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

Primary Purpose

Osteoarthritis

Status
Withdrawn
Phase
Phase 4
Locations
Bahrain
Study Type
Interventional
Intervention
Intra-articular platelet-rich plasma
Intra-articular corticosteroid injections
Sponsored by
King Hamad University Hospital, Bahrain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Knee, Osteoarthritis, Bahrain, PRP, Steroid, WOMAC, Oxford Knee Score, Platelet-rich plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Orthopedic Clinic King Hamad University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intra-articular corticosteroid

Intra-articular platelet-rich plasma

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Improvement in WOMAC Knee Score
WOMAC - Western Ontario and Mcmaster index of Osteoarthritis

Secondary Outcome Measures

Improvement in SF12 score
SF12- patient satisfaction survey ( short form 12 point survey)
Improvement in Oxford Knee Score
Oxford Knee Score

Full Information

First Posted
August 13, 2013
Last Updated
October 21, 2019
Sponsor
King Hamad University Hospital, Bahrain
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1. Study Identification

Unique Protocol Identification Number
NCT01923909
Brief Title
Intraarticular Platelet-rich Plasma Injections Versus Corticosteroid Injections in Primary Knee Osteoarthritis
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 Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Hamad University Hospital, Bahrain

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Knee, Osteoarthritis, Bahrain, PRP, Steroid, WOMAC, Oxford Knee Score, Platelet-rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra-articular corticosteroid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intra-articular platelet-rich plasma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intra-articular platelet-rich plasma
Other Intervention Name(s)
Prp
Intervention Description
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
Intervention Name(s)
Intra-articular corticosteroid injections
Other Intervention Name(s)
Depo Medrol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in WOMAC Knee Score
Description
WOMAC - Western Ontario and Mcmaster index of Osteoarthritis
Time Frame
6 weeks to 6 months
Secondary Outcome Measure Information:
Title
Improvement in SF12 score
Description
SF12- patient satisfaction survey ( short form 12 point survey)
Time Frame
6 weeks to 6 months
Title
Improvement in Oxford Knee Score
Description
Oxford Knee Score
Time Frame
6 weeks to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahsan J Butt, FRCS(T&O)
Organizational Affiliation
King Hamad University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tania Kumar, MBBCh
Organizational Affiliation
KHUH, RCSI-Bahrain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fathima M Nasmy, MBBCh
Organizational Affiliation
KHUH, RCSI-Bahrain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Khaleefa ElMusharraf, MBBS,FRSPH
Organizational Affiliation
Royal College of Surgeons, Ireland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fares Uddin, MBBCh
Organizational Affiliation
King Hamad University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Clinic King Hamad University Hospital
City
Muharraq
ZIP/Postal Code
228
Country
Bahrain

12. IPD Sharing Statement

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

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