OsteoarthritisPhase 4NCT01923909
Intraarticular Platelet-rich Plasma Injections Versus Corticosteroid Injections in Primary Knee Osteoarthritis
A Phase 4 study testing Intra-articular platelet-rich plasma and Intra-articular corticosteroid injections in people with Osteoarthritis, run by King Hamad University Hospital, Bahrain at 1 site in Bahrain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Intra-articular platelet-rich plasma and Intra-articular corticosteroid injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBahrain
- Study dates
- Apr 2013to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Deformities
- Malalignments
- Rheumatoid lesions
- Gouty lesions
- BMI more than 35
- Use of steroids in the recent 6 weeks
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Bahrain1 site
Orthopedic Clinic King Hamad University Hospital
Al Muharraq, 228
About this study
Official title: Comparison of Intraarticular Platelet-rich Plasma Injections With Intraarticular Corticosteroid Injections in the Treatment of Primary Knee Osteoarthritis : A Randomized Control Trial
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Intra-articular platelet-rich plasma, Intra-articular corticosteroid injections
- Keywords
- Knee, Osteoarthritis, Bahrain, PRP, Steroid, WOMAC, Oxford Knee Score, Platelet-rich plasma
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular platelet-rich plasmaDrug
Also called Prp
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.
Intra-articular corticosteroid injectionsDrug
Also called Depo Medrol
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Intra-articular platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in WOMAC Knee Score
WOMAC - Western Ontario and Mcmaster index of Osteoarthritis
Measured: 6 weeks to 6 months
Secondary outcomes (2)
Improvement in SF12 score
SF12- patient satisfaction survey ( short form 12 point survey)
Measured: 6 weeks to 6 months
Improvement in Oxford Knee Score
Oxford Knee Score
Measured: 6 weeks to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Hamad University Hospital, Bahrain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahsan J Butt, FRCS(T&O), Principal investigator, King Hamad University HospitalTania Kumar, MBBCh, Principal investigator, KHUH, RCSI-BahrainFathima M Nasmy, MBBCh, Principal investigator, KHUH, RCSI-BahrainKhaleefa ElMusharraf, MBBS,FRSPH, Principal investigator, Royal College of Surgeons, IrelandFares Uddin, MBBCh, Principal investigator, King Hamad University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923909
- Sponsor's protocol ID
- ATF02092012
- Status last verified
- Oct 2019
- First submitted
- 13 Aug 2013
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraarticular Platelet-rich Plasma Injections With Intraarticular Corticosteroid Injections in the Treatment of Primary Knee Osteoarthritis : A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01923909
- Acronym / sponsor ID
- ATF02092012
- Conditions
- Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Bahrain, PRP, Steroid, WOMAC, Oxford Knee Score, Platelet-rich plasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- King Hamad University Hospital, BahrainUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular corticosteroid | Active comparator | Drug: Intra-articular corticosteroid injectionsIntra-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. |
| Intra-articular platelet-rich plasma | Experimental | Drug: Intra-articular platelet-rich plasmaIA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- Deformities
- Malalignments
- Rheumatoid lesions
- Gouty lesions
- BMI more than 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular platelet-rich plasmaAlso: PrpIntra-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. | Drug | Intra-articular platelet-rich plasma |
| Intra-articular corticosteroid injectionsAlso: Depo MedrolPatients 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. | Drug | Intra-articular corticosteroid |
Primary outcome
Improvement in WOMAC Knee Score
Time frame: 6 weeks to 6 months
WOMAC - Western Ontario and Mcmaster index of Osteoarthritis
2 secondary outcomes
Improvement in SF12 score
Time frame: 6 weeks to 6 months
Improvement in Oxford Knee Score
Time frame: 6 weeks to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahsan J Butt, FRCS(T&O) principal investigator
King Hamad University Hospital
Tania Kumar, MBBCh principal investigator
KHUH, RCSI-Bahrain
Fathima M Nasmy, MBBCh principal investigator
KHUH, RCSI-Bahrain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intra-articular platelet-rich plasma and Intra-articular corticosteroid injections in people with Osteoarthritis, run by King Hamad University Hospital, Bahrain at 1 site in Bahrain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bahrain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in WOMAC Knee Score (time frame: 6 weeks to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.