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

NCT ID: NCT01923909

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2019-12-31

Brief Summary

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.

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Intra-articular corticosteroid injections

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Intra-articular platelet-rich plasma

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Prp; Depo Medrol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Hamad University Hospital, Bahrain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahsan J Butt, FRCS(T&O)

Role: PRINCIPAL_INVESTIGATOR

King Hamad University Hospital

Tania Kumar, MBBCh

Role: PRINCIPAL_INVESTIGATOR

KHUH, RCSI-Bahrain

Fathima M Nasmy, MBBCh

Role: PRINCIPAL_INVESTIGATOR

KHUH, RCSI-Bahrain

Khaleefa ElMusharraf, MBBS,FRSPH

Role: PRINCIPAL_INVESTIGATOR

Royal College of Surgeons, Ireland

Fares Uddin, MBBCh

Role: PRINCIPAL_INVESTIGATOR

King Hamad University Hospital

Locations

Orthopedic Clinic King Hamad University Hospital

Al Muharraq, , Bahrain

Countries

Bahrain

Other Identifiers

ATF02092012

Identifier Type: -

Identifier Source: org_study_id