Comparison of IA Platelet Rich Plasma Injections With IA Steroid Injections in Treatment of Primary Knee Osteoarthritis (Articular)

This study is currently recruiting participants.
Verified August 2013 by King Hamad University Hospital, Bahrain
Sponsor:
Information provided by (Responsible Party):
King Hamad University Hospital, Bahrain
ClinicalTrials.gov Identifier:
NCT01923909
First received: August 13, 2013
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

Aim: To study and compare the clinical effects of Platelet rich plasma (PrP) injections and Intra-Articular steroid injections in a group of patients with primary OA of the knee. This study will aim to illustrate 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 IA PrP is more beneficial in the long-term treatment of primary OA of the knee.


Condition Intervention Phase
Osteoarthritis
Drug: Intra- articular platelet rich plasma
Drug: Intra-articular steroid injections
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Intra-articular Platelet Rich Plasma Injections With Intra-articular Steroid Injections in the Treatment of Primary Osteoarthritis of the Knee : A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by King Hamad University Hospital, Bahrain:

Primary Outcome Measures:
  • Improvement in WOMAC Knee Score [ Time Frame: 6 weeks to 6 months ] [ Designated as safety issue: No ]
    WOMAC - Western Ontario and Mcmaster index of Osteoarthritis

  • Improvement in Oxford Knee Score [ Time Frame: 6 weeks to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in SF12 score [ Time Frame: 6 weeks to 6 months ] [ Designated as safety issue: No ]
    SF12- patient satisfaction survey ( short form 12 point survey)


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intra-articular steroid injections
Intra-articular steroid injections Patients receiving the IA steroid 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 steroid injection, patients are always advised to rest for 24 hours, and weigh bear as little as possible for the following 3 days. The procedure maybe performed by senior residents with several years of experience or a consultant Orthopedic surgeon.
Drug: Intra-articular steroid injections
Patients receiving the IA steroid 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 steroid injection, patients are always advised to rest for 24 hours, and weigh bear as little as possible for the following 3 days. The procedure maybe performed by senior residents 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 Names:
  • Intra- articular platelet rich plasma
  • Prp

Detailed Description:

This is a single blinded, randomized clinical trial. Subjects will be male or female with Grade 1,2 or 3 OA of the knee classified based on the radiologic 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 steroids or IA Prp injections. The patients will be aware and will be consenting 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.

The duration of this single blinded, prospective randomized trial will therefore be 6 months. Subjects will continue to receive treatment even if they wish to withdraw from the study at any point.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01923909

Locations
Bahrain
Orthopedic Clinic King Hamad University Hospital Recruiting
Busaiteen, Muharraq, Bahrain, 228
Contact: Jaffar M Al Bareeq, DLO RCP RCS    00973-17444275    muhammed.rizwan@khuh.org.bh   
Principal Investigator: Ahsan J Butt, MBBS, FRCS Ed         
Sponsors and Collaborators
King Hamad University Hospital, Bahrain
Investigators
Principal Investigator: Ahsan J Butt, MBBS,FRCS(Trauma&Ortho) King Hamad University Hospital
Principal Investigator: Tania Kumar, MBBChBAONUI KHUH, RCSI-Bahrain
Principal Investigator: Fathima M Nasmy, MBBChBAONUI KHUH, RCSI-Bahrain
Principal Investigator: Khaleefa ElMusharraf, MBBS,FRSPH RCSI-Bahrain
  More Information

No publications provided

Responsible Party: King Hamad University Hospital, Bahrain
ClinicalTrials.gov Identifier: NCT01923909     History of Changes
Other Study ID Numbers: ATF02092012
Study First Received: August 13, 2013
Last Updated: August 29, 2013
Health Authority: Bahrain: Ethics Committee

Keywords provided by King Hamad University Hospital, Bahrain:
Knee
Osteoarthritis
Bahrain
Prp
Steroid
WOMAC
Oxford Knee Score

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014