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

Osteo Arthritis Knee Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331327
• Other study ID #: 1/2016-2017
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2017
• Est. completion date: April 28, 2018

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 28, 2018
• Est. primary completion date: April 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• allogenic lyophilized growth factors
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.

Locations

Country	Name	City	State
Egypt	rheumatology and clinical immunology unit of internal medicine department of Kasr Al-ainy Hospital, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Rasmia Elgohary

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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

External Links

•   A patent method describing the preparation of lyophilized growth factors from allogenic platelet rich plasma