Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Leon Jonker
+44 (0)1228 608926
leon.jonker@nihr.ac.uk


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Hyaluronate [Viscoseal] injection after knee surgery; an evaluation
Back

Hyaluronate [Viscoseal] injection after knee surgery; an evaluation

Recruiting

Open to: All Genders

Age: Adult

Carlisle

Medical Conditions

Elective orthopaedic surgery

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Arthroscopic, or keyhole, surgery on the meniscus in the knee joint has benefits over open surgery. Nonetheless, there is scope to further improve outcomes for patients by reducing pain and discomfort and promoting enhanced recovery of knee joint functionality. The medical device Viscoseal contains hyaluronan and is designed to replenish levels of this compound in the knee joint following arthroscopic repair of the meniscus. Natrually, synovial fluid in the knee joint contains hyaluronan, but a lot of it is washed away when surgeons flush the knee joint during surgery to remove loose pieces of meniscus, cartilage, or bone. Previous studies, both in laboratory studies and patient trials, have demonstrated that Viscoseal can promote re-establishment of biological structure in the knee joint to allow it to return to a normal physiological state and protect cartilage.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jan 2020 31 Dec 2024

This present prospective, randomised, controlled trial aims to build on this evidence by comparing standard care versus the injection of Viscoseal (26 vs 26 patients) at the end of arthroscopic meniscus repair surgery. The degree of pain, leg swelling and knee functionality experienced by patients after surgery will be measured using validated patient surveys focused on the meniscus. In addition, a detailed picture of what happens to the meniscus after surgery +/- administration of Viscoseal will be obtained through MRI radiologic imaging. The main objective is to determine if Viscoseal can achieve a minimal clinically important difference in pain relief after meniscal repair surgery when compared to standard care.


Patients aged 18 – 59 years due to undergo meniscal surgery of the knee for meniscal tear grade III (including repair, partial meniscectomy or complete meniscectomy).

You can take part if:



You may not be able to take part if:


1. BMI > 35 2. Known hypersensitivity to hyaluronic acid, other constituents of Viscoseal, marcaine, codydramol 3. Any auto-immune disease that affects the limbs, such as rheumatoid arthritis, treated with immune-modulating drugs4. Inflammatory arthropathy5. Co-existing condition that significantly impacts on usual daily activities (including, but not limited to, lower limb amputation, cancer, neurodegenerative disease, or other condition that leaves patient invalid or to use a wheelchair) as assessed by recruiting clinician6. Any other reason that would mean that compliance with the trial scheme would be challenging or impractical (eg extended travel abroad)7. Contraindications for MRI diagnostics (see https://radiology.ucsf.edu/patient-care/patient-safety/mri/absolute-contraindications) since qualifying meniscal injury pre-surgery needs to be demonstrated by MRI


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Carleton Clinic
    Cumbria Partnership NHS Foundation Trust Cumwhinton Road
    Carlisle
    CA1 3SX

Benefits: For participants in the control group there is no direct benefit for taking part in this study. You will be cared for in exactly the same manner as you normally would, bar the introduction of a few questionnaires and a potential extra MRI scan. However, by taking part you will contribute to comparison of the effectiveness of adding hyaluronate to a meniscus operation, to optimise management of meniscus surgery in the future. For participants in the Viscoseal® intervention group there may be benefits in terms of reduced pain and swelling after the procedure. However, this has not yet been proven and established beyond doubt, and this study is aimed to assess this further.
Risks: There is no significant personal safety risk anticipated regarding taking part in this study. Like with any invasive procedure, the meniscus surgery carries (post-operative) risks such as bleeding, blood clots and infection. However, the arhroscopic surgery itself is not classed as being part of this HIKE study; the injection of Viscoseal® at the end of the procedure is. Fifty percent of patients do not receive this and therefore for them there is no additional risk over and above that related to standard care.

Dr Leon Jonker
+44 (0)1228 608926
leon.jonker@nihr.ac.uk



The study is sponsored by North Cumbria University Hospitals NHS Trust and funded by TRB Chemedica (UK) Ltd.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN10972486

Or CPMS 43835

Last updated 22 November 2023

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top