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A Randomised Control Trial Comparing Functional Outcomes for Navigated Kinematically Aligned TKR Versus Navigated Mechanically Aligned TKR

ConditionKinematical Alignment,Mechanical Alignment, Navigation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorHull University Teaching Hospitals NHS Trust

About this trial

The overall aim of the study is to compare navigated kinematically aligned total knee replacements (KA TKR) with navigated mechanically aligned TKR (MA TKR) in terms of function and ROM

The objectives are therefore:

1. To compare the functional outcomes of KA TKR versus MA TKR performed using navigation technique 2. To compare ROM and alignment of knee in the two groups

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• Age between 18 and 90 years

Diagnosis of degenerative osteoarthritis

Disqualifiers

o a)Post traumatic arthritis

b)Varus /valgus deformity of more than 20 degrees

flexion contracture of more than 20 degrees

reduced ability to make decision like dementia patients/children

Trial design

Design model

Parallel

Treatments tested in this trial

  • alignment types

    Procedure/Surgery

    types of alignment mechanical versus kinematic of TKA to be studied

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: kinematically alignmentActive comparator 1 intervention
Group B: mechanical alignmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

KOOS

knee osteoarthritis outcome score preop and at 12 months

Time frame
12 months

Secondary outcomes

1

• Knee ROM and stability (pre-op and at 1 year postop)

to be checked by independent assessor

Time frame
1 year
2

• Oxford knee society score

patient based outcomes

Time frame
1 year
3

• SF-12

patiuent based outcomes

Time frame
1 year
4

• EQ5D

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hull University Teaching Hospitals NHS Trust

Lead sponsor

Source ClinicalTrials.gov
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