Patient Specific Instrumentation in TKR

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096393
• Other study ID #: STH16313
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: June 18, 2020

Study information

• Verified date: June 2022
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Zimmer Patient specific instruments
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
Standard instrumentation will be used during total knee replacement surgery.

Locations

Country	Name	City	State
United Kingdom	Rotherham District General Hospitals NHS Trust	Rotherham	South Yorkshire
United Kingdom	Sheffield Teaching Hospital NHS Trust	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EUROQOL-5D		1 year, 5 years and 10 years
Other	IKKS Score	Questionnaire	1yr, 5 yr, 10yr
Primary	Implant alignment	Sagittal and coronal alignment of the knee arthroplasty implant will be measured on full length radiographs	6 weeks
Secondary	Oxford Knee Score	Patient questionnaire	1yr, 5yr, 10yr