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Validation of TKA Easy software: Are the clinical outcomes the same as the TKA 4.3 software?

Validation of TKA Easy software: Are the clinical outcomes the same as the TKA 4.3 software?: a randomised controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN71883082
Enrollment
220
Registered
2012-06-18
Start date
2012-02-08
Completion date
Unknown
Last updated
2019-02-11

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

Conditions

Navigated Total Knee Arthroplasty Musculoskeletal Diseases

Interventions

All patients will undergo a primary navigated TKA. Patients will be assessed at the pre-operative clinic, and an Oxford Knee Score will also be taken as part of their routine clinical

Sponsors

National Waiting times Centre Board (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients having a primary navigated knee arthroplasty 2. Able to give informed consent 3. Able to return for follow-up

Exclusion criteria

Exclusion criteria: 1. Patients with a body mass index (BMI) > 40 2. Patients who are known pre-operatively to require patellar resurfacing 3. Patients who do not wish to participate 4. Patients who are unable to give informed consent 5. Patients who are unable to attend for follow up

Design outcomes

Primary

MeasureTime frame
The overall lower limb coronal alignment (mechanical femorotibial angle) as measured on the post-operative CT scan

Secondary

MeasureTime frame
1. Radiological - Component alignment and rotation and sagittal lower limb alignment 2. Patient reported outcome measures - Oxford knee score and Patient Satisifaction 3. Clinical outcomes - Knee Society Score, range of motion, number of complications 4. Operative times - registration time and overall operative time

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026