HIKE trial
Research type
Research Study
Full title
A single-centre, randomised, placebo-controlled single-blinded trial assessing patient and clinical outcomes of Viscoseal injection after meniscal surgery
IRAS ID
272362
Contact name
Cristian Nita
Contact email
Sponsor organisation
North Cumbria Integrated Care NHS Foundation Trust
ISRCTN Number
ISRCTN10972486
Clinicaltrials.gov Identifier
cp19xx, cp19xx
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
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. 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.
REC name
Wales REC 7
REC reference
19/WA/0357
Date of REC Opinion
22 Jan 2020
REC opinion
Further Information Favourable Opinion