Intra-articular Injection of Allogenic Lyophilized Growth Factors in Primary Knee Osteoarthritis

Study Overview
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Brief Summary
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the study was conducted on 31-patients with symptomatic primary knee osteoarthritis. The patients were randomized into intervention and control groups. The control group was kept on their medications without intervention. The intervention group received two doses of allogenic lyophilized growth factors (L-GFs); at baseline and after 2 months.

Detailed Description
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the study included 31 patients with symptomatic primary knee osteoarthritis (KOA) The study group was randomized into an intervention group and a control one. The control group patients were kept on their traditional medications without any intervention, while intervention group patients were instructed to stop using non-steroidal anti-inflammatory drugs (NSAID) at least 1 week before the assessment and throughout the study. All participants were subjected to baseline clinical, radiographic, and ultrasonography assessment. Follow up assessments was conducted after 6 months. Patients of the intervention group received two doses of intra-articular knee injections of allogenic lyophilized growth factors (L-GFs); one dose at the baseline and the other was after 2 months. Lyophilized GFs were prepared at the Cairo Medical Centre Blood Bank from allogenic platelet rich plasma to according a previously published patented method. Prior to usage, reconstitution of the product was done using 1-ml saline and 1-ml lignocaine followed by gentle vial rubbing for 3 minutes. Then, the mixture was kept at ambient temperature for 5 minutes to ensure complete protein re-hydration. The injection was done under complete guidance of ultrasonography through lateral supra-patellar short axis in-plane approach under sterile aseptic conditions. After injection, local ice application and oral paracetamol were allowed if the patient felt pain. NSAIDs were completely avoided as they may inhibit the desired post-injection inflammatory process. Patients were encouraged to restrict vigorous knee activities for 48 hours.

Official Title
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Clinical and Ultrasonographic Assessment of Effectiveness of Intra-articular Knee Injection Using Platelet Derived Lyophilized Growth Factors in Egyptian Patients With Symptomatic Primary Knee Osteoarthritis

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Drug: allogenic lyophilized growth factors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Clinical and radiographic diagnosis of primary knee osteoarthritis Patients must be symptomatic Exclusion Criteria: Patients with secondary knee osteoarthritis previous intra-articular steroid, or hyaluronic knee injection in last year Patients with other disabling lower limb osteoarthropathy or myopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allogenic lyophilized growth factors<br>Two doses of intra-articular knee injections of lyophilized growth factors were received one dose at the baseline and the other was after 2 months. | Drug: allogenic lyophilized growth factors<br>* Prior to usage, reconstitution of the product was done using 1-ml saline and 1-ml lignocaine followed by gentle vial rubbing for 3 minutes. Then, the mixture was kept at ambient temperature for 5 minutes to ensure complete protein re-hydration.<br>|
| No Intervention: Standard of care<br>The patients were kept on their traditional medications without any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline WOMAC scores at 6 months | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores consist of 24 questions in 3 sections regarding; five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A sum of the scores for all three sub-scales gives a total WOMAC score. The higher scores mean a worse outcome. | At baseline and after 6 months. | 
| Change from Baseline structural outcomes scores at 6 months | Knee ultrasonography assessment of effusion, femoral cartilage, anterior horn medial meniscus, synovial hypertrophy | At baseline and after 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post injection complications of the intervention treatment | The patients of the intervention group were asked if they experienced any adverse events following the injection, with special concern on: Post-injection pain: Both the duration and intensity were documented. The pain intensity was measured by 0-10 visual analogue scale (VAS). General symptoms or signs related to infection and allergy such as fever, chills, pruritus, dyspnea, urticaria, or rash. Erythema, swelling, or abnormal discharge from the site of injection. | at each time following the injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, allogenic platelet rich plasma, lyophilization, growth factors