A Phase 4 interventional study of platelet rich plasma in Knee Pain and Knee Injuries, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-11.
Sponsored by Alexandria University · Phase 4, Interventional, and Supportive care
The investigator's hypothesis was that intra-articular knee injection with PRP in patients underwent arthroscopic meniscal repair and didn't receive intra-surgical PRP, may add beneficial effect on post-meniscal repair outcomes regarding pain, functional state of the operated knee as well as healing process.
The study was done on 30 patients underwent arthroscopic isolated meniscal repairs performed by a single surgeon but unfortunately didn't receive PRP injection during the repair procedure.
Random, double blinded selection of 15 patients to constitute the PRP-group was injected intra-articularly with about 5 ml of PRP in the operated knee joint. The other fifteen patients were not injected and constituted control group. PRP preparation:
Thirty ml of venous blood was taken from every patient and collected in sodium citrated sterile tubes. Platelet concentrates obtained by adjusting centrifuge at 1800 rpm for 15 min to separate erythrocytes, then at 3500 rpm for 10 min to concentrate the platelets. The preparation was done by a single laboratory technician. Thus 5 ml of PRP were obtained, 0.2 mL of 10% calcium chloride was added to the final product to activate the platelets and injected immediately without storage. Procedure Pre-injection guidelines were given to all patients (in PRP group) in the form of stopping steroidal and non-steroidal anti-inflammatory drugs for at least one week before the procedure, as well as stopping any anticoagulant drugs 5 days before the procedure, increasing intake of fluids within the 24 hours prior to the procedure and anti-anxiety medication were required for anxious patients. Injection, under complete aseptic techniques, was performed while the patient was in supine position, and the knee was fully extended, using the lateral approach. Patients were instructed after injection to avoid using the injected leg for 24 hours, to use ice packs over the injected joint and not to use NSAIDs for another one week.
249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 160 interventional studies indexed under Knee Injuries.
Browse Knee Injuries studies →Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
15 patients to constitute the PRP-group was injected intra-articularly with about 5 ml of PRP in the operated knee joint
Biological: platelet rich plasma
The other fifteen patients were not injected and constituted control group.
Thirty ml of venous blood was taken from every patient and collected in sodium citrated sterile tubes. Platelet concentrates obtained by adjusting centrifuge at 1800 rpm for 15 min to separate erythrocytes, then at 3500 rpm for 10 min to concentrate the platelets. The preparation was done by a single laboratory technician. Thus 5 ml of PRP were obtained, 0.2 mL of 10% calcium chloride was added to the final product to activate the platelets and injected immediately without storage.
knee Pain
visual analogue scale, a line 10cm long, zero represent no pain and 10 represent maximal pain, the patient is asked to put a mark that describe his pain
Time frame: 3 months
Knee function
Knee injury and osteoarthritis outcome score, assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems
Time frame: 3 months
meniscal healing process
by ultrasonography
Time frame: 3 months
knee pain
visual analogue scale, a line 10cm long, zero represent no pain and 10 represent maximal pain, the patient is asked to put a mark that describe his pain
Time frame: 6 months
knee function
Knee injury and osteoarthritis outcome score, assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems
Time frame: 6 months
meniscal healing
by ultrasonography
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Alexandria University