Clinical Utility and Gait Analysis of NextAR System AUS
ConditionTotal Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedacta International SA
About this trial
This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
End-stage osteoarthritis of the knee suitable for total knee arthroplasty.
Aged over 18 years.
Disqualifiers
Unsuitable for TKR due to chronic infection, medical disease, inability to consent, inability to attend for post-operative follow-up, significant psychiatric issues, substance abuse issues
Previous reconstructive/fracture/arthroplasty surgery on affected knee
Active inflammation arthropathy
Significant extra articular deformity
Trial population
The trial will include two groups of 50 patients in each group. This is based on a power calculation assuming a difference in Forgotten Join Score of greater than 5 points. This calculation allows for a loss to follow-up of 10%. The study will conclude once the patients involved have completed 2 years of follow-up.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Implantation of GMK Sphere with conventional instrumentation
DeviceImplantation of GMK Sphere with conventional instrumentation (control group)
Implantation of GMK Sphere using the NextAR guidance system
DeviceImplantation of GMK Sphere using the NextAR guidance system (NextAR group)
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: control study1 intervention
Group B: NextAR study1 intervention
Trial outcomes
Primary outcomes
1
Determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score
To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score \- Forgotten Joint Score measures the patient's ability to forget about the joint as a result of successful treatment and is based on the premise that the best arthroplasty is one the patient forgets. This score goes from a minimum of 0 to a maximum of 100 points.
Time frame
pre-op, 6 weeks, 6 months, 1 year, 2 yearsSecondary outcomes
1
To determine whether NextAR system data contributes to change patient outcomes using the EQ5D-5L
To determine whether NextAR system data contributes to change patient outcomes using the EQ5D-5L The EQ5D-5L comprises of 6 questions survey that measures generic health-related quality of life. This score goes from a minimum of 0 to a maximum of 1 points.
Time frame
pre-op, 6 weeks, 6 months, 1 year, 2 years2
Determining the kinematics of the replaced knee as measured by 3D gait analysis.
The purpose of the gait analysis will be to assess the variation in kinematics between the patients replaced knee (in both study groups) compared to normal knee kinematic data reported in the literature. The hypothesis being tested is that alteration of component position to give more normal ligament tension, will more resemble normal knee kinematics. (n=20) will be sufficient to conduct the gait analysis. These patients will be selected from the overall cohort for enrolment at 12 months post-surgery and matched for age, gender, BMI and osteoarthritis pattern. The comparison will involve comparing the average kinematic data values obtained in group 1 (NextAR data provided at surgery) vs the reported values in the literature and the same analysis will be repeated for patients in group 2 (NextAR data not provided at surgery).comparison will be made between the two groups in terms of which more closely replicates the kinematics of the non-arthritic knee
Time frame
pre-op, 1 year3
To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score
To determine whether NextAR system data contributes to change patient outcomes using the Oxford Knee Score the Oxford Knee Score is a questionnaire that has been specifically developed to assess knee function and pain. It is short, reproducible and extensively referenced in orthopaedic literature, making it a preferred tool for studies. This score goes from a minimum of 0 to a maximum of 48 points.
Time frame
pre-op, 6 weeks, 6 months, 1 year, 2 years4
To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score using the International Knee Documentation Committee
To determine whether NextAR system data contributes to change patient outcomes using the Forgotten Joint Score using the International Knee Documentation Committee International Knee Documentation Committee is questionnaire that evaluates physical activity, level of pain and knee functionality in sporting activities. This score goes from a minimum of 0 to a maximum of 100 points.
Time frame
pre-op, 6 weeks, 6 months, 1 year, 2 yearsSponsors and contacts
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Source ClinicalTrials.gov