Clinical trial NCT01923909: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Knee
Osteoarthritis
Bahrain
PRP
Steroid
WOMAC
Oxford Knee Score
Platelet-rich plasma
Lead sponsor: King Hamad University Hospital, Bahrain
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improvement in WOMAC Knee Score
timeFrame: 6 weeks to 6 months
Secondary outcomes:
measure: Improvement in SF12 score
timeFrame: 6 weeks to 6 months
measure: Improvement in Oxford Knee Score
timeFrame: 6 weeks to 6 months
Other outcomes:
Locations:
city: Muharraq
country: Bahrain
facility: Orthopedic Clinic King Hamad University Hospital
Study officials:
affiliation: King Hamad University Hospital
name: Ahsan J Butt, FRCS(T&O)
role: PRINCIPAL_INVESTIGATOR
affiliation: KHUH, RCSI-Bahrain
name: Tania Kumar, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: KHUH, RCSI-Bahrain
name: Fathima M Nasmy, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal College of Surgeons, Ireland
name: Khaleefa ElMusharraf, MBBS,FRSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: King Hamad University Hospital
name: Fares Uddin, MBBCh
role: PRINCIPAL_INVESTIGATOR
References: