None listed
Conditions
Brief summary
This is a prospective double-blind cross-sectional cohort study, assessing the difference in knee stability in the sagittal (forwards and backwards) between two commonly used implants, and the effect that this has on patient satisfaction. Patients with a primary diagnosis of knee osteoarthritis who are over 18 years of age and are booked for a TKA at Fremantle Hospital receiving either an AttuneTM or TriathlonTM primary knee replacement will be recruited. Patients will be recruited at their booking visit, and consenting participants will be asked to complete validated Patient Reported Outcome Measure (PROM) questionnaires. Sagittal stability will be objectively measured by a device called a GNRB arthrometer at 30 degrees and 90 degrees of knee flexion. 134N of force will be applied to the top of the shin bone whilst the thigh bone is held steady and anterior displacement of the tibia will be measured. Clinical evaluation of stability will occur through physical examination. Sagittal stability is defined according to the amount anterior translation of the tibia with <5mm deemed stable, 6-10mm partially unstable and >10mm unstable. Range of movement in flexion and extension will be assessed with a goniometer and recorded. Radiological assessment prior to their surgery will be routine as per all joint replacements; pre-operative alignment and post-operative alignment will be assessed with long-leg alignment views. Each surgeon involved will use only 1 prosthesis type for all participating patients under their care (TriathlonTM or AttuneTM) in line with current practice. Participants and the examiner performing assessment of sagittal stability will be blinded to implant type. All implant details (size, side, patella, polyethylene type, polyethylene thickness and patella resurfacing) will be explicitly recorded and tracked. Patients are randomly assigned to each surgeon according to the participating hospital's outpatient referral system, as is current practice. Pre-operative demographic analysis of patient characteristics will be used to screen for selection bias. TKA will be performed as per the surgeon’s preferred technique according to the manufacturer’s recommendations. Plain radiographs, PROMs and assessment of sagittal stability will be repeated at 6 weeks and 12 months follow up.
Interventions
This project will recruit patients receiving a total knee arthroplasty (TKA) at Fremantle Hospital who have already been determined by their treating surgeon as receiving one of two commonly used knee implant systems; TriathlonTM or AttuneTM. These implants are used for straightforward knee osteoarthritis, and the selection is based upon surgeon preference. Currently the participating surgeons in the department are split, with approximately 50% of surgeons preferring the TriathlonTM implants, an
This project will recruit patients receiving a total knee arthroplasty (TKA) at Fremantle Hospital who have already been determined by their treating surgeon as receiving one of two commonly used knee implant systems; TriathlonTM or AttuneTM. These implants are used for straightforward knee osteoarthritis, and the selection is based upon surgeon preference. Currently the participating surgeons in the department are split, with approximately 50% of surgeons preferring the TriathlonTM implants, and 50% preferring the AttuneTM implants. Participation in this study will not affect which implant patients receive, nor will it affect any aspect of their surgical treatment. The AttuneTM implant system is a highly congruent design, and TKA with this implant takes approximately 90 minutes. The clinical pathway for patients who participate in the study will differ only minimally from standard practice for TKA patients, in that they will undergo an additional objective assessment of their knee stability in the sagittal plane (forwards and backwards) with a device called a GNRB arthrometre. Examination with this device involves strapping the knee into the arthrometre, where 134N of pressure is applied to the top of the shin bone while the end of the thigh bone is held steady. The amount of backwards movement of the knee is measured objectively. This will occur with the knee in 20 degrees of flexion. 3 readings will be taken so that the average can be calculated. This examination will take approximately 10 minutes. Studies using this device have allowed participants to withdraw at any time if they find the examination uncomfortable, and no participants have elected to withdraw in these studies. This will occur preoperatively and at 6 weeks and 12 months follow up. Additionally, participants will be asked to complete patient reported outcome surveys preoperatively and at 6 weeks and 12 months follow up. Completion of 12 month follow up will conclude the participants commitment to the study.
Sponsors
Associate Professor Chris Jones
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients over 18 years of age who are booked for primary TKA to treat osteoarthritis at Fremantle Hospital, and consent to study participation.
Exclusion criteria
Patients: • Who have anatomy unsuitable for an Attune or Triathlon implant • With Rheumatoid Arthritis • Who are unable to provide consent, and/or unable to complete the satisfaction surveys • Who are pregnant
Outcome results
None listed