status: Withdrawn
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Intra-articular corticosteroid injections; Drug: Intra-articular platelet-rich plasma

Detailed Description

This is a single blinded, randomized clinical trial. Subjects will be male or female patients with Grade 1,2 or 3 OA of the knee classified based on the radiological Kellgren -Lawrence grading system.

100 patients will be recruited for this study and 50 patients each will be randomized to one of the treatment groups using block randomization i.e. receiving either treatment IA corticosteroids or IA PRP injections. The patients will be informed of and will be consented to the treatment they will be receiving. An investigator from the research team, blinded to group assignment, will assist patients in completing the Oxford Knee score, WOMAC and SF-12 scores prior to receiving the treatment and at 6 weeks, 3 months and 6 months after receiving the treatment. In addition, they will be followed by regularly (at 3 weeks, 9 weeks, 4 months and 5 months) via telephone to inquire about any side effects of the treatment and to document patient satisfaction. Subjects in both groups will continue to receive concomitant treatments both pharmacological and nonpharmacological. All subjects will receive physiotherapy sessions with their respective intervention. Subjects will continue to receive treatment even if they wish to withdraw from the study at any point.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bahrain
  • Muharraq, Bahrain, 228
    • Orthopedic Clinic King Hamad University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical and radiological diagnosis of Primary Osteoarthritis of Knee joint
• Grade 1, 2, or 3 as per Kellgren and Lawrence radiological grading system.
• Symptomatic at presentation as per Visual Analogue pain scale
• Above 18 years of age
• Consenting to participate

Exclusion Criteria:

• Deformities
• Malalignments
• Rheumatoid lesions
• Gouty lesions
• BMI more than 35
• Use of steroids in the recent 6 weeks
• Pregnant
• Breast feeding
• Active malignancy
• Active infections
• Hemoglobin less than 11
• Platelet less than 150,000/mm3 and
• Bleeding disorders/blood dyscrasias or hemoglobinopathies
• Any contraindications to treatments
• Uncontrolled diabetes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intra-articular corticosteroid; Intra-articular corticosteroid injections Patients receiving the IA corticosteroid will be injected 3mL of 0.5% Bupivacaine and 2mL of 80mg Depo Medrol in a 10cc syringe, using an aseptic technique into the suprapatellar pouch. After an IA corticosteroid injection, patients are always advised to rest for 24 hours, and weigh bear as little as possible for the following 3 days. The procedure will be performed by a senior resident with several years of experience or a consultant Orthopedic surgeon.	Drug: Intra-articular corticosteroid injections; Patients receiving the IA corticosteroid will be injected 3mL of 0.5% Bupivacaine and 2mL of 80mg Depo Medrol in a 10cc syringe, using an aseptic technique into the supra patellar pouch. After an IA corticosteroid injection, patients are always advised to rest for 24 hours, and weigh bear as little as possible for the following 3 days. The procedure will be performed by a senior resident with several years of experience or a consultant Orthopedic surgeon.; Other Names: Depo Medrol
Experimental: Intra-articular platelet-rich plasma; IA PRP procedure This involves withdrawal of 10-15cc of patient's blood, which is collected and centrifuged in Rotofix 32 A Centrifuge machine at 1500 cycles/minute for 5 minutes. 3-4cc of the PRP is obtained and injected into the suprapatellar pouch using an aseptic technique. The procedure will be performed by the principal investigator, a qualified consultant Orthopedic surgeon. Analgesia will be administered as needed.	Drug: Intra-articular platelet-rich plasma; Intra-articular platelet-rich plasma This involves withdrawal of 10-15cc of patient's blood, which is collected and centrifuged in Rotofix 32 A Centrifuge machine at 1500 cycles/minute for 5 minutes. 3-4cc of the PRP is obtained and injected into the supra patellar pouch using an aseptic technique. The procedure will be performed by the principal investigator, a qualified consultant Orthopedic surgeon. Analgesia will be administered as needed.; Other Names: Prp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in WOMAC Knee Score	WOMAC - Western Ontario and Mcmaster index of Osteoarthritis	6 weeks to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in SF12 score	SF12- patient satisfaction survey ( short form 12 point survey)	6 weeks to 6 months
Improvement in Oxford Knee Score	Oxford Knee Score	6 weeks to 6 months

Collaborators and Investigators

• Sponsor: King Hamad University Hospital, Bahrain
• Investigators: Principal Investigator: Ahsan J Butt, FRCS(T&O), King Hamad University Hospital; Principal Investigator: Tania Kumar, MBBCh, KHUH, RCSI-Bahrain; Principal Investigator: Fathima M Nasmy, MBBCh, KHUH, RCSI-Bahrain; Principal Investigator: Khaleefa ElMusharraf, MBBS,FRSPH, Royal College of Surgeons, Ireland; Principal Investigator: Fares Uddin, MBBCh, King Hamad University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 13, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (Estimate): August 16, 2013

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; WOMAC; Steroid; PRP; Bahrain; Oxford Knee Score; Platelet-rich plasma
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Anti-Inflammatory Agents; Methylprednisolone Acetate
• Other Study ID Numbers: ATF02092012