Hyaluronate [Viscoseal] injection after knee surgery; an evaluatio
- Conditions
- Elective orthopaedic surgerySurgery
- Registration Number
- ISRCTN10972486
- Lead Sponsor
- orth Cumbria University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 52
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evel 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
Name Time Method <br> 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<br> 2. Visual display score pain scale for knee (walking) at baseline, and post-surgery at 12 weeks and 26 weeks<br> 3. Pain description through McGill pain questionnaire at baseline, and post-surgery at 48 hours, 7 days, 14 days<br> 4. Girth size of the affected leg at baseline, and post-surgery at 14 days and 12 weeks<br> 5. Quality of life-related to meniscus function (Lysholme and WOMET surveys) at baseline, and post-surgery at 12 weeks and 26 weeks<br> 6. Patient satisfaction with the surgical procedure through a survey at week 26<br> 7. Optional MRI sub-study: radiological description of meniscal health at 26 weeks post-surgery<br>