Targeting synovitis in knee osteoarthritis

Phase 4

Completed

• Conditions: Topic: Musculoskeletal, Primary Care Research Network for England; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases; Musculoskeletal Diseases; Knee osteoarthritis

• Registration Number: ISRCTN07329370
• Lead Sponsor: Salford Royal NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-21
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age 40 - 79 years
2. Male or female
3. Ambulatory (not wheelchair bound)
4. Able and willing to attend or comply with intervention and follow up
5. Within the last 24 months:
5.1. Radiological (X-ray) evidence of grade 2 or more OA
5.2. Evidence of significant OA on MRI scan
5.3. Documented evidence of at least grade 2 arthritis on arthroscopy
6. Moderate knee pain lasting 48 hours in the past 2 weeks
7. Presence of clinically apparent knee effusion
8. Written informed consent
9. Glomerular filtration rate (GFR) greater than 44 ml/min

Exclusion Criteria

1. Secondary OA - septic arthritis, gout
2. History of inflammatory arthritis
3. Previous intra-articular Ostenil or steroid injection within 6 months
4. Previous knee surgery (including cartilage surgery) or arthroscopy within 6 months
5. Inability to understand the procedures
6. Pregnancy
7. Chronic kidney disease with estimated glomerular filtration rate (eGFR) greater than or equal to 44 ml/min
8. Concurrent life threatening illness
9. Implants which prohibit safe use of MRI scan including cochlear implants/metal objects in the body including joint prosthesis, cardiac or neural pacemakers, hydrocephalus shunts, intrauterine device or coil
10. Known hypersensitivity to Depomedrone or any components of its excipients
11. Systemic infection (unless specific anti infective therapy is employed)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in knee pain, analysis will focus on whether change in pain level from baseline to one week after the injection is given

Secondary Outcome Measures

Name	Time	Method
1. Visual Analogue Scale (VAS) - global knee pain<br>2. VAS - pain on nominated activity<br>3. VAS - wellness<br>4. Knee injury and Osteoarthritis Outcome Score (KOOS) subscales<br><br>Data collected at each study visit, baseline, week 1 and 1 x follow-up.