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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15283289
Enrollment
100
Registered
2026-06-15
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis (OA) Musculoskeletal Diseases

Interventions

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 hydro

Sponsors

University Hospital Southampton NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Knee outcome measured using Oxford Knee Score at baseline, 6 months, 12 months and 24 months;Foot & Ankle outcome measured using Manchester-Oxford Score MOX-FQ at baseline, 6 months, 12 months and 24 months;Shoulder outcome measured using Oxford Shoulder Score at baseline, 6 months, 12 months and 24 months;Wrist outcome measured using DASH score at baseline, 6 months, 12 months and 24 months;Pain measured using visual analogue scale at baseline, 6 months, 12 months and 24 months;Quality of life measured using EQ5D at baseline, 6 months, 12 months and 24 months

Secondary

MeasureTime frame
Prevalence of complications & adverse events measured using patient notes at annual check up to two years follow-up following recruitment to the study;Requirement for additional treatments, including repeat injections or surgical intervention during the follow up period measured using patient notes at annual check up to two years follow-up following recruitment to the study

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactNiall Hill
niall.hill@nhs.scot+44 1698361100

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026