Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607608327898 Date of Registration: 24/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound-Guided intra-Articular injection of Autologous Bone Marrow Aspirate Concentrate versus Platelet-Rich Plasma or Hyaluronic Acid for Management of Chronic Knee Pain
Official scientific title Ultrasound-Guided intra-Articular injection of Autologous Bone Marrow Aspirate Concentrate versus Platelet Rich Plasma or Hyaluronic Acid Combined with Genicular Nerve Block for Management of Chronic Knee Osteoarthritis Pain: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: Knee osteoarthritis (OA) is a prevalent cause of pain and disability. Conventional treatments often provide limited and transient relief. Ortho-biologic therapies, including bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP), have emerged as potential alternatives. Objectives: To compare the efficacy and safety of ultrasound-guided intra-articular injections of autologous BMAC, PRP, and hyaluronic acid (HA) combined with genicular nerve block in patients with chronic knee OA pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Chronic Knee osteoarthritis pain,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/09/2023
Actual trial start date 02/10/2023
Anticipated date of last follow up 24/05/2026
Actual Last follow-up date 25/05/2026
Anticipated target sample size (number of participants) 187
Actual target sample size (number of participants) 165
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intraarticular Hyaluronic Acid injection in knee joint combined with genicular nerve block Single intra-articular knee injection The effect of the injection was measured for 12 months Patients received intra-articular knee injection of high-molecular-weight HA (20 mg/2 mL) under real ultrasound guidance in the suprapatellar pouch 55 Active-Treatment of Control Group
Experimental Group Intraarticular Bone Marrow Aspirate concentrate knee injection combined with genicular nerve block Single intra-articular knee injection The effect of the injection was measured for 12 months Bone marrow was aspirated from the posterior iliac crest under sterile conditions. Approximately 60 mL of bone marrow was collected and processed using a closed centrifugation system to yield 6–8 mL of BMAC. The aspirate contained mesenchymal stem cells, hematopoietic progenitors, and platelets. The injection was performed under real-time ultrasound guidance in the suprapatellar pouch of the knee joint 55
Experimental Group Intraarticular Platelet Rich plasma injection in knee joint combined with genicular nerve block Single intra-articular knee injection The effect of the injection was measured for 12 months Peripheral blood (30 mL) was drawn and centrifuged to obtain 4–5 mL of leukocyte-poor PRP with platelet concentration standardized to 4–5 times baseline. The PRP was injected intra-articular under ultrasound guidance in the suprapatellar pouch of the knee joint 55
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Chronic knee pain (>6 months) Failure of conservative management Willingness to comply with follow-up Inflammatory arthritis Prior knee surgery within 12 months Systemic infection Coagulopathy Malignancy Pregnancy Any intra-articular injection within 3 months prior to enrollment Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/09/2023 Ethics Committee Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion street, El Messalah, Alexandria, Egypt Alexandria 21526 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain assessed by Visual Analog Scale (VAS) Baseline, 1, 3, 6, and 12 months
Secondary Outcome Functional improvement measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score (KOOS) at the same intervals. Radiographic assessment using calibrated X-rays Patient satisfaction and adverse events Baseline, 1, 3, 6, and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Smouha University Hospital Ismail Sari street Alexandria 21648 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Nassar 14th of May road, Smouha Alexandria 21648 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Nassar 14th of May road, Smouha Alexandria 21648 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Nassar m_nassar00@alexmed.edu.eg +201002413831 14th of May road, Smouha
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Lecturer of Anaesthesia and Surgical intensive care Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Public Enquiries Mohamed Nassar m_nassar00@alexmed.edu.eg +201002413831 14th of May road, Smouha
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Lecturer of Anaesthesia and Surgical intensive care Faculty of Medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Mohmed Nassar m_nassar00@alexmed.edu.eg +201002413831 14th of May road, Smouha
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Lecturer of Anaesthesia and Surgical intensive care Faculty of Medicine Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual deidentified participant data (including data dictionaries) will be shared including study protocol, statistical analysis plan. Data will become available 3 months after publication and will remain available; no end date. Researchers who provide a methodologically sound proposal will have access to data to achieve aim in the approved proposal. Proposals should be directed to m_nassar00@alexmed.edu.eg to gain access; data requesters will need to sign access agreement. Data will be available in the 3rd party website (link will be provided). Statistical Analysis Plan,Study Protocol Beginning 3 months after publication. No end date Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 19/07/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/07/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 19/06/2026 Although 165 patients were enrolled, 8 patients were lost for follow up, so the final analyzed sample size dropped to 157. 157 165
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 19/06/2026 I updated the age range to include 18-44 years to ensure it includes the required minimum age of 40, aligning with the inclusion criteria Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s) Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 19/06/2026 The authentic Ethics Committee approval letter has now been uploaded. The document includes the official approval number, approval date, committee signature, and institutional stamp. TRUE, Ethics Committee Faculty of Medicine Alexandria University, 17 Champollion street, El Messalah, Alexandria, Egypt, Alexandria, 21526, Egypt, , 10 Sep 2023, +201228700903, ethics.comm@alexmed.edu.eg, 41486_38789_4737.pdf TRUE, Ethics Committee Faculty of Medicine Alexandria University, 17 Champollion street, El Messalah, Alexandria, Egypt, Alexandria, 21526, Egypt, , 10 Sep 2023, +201228700903, ethics.comm@alexmed.edu.eg, 41486_38789_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 19/06/2026 The Source Name was updated from 'Self Funded' to the actual name of the Principal Investigator, in accordance with the reviewer’s request. The funding source remains self-funded. Self Fuded, 14th of May road, Smouha, Alexandria, 21648, Egypt, Self Funded, Mohamed Nassar, 14th of May road, Smouha, Alexandria, 21648, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 19/07/2026 Submission of the Summary Results Overview in accordance with PACTR reporting requirements No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 19/07/2026 Initial submission of study summary results 41486_28651_1045.pdf