Assessing the safety of removing the inflamed joint lining tissue during knee replacement surgery

Completed

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN31010214
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Trust

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30151238

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-10-07
• Study Start: 2016-10-06
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 18 years or older
2. Female and male
3. End stage osteoarthrtitis of the knee requiring arthroplasty

Exclusion Criteria

1. Refusal or inability to provide informed consent
2. Bilateral synchronous procedures
3. Osteoarthritis secondary to auto-immune arthropathy
4. Inability to answer questionnaires due to cognitive impairment
5. Neuromuscular disorders that would perturb rehabilitation
6. BMI more than 40

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean haemoglobin decrease from pre-operatively to day one post-operatively

Secondary Outcome Measures

Name	Time	Method
1. Range of movement, measured by a research physiotherapist using a goniometer<br>2. Osteoarthritis symptoms, measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC)<br>3. Quality of life, measured using the Short Form Health Survey (SF-36)<br>4. Health status, measured using the EuroQol five dimensions questionnaire (EQ-5D)<br>5. Patient satisfaction from surgery score<br>All measured pre-operatively, 6 weeks post-operatively and 1 year post-operatively.