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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01923909
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : August 16, 2013
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
King Hamad University Hospital, Bahrain

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Prp




Primary Outcome Measures :
  1. Improvement in WOMAC Knee Score [ Time Frame: 6 weeks to 6 months ]
    WOMAC - Western Ontario and Mcmaster index of Osteoarthritis


Secondary Outcome Measures :
  1. Improvement in SF12 score [ Time Frame: 6 weeks to 6 months ]
    SF12- patient satisfaction survey ( short form 12 point survey)

  2. Improvement in Oxford Knee Score [ Time Frame: 6 weeks to 6 months ]
    Oxford Knee Score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923909


Locations
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Bahrain
Orthopedic Clinic King Hamad University Hospital
Muharraq, Bahrain, 228
Sponsors and Collaborators
King Hamad University Hospital, Bahrain
Investigators
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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
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Responsible Party: King Hamad University Hospital, Bahrain
ClinicalTrials.gov Identifier: NCT01923909    
Other Study ID Numbers: ATF02092012
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Keywords provided by King Hamad University Hospital, Bahrain:
Knee
Osteoarthritis
Bahrain
PRP
Steroid
WOMAC
Oxford Knee Score
Platelet-rich plasma
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone Acetate
Anti-Inflammatory Agents