Skip to content

A randomised controlled trial of different knee prostheses

A randomised controlled trial of different knee prostheses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45837371
Enrollment
2450
Registered
2003-04-25
Start date
1999-07-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Primary knee replacement surgery Musculoskeletal Diseases

Interventions

Current interventions as of 23/01/2009: The trial is evaluating four aspects of knee replacements: 1. Metal backing of the tibial component compared with a single high density polyethylene component (

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

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

Secondary

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

Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 21, 2026