Skip to main content
OpenTrials
Completed

NCT Number: NCT02096393

Patient Specific Instrumentation in TKR

This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rotherham District General Hospitals NHS Trust, Rotherham, South Yorkshire, United Kingdom

Loading trial locations.

About this study

This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The process is similar to traditional knee replacement surgery but approximately 6 weeks prior to the operation patients will undergo an MRI scan of their knee, hip and ankle. From this data the dimensions and rotation of the knee can be accurately measured, and a custom made jig can be made specific to that patients anatomy. The jig is used intra-operatively to make accurate bone cuts according to this pre-operative plan, the type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females aged 18-75 years at time of surgery.
  • Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the knee.
  • Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
  • Patients who signed the study consent form prior to surgery.

Exclusion criteria

  • Pregnant women.
  • Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
  • Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
  • Previous knee surgery including those already treated by with a total knee replacement (i.e. requiring a revision knee replacement).
  • Muscle contracture around the knee joint
  • Individuals with active or suspected infection or sepsis.
  • Patients with contraindication to MRI

Treatment and study plan

Zimmer Patient specific instruments

Device

A custom made cutting block will be used during total knee replacement surgery. The cutting block is made specific to patient's anatomy based on MRI scans taken 6 weeks prior to surgery.

Standard instrumentation

Device

Standard instrumentation will be used during total knee replacement surgery.

Primary outcomes

  1. Implant alignment

    Time frame: 6 weeks

    Sagittal and coronal alignment of the knee arthroplasty implant will be measured on full length radiographs

Secondary outcomes

  1. Oxford Knee Score

    Time frame: 1yr, 5yr, 10yr

    Patient questionnaire

Other outcomes

  1. EUROQOL-5D

    Time frame: 1 year, 5 years and 10 years

  2. IKKS Score

    Time frame: 1yr, 5 yr, 10yr

    Questionnaire

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

A Prospective, Randomised Control Trial Assessing Clinical and Radiological Outcomes of Patient Specific Instrumentation In Total Knee Arthroplasty

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2014
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.