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

NCT01923909 | Withdrawn Phase 4 DMC

• 1 other identifier: ATF02092012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Knee; Osteoarthritis; Bahrain; PRP; Steroid; WOMAC; Oxford Knee Score; Platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• Improvement in WOMAC Knee Score

  WOMAC - Western Ontario and Mcmaster index of Osteoarthritis

  6 weeks to 6 months

Secondary Outcomes (2)

• Improvement in SF12 score

  6 weeks to 6 months

• Improvement in Oxford Knee Score

  6 weeks to 6 months

Study Arms (2)

Intra-articular corticosteroid

ACTIVE COMPARATOR

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

Intra-articular platelet-rich plasma

EXPERIMENTAL

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

Interventions

Intra-articular platelet-rich plasma 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.

Also known as: Prp

Intra-articular platelet-rich plasma

Intra-articular corticosteroid injections 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.

Also known as: Depo Medrol

Intra-articular corticosteroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Hamad University Hospital, Bahrain: lead

Study Sites (1)

Orthopedic Clinic King Hamad University Hospital

Al Muharraq, 228, Bahrain

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Pituitary Adenylate Cyclase-Activating Polypeptide; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Neuropeptides; Proteins; Nerve Tissue Proteins; Biological Factors; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 16, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

BA (1)