Alignment in Total Knee Replacement: A Randomised Controlled Study Comparing Intramedullary Alignment Systems with Patient Specific Instrumentatio

Not Applicable

• Conditions: Osteoarthritis of the Knee and Total Knee Replacement Surgery; Surgery - Surgical techniques; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12611000698976
• Lead Sponsor: Smith and Nephew

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Osteoarthritis of the Knee

Exclusion Criteria

Unable to have MRI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We aim to assess the overall alignment of the prosthesis between the group using standard intramedullary alignment systems and the second group using the patient specific instruments (Visionaire). Post-op the patients will undergo a CT scan (Perth Protocol) in order to establish the position of the prosthesis in relation to the femur and tibia.[CT scan will be carried out as an inpatient post-op but timing of this is not relevant as we are assessing a static component position within the bone.]

Secondary Outcome Measures

Name	Time	Method
Expense[Assessing the expense will involve looking at cost of sterilisation of instruments compared to patient specific instruments and also length of stay for patient in terms of bed days. This process will be priced as operative costs and post-op care estimated after patient discharged.];Operating Time[Completion of closure of the wound and tourniquet release.]