A randomised controlled trial of different knee prostheses

Not Applicable

Completed

• Conditions: Primary knee replacement surgery; Musculoskeletal Diseases

• Registration Number: ISRCTN45837371
• Lead Sponsor: Department of Health (UK)

Brief Summary

2009 Results article in http://www.ncbi.nlm.nih.gov/pubmed/19122088 Baseline characteristics, and 2-year functional outcomes 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22290396 cost-effectiveness analysis results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24679222 Clinical effectiveness and cost-effectiveness after a median of 10 years follow-up

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-04-25
• Study Completion: 2023-06-30
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2450

Inclusion Criteria

Added as of 23/01/2009:
1. A decision has been made to have primary knee replacement surgery
2. The surgeon has no clear preference for a specific option in at least one of the comparisons
3. Both males ane females, no age limits

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 23/01/2009: <br>Oxford Knee Score (postal questionnaire) at 3 months and then annually thereafter. <br><br>Previous primary outcome measures: <br>Outcomes will be in terms of complications and patient-assessed pain and function, principally conducted by post. <br>Costings include those relating to <br>1. Early complications expected immediately post operatively from medical effects <br>2. Medium-term complications such as dislocation and infection <br>3. Late complications of wear, loosening and infection.

Secondary Outcome Measures

Name	Time	Method
Added as of 23/01/2009: <br>Complications and patient-assessed pain and function, assessed principally by postal questionnaires including: <br>1. SF-12 <br>2. EQ-5D <br>3. Questions about any further hospital admissions and surgery <br>4. Costings: <br>4.1. Early complications expected immediately post-operatively from medical effects <br>4.2. Medium-term complications such as dislocation and infection <br>4.3. Late complications of wear, loosening and infection <br><br>Questionnaires are completed at 3 months and then annually thereafter.