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What are the treatments and outcomes of people with obesity and severe knee osteoarthritis?

Obesity and arthritis of the knee study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN42984928
Enrollment
400
Registered
2024-10-29
Start date
2024-12-01
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Knee osteoarthritis Musculoskeletal Diseases

Interventions

Qualitative interview study: We will recruit approximately 12 participants with obesity and severe knee arthritis using a purposive sampling technique. Attainment of data saturation will inform the ex

Sponsors

University of Warwick
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: For the cohort study: 1. Referral from primary care to secondary or intermediate care services for their knee. 2. Severe arthritis as assessed by the treating clinician which can be defined as KL grade 4 primary knee arthritis (severe) in any knee compartment on a knee radiograph (x-ray) OR clinician deems arthritis severe enough to warrant a TKR. 3. BMI =35 kg/m² 4. Aged over 18 years 5. Has capacity to consent to being in a research study 6. Sufficient English language skills to understand study materials and respond to questionnaires For the qualitative study with patients: As above For the cross-sectional study: 1. Any BMI 2. KL grade 4 primary knee arthritis (severe) in any knee compartment

Exclusion criteria

Exclusion criteria: 1. Presence of inflammatory arthritis 2. History of intra-articular fracture causing post-traumatic arthritis 3. Previous surgery on the ipsilateral knee only an exclusion criteria if implants were inserted 4. Unable or unwilling to comply with follow up procedure 5. Unable to provide informed consent (e.g does not have capacity to consent) 6. Insufficient English language skills to understand study materials and respond to questionnaires

Design outcomes

Primary

MeasureTime frame
Oxford Knee Score at 12 months

Secondary

MeasureTime frame
Recorded at baseline, 12 months and 24 months: 1. Height and weight, which will be used to calculate BMI. This will be measured and recorded by a member of the research team. 2. OKS-APQ (activity participation score) a PROM which was developed as an adjunct to the OKS. The purpose of the APQ is to combat the issue with ceiling effect of the OKS when used alone. 3. Body-Q, a PROM which was developed for use by people with obesity undergoing weight loss interventions. It measures four domains (appearance, eating-related concerns, health-related quality of life and experience of care). An international multi-disciplinary consensus meeting identified which constructs were most important to measure and identified BODY-Q as the PROM instrument which best measured 6 out of 8 of the most important domains. Furthermore, a systematic review of the most suitable instrument for bariatric surgery identified BODY-Q as the instrument with the strongest evidence for content validity. 4. Euro-Qol-5D-5L (EQ-5D-5L) as a measure of health-related quality of life. It is a score assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (5 dimensions). 5. Generalised self-efficacy (GSE) scale 6. Hospital Anxiety and Depression Scale (HADS)

Countries

England, United Kingdom

Contacts

Public ContactFatema Dhaif
fatema.dhaif@warwick.ac.uk+44 2476963587

Outcome results

None listed

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