Condition category
Surgery
Date applied
10/02/2020
Date assigned
05/03/2020
Last edited
05/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
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.

Who can participate?
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).

What does the study involve?
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.

What are the possible benefits and risks of participating?
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.

Where is the study run from?
Cumbria Partnership NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
January 2020 to July 2021

Who is funding the study?
TRB Chemedica (UK) Ltd.

Who is the main contact?
Dr Leon Jonker
leon.jonker@nihr.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Leon Jonker

ORCID ID

Contact details

North Cumbria Integrated Care NHS Foundation Trust
R&D Dept
Carleton Clinic
Carlisle
CA1 3SX
United Kingdom
+44 (0)1228 608926
leon.jonker@nihr.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 43835, IRAS 272362

Study information

Scientific title

A single-centre, randomised, placebo-controlled single-blinded trial assessing patient and clinical outcomes of Viscoseal injection after meniscal surgery

Acronym

HIKE

Study hypothesis

To determine the level of index leg related pain experienced at day 7 post-operation and to compare the average pain scores of patients in the control and Viscoseal arm respectively, through administration of 100 mm visual descriptor scale (VDS) for pain at rest.

Ethics approval

Approved 22/01/2020, NHS HRA Wales REC 7 (c/o Public Health Wales, Building 1, Jobswell Road, St David’s Park, SA31 3HB, UK; +44 (0)1267 611 164; sue.byng@wales.nhs.uk), ref: 19/EM/0363

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Elective orthopaedic surgery

Intervention

- Standard care (control) arm
All patients receive general anesthesia and a pneumatic tourniquet is used. Patients are already randomised prior to surgery to avoid delays with surgery and allow a vial of Viscoseal to be ready for the relevant patients. Joint irrigation is performed with the assistance of a manual arthroscopic pump using 0.9% NaCl solution at room temperature. Then, the remaining fluids are drained from the knee. At the end of the surgery, the knee is dressed while the tourniquet is still inflated. All surgeries are intended to be performed in a day-surgery facility with the patient being discharged the same day. Postoperatively, partial weight-bearing with crutches is allowed. Crutches are recommended for the first 48 hours, primarily for patient safety by minimising the risk of a fall.

- Viscoseal (intervention) arm
Apart from the difference in terms of Viscoseal administration to the intervention group, the surgical protocol for the Viscoseal arm is identical to that of the standard care group. At the end of the surgery, again all the remaining fluids are drained from the knee, but this is followed by injection of 10 mL of Viscoseal preparation. Used Viscoseal product and syringes will be disposed of in line with local guidelines on disposal of clinical waste.

Timeline and overview of different study visits
Visit 1# Pre-surgery (<0 weeks)
Written Informed Consent, Collection of baseline information (age, weight etc), Record use of any pain medication, Limb girth measurement, Validated patient-reported outcome measures (Lysholm scale; WOMET tool; Visual display scale for knee pain)

Visit 2# Day of surgery (day 0)
No research activity, apart from injection of Viscoseal if patient is randomised to this treatment arm (patient will not know if given Viscoseal or not)

Visit 3# , Day 2
Record use of any pain medication, Limb girth measurement, McGill pain questionnaire, Validated patient-reported outcome measures (Visual display scale for knee pain)

Visit 4# Day 7
Record use of any pain medication, Limb girth measurement, McGill pain , questionnaire, Validated patient-reported outcome measures (Visual display scale for knee pain)

Visit 5# Day 14
Record use of any pain medication, Limb girth measurement, McGill pain questionnaire, Validated patient-reported outcome measures (Visual display scale for knee pain)

Visit 6# Week 12
Record use of any pain medication, Validated patient-reported outcome measures (Lysholm scale; WOMET tool; Visual display scale for knee pain), Patient satisfaction questionnaire

Visit 7# Week 26
Record use of any pain medication, Validated patient-reported outcome measures (Lysholm scale; WOMET tool; Visual display scale for knee pain), Patient satisfaction questionnaire

MRI-substudy: one additional (optional) standard MRI scan of the knee at week 26

Intervention type

Other

Phase

Drug names

Primary outcome measure

Level of index leg related pain experienced at day 7 post-operation measured using 100 mm visual descriptor scale (VDS) for pain at rest. The study is powered to detect the established minimal clinically important difference (MCID) of 15 mm on a 100 mm VDS pain.

Secondary outcome measures

1. Visual display score pain scale for knee (at rest) at baseline, and post-surgery at 48 hours, 7 days, 14 days, 12 weeks and 26 weeks
2. Visual display score pain scale for knee (walking) at baseline, and post-surgery at 12 weeks and 26 weeks
3. Pain description through McGill pain questionnaire at baseline, and post-surgery at 48 hours, 7 days, 14 days
4. Girth size of the affected leg at baseline, and post-surgery at 14 days and 12 weeks
5. Quality of life-related to meniscus function (Lysholme and WOMET surveys) at baseline, and post-surgery at 12 weeks and 26 weeks
6. Patient satisfaction with the surgical procedure through a survey at week 26
7. Optional MRI sub-study: radiological description of meniscal health at 26 weeks post-surgery

Overall trial start date

22/11/2019

Overall trial end date

01/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Meniscal surgery of the knee for meniscal tear grade III (including repair, partial meniscectomy or complete meniscectomy)
2. Aged 18 – 59 years
3. Proficient in English (reading and writing, due to surveys used)
4. Mental capacity to consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 52; UK Sample Size: 52

Participant exclusion criteria

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 drugs
4. Inflammatory arthropathy
5. 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 clinician
6. 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

Recruitment start date

22/01/2020

Recruitment end date

01/01/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

North Cumbria University Hospitals NHS Trust

Sponsor details

Voreda House
Portland Place
Carlisle
CA11 7BF
United Kingdom
+44 (0)1228 608926
dave.dagnan@ncic.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

TRB Chemedica (UK) Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/03/2020: Uploaded protocol (not peer reviewed) as an additional file. 11/02/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).