Patient Specific Instrumentation in TKR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2020-06-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Patient specific instrumentation

The patient will undergo using patient specific instrumentation

Group Type EXPERIMENTAL

Zimmer Patient specific instruments

Intervention Type 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

The patient will undergo surgery using standard instrumentation

Group Type ACTIVE_COMPARATOR

Standard instrumentation

Intervention Type DEVICE

Standard instrumentation will be used during total knee replacement surgery.

Interventions

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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.

Intervention Type DEVICE

Standard instrumentation

Standard instrumentation will be used during total knee replacement surgery.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No