RecruitingACTRN12621001243808

Shapematch study (Kinematic vs Mechanical Alignment Total Knee Replacement): A 10 year follow up study

A 10 year follow-up, longitudinal study of the clinical and radiographic outcomes of ShapeMatchNZRCT-10 participants who received a Stryker Triathlon® Custom Fit Knee® using either Stryker PrecisioN Knee Navigation or OtisMed® ShapeMatch® Technology

Sponsor

North Shore Hospital Waitemata DHB

Enrollment

95 participants

Start Date

Jan 18, 2022

Study Type

Observational

Conditions

Osteoarthritis of the knee

Summary

This is a 10 year follow up, longitudinal study of the clinical and radiographical outcomes of patients who participated in ShapeNZRCT-10 in 2011. In ShapeNZRCT-10, participants received a Stryker Triathlon® Total Knee System for Total Knee Arthroplasty (TKA) implanted using either Stryker OtisMed® ShapeMatch® Technology (intervention) or Stryker PrecisioN v4.0 Knee Navigation (control). For the purpose of this extended follow up study, we are looking to answer the following questions: (1)Are 10-year patient-reported outcome scores (PROMS) comparable in patients allocated to the intervention group compared to the control group? (2)Is there a difference in the long-term (10 year) survivorship of the prosthesis between the techniques? (3)Is there a difference in the revision/re-operation rate and the proportion of patients that experienced complications between the two techniques? (4)Is there a difference in radiolucent lines between the two techniques? There will be 2 sites (North Shore Hospital, Auckland and Waitakere Hospital, Waitakere), 1 Principal Investigator and 3 co-Investigators for this study. Approximately 95 patients will participate in the study. Total duration of the study is expected to be 2 year. The study consists of two groups: Intervention Group: Treatment by total knee replacement with a target lower limb alignment determined using preoperative imaging and kinematic alignment; Control Group: Treatment by total knee replacement with a target lower limb alignment equal to neutral Mechanical Axis. All participants will be requested to attend an outpatient visit as part of the study. At the visit, participants will complete assessments relating to quality of life, pain and functional outcome. In addition, participants will have standard knee X-rays taken. Data will also be captured on the secondary objectives of revision rate.

Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

Total knee replacement is one of the most common surgeries performed for severe knee arthritis. Two different techniques are used to align the new joint: mechanical alignment (targeting a straight, neutral leg axis) and kinematic alignment (targeting a position that more closely matches your natural knee anatomy). Both are established techniques, but it is not known whether one leads to better long-term results than the other. This study is a 10-year follow-up of approximately 95 patients who took part in an earlier trial where they received one of these two approaches in New Zealand. Researchers want to know whether either technique leads to better pain, function, or quality of life outcomes a decade after surgery, and whether there are differences in how long the implant lasts or how often re-operations are needed. Participants are people who were already enrolled in the original 2011 trial (ShapeMatchNZRCT-10), still have their original implant in place, and are willing to attend a follow-up clinic appointment for questionnaires and knee X-rays. People who have had revision surgery or who have significant cognitive difficulties are not eligible.

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Interventions

For patients requiring a total knee replacement a method was developed in hope of improving patient satisfaction levels in terms of function and pain after surgery. Instead of using conventional measuring and cutting equipment and computer-assisted navigation (Control Group), patient-specific cutting guides were manufactured based on pre-operative Magnetic Resonance Imaging (MRI) scans of the patient's leg (Intervention Group). Patients from ShapeMatchNZRCT-10 had a total knee replacement 10 years ago. These replacements were performed using the cutting guides which aligned the patient’s prosthesis according to their natural leg alignment (as opposed to the convention way where the patient’s leg was aligned according to a mechanical axis of 0 degrees). For this study, patients that were involved in ShapeMatchNZRCT-10 will be asked to attend a 10 year follow up out-patient clinic visit. At this 2-3 h single visit, participants will complete assessments relating to quality of life, pain and functional outcome. In addition, participants will have standard knee X-rays taken for radiographic evaluations.

Locations(1)

New Zealand

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ACTRN12621001243808

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