None listed
Conditions
Brief summary
This prospective, randomized, longitudinal clinical trial is to assess the early durability and clinical reliability of a highly porous metal tibial component versus a traditional cemented modular tibial component in Total Knee Replacement (TKR). We are looking to answer the following questions: (1) Is TKA with an uncemented highly porous metal tibial component as reliable clinically as TKR with a cemented tibial component (as judged by health status and functional outcome measures, complications, and reoperations)? (2) Is TKR with an uncemented highly porous metal tibial component as durable as TKA with a standard cemented tibial component (as judged by 5-year survivorship)? There will be 1 site (North Shore Hospital, Auckland), 1 Principal Investigator and 6 co-Investigators for this study. A maximum of 160 cases will be enrolled in each group, for a total of 320 patients. It is expected that participants will be recruited over a 24 month period. Total duration of the study is expected to be 10 years. The study consists of two groups: 1. Intervention Group: Treatment by total knee replacement using Stryker Triathlon uncemented TKR with uncemented patellar resurfacing; 2. Control Group: Treatment by total knee replacement using Stryker Triathlon Cemented TKR with cemented patellar resurfacing Pre-operatively, all participants will be required to have standard Knee X Rays (AP/M-L and Skyline view of patella. All participants (control and intervention groups) will be requested to attend visits pre- operatively and post-operatively at 6 weeks, 12 months, 24 months, 5 years and 10 years. At these visits participants will complete assessments relating to quality of life, pain and functional outcome. In addition, participants will have standard knee X-rays taken pre- operatively and post-operatively. A further follow up visit at 5 and 10 years, to collect longer term data on radiographic and patient outcomes including the secondary objectives of revision rate, device-related adverse events and re-operation rates.
Interventions
This is a prospective, randomized, longitudinal study of the clinical outcomes of patients with osteoarthritis of the knee treated by two different philosophies for knee joint replacement. Participants will be treated using either the Stryker cemented or uncemented Triathlon Total Knee System for Total Knee Arthroplasty (TKA). The approximate duration of the procedure is 90 minutes and will be performed by consultant orthopaedic surgeons. For both knee systems the surgical technique is the same,
This is a prospective, randomized, longitudinal study of the clinical outcomes of patients with osteoarthritis of the knee treated by two different philosophies for knee joint replacement. Participants will be treated using either the Stryker cemented or uncemented Triathlon Total Knee System for Total Knee Arthroplasty (TKA). The approximate duration of the procedure is 90 minutes and will be performed by consultant orthopaedic surgeons. For both knee systems the surgical technique is the same, but differ in whether cement is used at the bony interface or trabecular metal/porous metal gritted surface is used
Sponsors
North Shore Hospital Waitemata DHB
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The patient is a male or non-pregnant female between the ages of 40-75 years. * Patient is deemed appropriate for a cruciate retaining knee replacement. * The patient has a primary diagnosis of osteoarthritis (OA). * The patient has intact collateral ligaments. * The patient has signed the study specific, ethics-approved, Informed Consent document. * The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Exclusion criteria
* The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint. * Patient has had a previous osteotomy around the knee. * The patient is morbidly obese (BMI greater than 41). * The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System. * The patient has a varus/valgus malalignment greater than 20 degrees (relative to mechanical axis). * The patient has a fixed flexion deformity greater than 20 degrees. * The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * The patient has a systemic or metabolic disorder leading to progressive bone deterioration or poor bone quality. * The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements. * Patient has a cognitive impairment, an intellectual disability or a mental illness. * Patients NOT undergoing patellar resurfacing * The patient is pregnant.
Outcome results
None listed