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

Sponsor

King Hamad University Hospital, Bahrain (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01923909

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Intra-articular platelet-rich plasma Drug: Intra-articular corticosteroid injections	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Improvement in WOMAC Knee Score [6 weeks to 6 months]
WOMAC - Western Ontario and Mcmaster index of Osteoarthritis

Secondary Outcome Measures

Improvement in SF12 score [6 weeks to 6 months]
SF12- patient satisfaction survey ( short form 12 point survey)
Improvement in Oxford Knee Score [6 weeks to 6 months]
Oxford Knee Score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orthopedic Clinic King Hamad University Hospital	Muharraq		Bahrain	228

Sponsors and Collaborators

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