None listed
Conditions
Brief summary
This study will be a prospective, multicentre, clinical study examining clinical outcomes of Knee Replacement using the Oxford Knee Score (OKS), in patients receiving Total Knee Replacement using the Triathlon Total Knee System performed using Stryker’s robotic-arm assisted surgery system Mako. Functional and radiographic outcomes will be additionally collected as part of this study. The study will be conducted in patients with non-inflammatory degenerative joint disease who require a primary Total Knee Replacement, with a minimum 2 year patient evaluation period.
Interventions
Patients will recieve a Triathlon Primary Total Knee implant. The Stryker Triathlon Primary Total Knee System is made up of various individual implants of different designs, sizes and thicknesses. The study devices include the following and will be used in combination based on the surgeon preference for the patient;
*Cruciate Retaining (CR) or Posterior Stabilizing (PS) Femoral Cementless Component – Beaded with Peri-Apatite
*CR or PS Femoral Cemented Component
*CR, CS or PS Primary Tibial Base
Patients will recieve a Triathlon Primary Total Knee implant. The Stryker Triathlon Primary Total Knee System is made up of various individual implants of different designs, sizes and thicknesses. The study devices include the following and will be used in combination based on the surgeon preference for the patient; *Cruciate Retaining (CR) or Posterior Stabilizing (PS) Femoral Cementless Component – Beaded with Peri-Apatite *CR or PS Femoral Cemented Component *CR, CS or PS Primary Tibial Baseplate – Cemented *CR, CS or PS Primary Tibial Baseplate – Cementless *CR or PS Tibial Insert – X3 *Triathlon X3 Patella (cemented asymmetric/symmetric) Stryker's robotic-arm assisted surgery system Mako will be used in surgery. Duration of surgery is approximately 1.5hours and will be conducted by a qualified Orthopaedic surgeon at a hospital. Patient pre-operative and post-operative follow up visits will be conducted at the surgeons clinic rooms by a surgeon and a physiotherapist. 1 x pre-operative study visit will take place prior to surgery, and 3 x post-operative visits will take place at 3 months, 12 months and 24 months at the surgeons clinic. These visits will be conducted face to face with the surgeon and/or physiotherapist and should take less than 30 minutes in duration.
Sponsors
Stryker Australia Pty Ltd.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient is a suitable candidate for a Primary Total Knee Replacement (based on the Investigator’s clinical judgement). 2. The patient is a male or non-pregnant female. 3. The patient has signed the study specific, HREC-approved, Informed Consent document and is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations. 4. The patient is at least 18 years of age
Exclusion criteria
1. The patient is undergoing revision surgery 2. The patient has active, local infection or previous intra-articular infection 3. The patient has skeletal immaturity 4. The patient is without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis 5. The patient has a blood supply limitation 6. The patient has collateral ligament insufficiency 7. The patient had a prior High Tibial Osteotomy (HTO) 8. The patient’s weight, age or activity level might cause extreme loads and early failure of the system (surgeon’s discretion). 9. The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis), or patient is immunologically suppressed. 10. Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient’s capacity to consent to research and the ability to participate in it
Outcome results
None listed