HATCAT Trial
Research type
Research Study
Full title
RCT of Hyaluronic Acid for Treatment of Chronic Achilles Tendinopathy (HATCAT) Randomized controlled trial of a single, image-guided, intra-sheath (paratenal) injection of 10 ml 0.5% Hyaluronic Acid (Viscoseal) versus an injection of 10 ml 0.9% saline (current practice) on pain and function for treatment of chronic Achilles tendinopathy.
IRAS ID
221091
Contact name
Scott Middleton
Contact email
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Achilles tendinopathy is a common and potentially stubborn problem. It is estimated to effect 2.35 per 1000 people in the UK, equivalent to over 150,000 people in the UK every year
The majority of patients will be satisfactorily treated with conservative measures including physiotherapy and exercise regimens. However, the patients seen in clinic by orthopaedic surgeons have frequently exhausted these options and require additional treatment. There are many different treatment options available through surgery, but there is growing evidence that these tendinopathies may be treated effectively with injections of hyaluronic acid (HA) performed in clinic. There is moderate evidence to support this in the achilles region, and even greater evidence for similar conditions in other areas of the body (such as the shoulder or elbow).
All patients presenting to the outpatient clinic will be provided with information regarding the trial so they can make an informed decision about taking part. If they do not wish to take part, they will receive the usual standard of care: this would consist of a saline injection performed under the guidance of ultrasound scanning.
The primary aim of the trial is to assess the benefit derived from an injection of 10ml hyaluronic acid. Patients who have failed at least 3 months of conservative management will be randomised to receive either an injection of Viscoseal (10 ml 0.5% HA) or an injection of sodium chloride of the same volume, under ultrasound guidance. Patient reported outcome measures (explained in full in A10) - VAS, SF12, VISA-A (Achillies) - at baseline, 4 weeks and 12 weeks will be measured - and ultrasound imaging at baseline and 12 weeks will be performed.
Funding is provided (only to covers cost incurred) by the same company which is providing the medication. It should be noted that the principal investigators have no conflicts of interest to declare.
REC name
South East Scotland REC 02
REC reference
18/SS/0054
Date of REC Opinion
19 Jun 2018
REC opinion
Further Information Favourable Opinion