Assessing the efficacy of polyacrylamide hydrogel which is injected into the joints of patients suffering from arthritis in their synovial joints (knee, shoulder etc) instead of steroid injections or joint replacement surgery
| ISRCTN | ISRCTN15283289 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15283289 |
| Integrated Research Application System (IRAS) | 356371 |
| Sponsor | University Hospital Southampton NHS Foundation Trust |
| Funder | University Hospital Southampton NHS Foundation Trust |
- Submission date
- 03/05/2026
- Registration date
- 15/06/2026
- Last edited
- 07/09/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis is a common condition that causes pain, stiffness, and reduced movement in joints such as the knee, shoulder, hip, or ankle. Many people are treated with pain relief medicines or steroid injections, and some may eventually need joint replacement surgery. This study is looking at whether a gel injection called polyacrylamide hydrogel can reduce pain and improve joint movement for people with osteoarthritis. The aim is to see if this injection could be a longer lasting and less invasive option than repeated steroid injections or surgery.
Who can participate?
Adults aged 18 years or over who have ongoing pain from osteoarthritis or other similar joint problems may be able to take part. Participants need to have symptoms that have not improved enough with standard treatments and where their clinician believes a joint injection is appropriate. People with joint infections, certain inflammatory joint diseases, recent surgery or injections to the same joint, or who are pregnant or breastfeeding will not be able to take part.
What does the study involve?
Participants will receive a single injection of polyacrylamide hydrogel into the affected joint as part of their usual NHS care. The injection will be guided by ultrasound, given under local anaesthetic, and carried out by trained clinicians using sterile techniques. After the injection, participants will be followed for up to two years. During this time, they will be asked to complete questionnaires about their pain, joint function, and quality of life. Most follow-up will be done remotely, so extra hospital visits are usually not needed. Information about any side effects, further treatments, or later surgery will also be collected.
What are the possible benefits and risks of participating?
Some participants may experience reduced pain, better movement, and an improved quality of life, although these benefits cannot be guaranteed. The risks are similar to those of standard joint injections and may include short term pain, swelling, or bruising at the injection site. Infection is rare. It is also possible that the injection may not improve symptoms.
Where is the study run from?
The study is run from University Hospital Southampton NHS Foundation Trust, with plans to include other hospitals across the United Kingdom.
When is the study starting and how long is it expected to run for?
The study is expected to start after ethics approval, with the first participants planned from December 2027. It is expected to run until January 2029.
Who is funding the study?
University Hospital Southampton NHS Foundation Trust (UK).
Who is the main contact?
Dr Togay Koc, togay.koc@uhs.nhs.uk
Contact information
Principal investigator, Scientific
University Hospital Southampton
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 2381205009 |
|---|---|
| togay.koc@uhs.nhs.uk |
Public
University Hospital Wishaw
50 Netherton St
Wishaw
Glasgow
ML20DP
United Kingdom
 ORCID ID |
0000-0002-9572-5631 |
|---|---|
| Phone | +44 1698361100 |
| niall.hill@nhs.scot |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Longitudinal study |
| Participant information sheet | 49465 PIS v1.0 05May2026.pdf |
| Scientific title | Intra-articular Polyacrylamide hydrogel for Synovial Joint Arthritis. A comprehensive review of the efficacy of Polyacrylamide hydrogel in patients for whom a steroid injection or arthroplasty is warranted |
| Study objectives | This study aims to assess the efficacy of intra-articular polyacrylamide hydrogel as a non-operative management for patients suffering from synovial joint osteoarthritis. This is an observational pilot study which aims to assess the efficacy of polyacrylamide hydrogel as an intra-articular injection in patients who are candidates for a corticosteroid injection or arthroplasty. This study aims to assess the efficacy of the intra-articular polyacrylamide hydrogel using patient reported outcome measures (PROMS) up to two years following administration of the injection and complications from this intervention to determine the efficacy of the intervention as an alternative to arthroplasty and steroid injections. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Osteoarthritis (OA) |
| Methodology | This study is a prospective observational clinical study designed to evaluate the safety, feasibility, and clinical effectiveness of ultrasound-guided intra-articular injection of polyacrylamide hydrogel for the treatment of symptomatic synovial joint arthritis. Adult patients attending participating surgeons’ outpatient clinics will be screened for eligibility during routine clinical care. Potentially eligible patients will be identified through clinical assessment and review of referral information. Potentially eligible patients will be provided with a Participant Information Sheet (PIS) by a member of the research team following identification in the outpatient clinic. The PIS will explain the purpose of the study, study procedures, potential risks and benefits, data handling arrangements, and the voluntary nature of participation. Participants will be given adequate time to read the information and consider whether they wish to participate. They will have the opportunity to ask questions and discuss the study with members of the research team before making a decision. Participation in the study is entirely voluntary. Patients will be informed that choosing not to participate, or withdrawing from the study at any time, will not affect their ongoing clinical care or their relationship with the clinical team. Written informed consent will only be obtained once the participant has had sufficient time to consider the information provided. Once consent has been obtained, participants will be enrolled in the study and the clinical team will proceed with the standard clinical pathway, including submitting a request for ultrasound-guided intra-articular injection as appropriate. Participants will undergo a single ultrasound-guided intra-articular injection performed by appropriately trained clinicians under local anaesthesia using established aseptic techniques. Prophylactic antibiotics will be administered where appropriate. Participants will be followed for up to two years following the intervention. Outcome data will be collected primarily through remote patient-reported outcome measures, including validated joint-specific functional scores, pain scores, and quality-of-life assessments. Information on complications, additional treatments, and any subsequent surgical interventions will also be collected. Data will be analysed using descriptive and appropriate inferential statistical methods to assess changes in outcomes over time and evaluate the safety profile of the intervention. Results will be reported in aggregate form. |
| Intervention type | Device |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Arthrosamid® |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 01/09/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Adults aged 18 years or over 2. Diagnosis of symptomatic synovial joint pathology considered suitable for intra-articular injection by the treating clinician. 3. Clinical and/or radiological evidence of joint disease affecting the target joint 4. Persistent symptoms despite standard conservative management, including pharmacological and/or non-pharmacological treatment where appropriate 5. Ability to understand the study requirements and provide written informed consent 6. Willingness and ability to comply with study procedures and follow-up assessments |
| Key exclusion criteria | 1. Age under 18 years 2. Active local infection at the injection site or systemic infection 3. Previous intra-articular injection to the target joint within the preceding 6 months 4. Previous surgery to the target joint within the preceding 6 months or planned surgery during the study period 5. Known hypersensitivity or contraindication to the study intervention, local anaesthetic, or antibiotic prophylaxis 6. Known coagulopathy or current anticoagulant therapy where injection is contraindicated 7. Diagnosis of inflammatory arthropathy (e.g., rheumatoid arthritis) or other systemic inflammatory joint disease affecting the target joint 8. Pregnancy or breastfeeding 9. Inability to complete study procedures or follow-up assessments 10. Any medical, psychological, or social condition which, in the opinion of the investigator, would make participation unsuitable or place the participant at undue risk 11. Only participants with capacity to provide informed consent will be included 12. Individuals lacking capacity to consent will not be recruited |
| Date of first enrolment | 01/12/2026 |
| Date of final enrolment | 01/09/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
- Wales
Study participating centre
Tremona Road
Southampton
SO16 6YD
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 05/05/2026 | 07/05/2026 | No | Yes |
Additional files
- 49465 PIS v1.0 05May2026.pdf
- Participant information sheet
Editorial Notes
07/09/2026: The date of first enrolment was changed from 01/09/2026 to 01/12/2026. The completion date was changed from 01/09/2028 to 01/09/2029.
15/06/2026: Trial's existence confirmed by University Hospital Southampton NHS Foundation Trust.
