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Completed

NCT Number: NCT04331327

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

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.

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Key information

Conditions

Osteo Arthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

rheumatology and clinical immunology unit of internal medicine department of Kasr Al-ainy Hospital, Cairo University

Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

allogenic lyophilized growth factors

Drug

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.

Primary outcomes

  1. Change from Baseline WOMAC scores at 6 months

    Time frame: At baseline and after 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.

  2. Change from Baseline structural outcomes scores at 6 months

    Time frame: At baseline and after 6 months.

    Knee ultrasonography assessment of effusion, femoral cartilage, anterior horn medial meniscus, synovial hypertrophy

Secondary outcomes

  1. post injection complications of the intervention treatment

    Time frame: at each time following the injection

    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.

Sponsors and collaborators

Lead sponsor

Rasmia Elgohary

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 2, 2020
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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