None listed
Conditions
Brief summary
This is a bone mineral density (BMD) study using a dedicated analysis protocol to compare bone density around the surgical knee implant. in total knee arthroplasty (TKA). Patients with osteoarthritis will be recruited prior to their TKA operation by their treating surgeon. Patients who participate have an equal chance of being allocated to the Triathlon cemented baseplate or the Triathlon cementless baseplate (Tritanium). Clinical information, such as age, height, weight, ethnicity, general health, medications and medical conditions will be collected. Patient reported outcomes, functional activity, pain and adverse events will also be recorded. The study involves four visits to Monash Medical Centre in Clayton which are additional to routine clinical appointments: before the operation, 6-weeks after, 12 months after and finally 24 months after the operation.
Interventions
This trial assesses two types of total knee arthroplasty (TKA). Surgical intervention will be randomly allocated to participants (knee surgery patients with osteoarthritis of the knee). Participants will receive either the cemented or cementless device during their surgery.
The femoral component is manufactured from a Cobalt Chromium alloy whilst the tibial component is manufactured via a 3D printing process from Titanium powder. All bearing surfaces (patella and tibial insert) are manufactured
This trial assesses two types of total knee arthroplasty (TKA). Surgical intervention will be randomly allocated to participants (knee surgery patients with osteoarthritis of the knee). Participants will receive either the cemented or cementless device during their surgery. The femoral component is manufactured from a Cobalt Chromium alloy whilst the tibial component is manufactured via a 3D printing process from Titanium powder. All bearing surfaces (patella and tibial insert) are manufactured from ultra-high molecular weight polyethylene and treated through a 3 stage sequential crosslinking and annealing process. Their treating surgeon will perform the operation, with a usual surgery duration of approximately one hour. The cemented devices used in this trial are listed below. Cemented TKA system: -Triathlon CR Cemented Femoral Component (5510-F-XXXX) – ARTG 212698 -Triathlon Cemented Tibial Baseplate (5520-B-XXX) – ARTG 217832 -Triathlon CR Tibial Insert - X3 (5530-G-XXX) – ARTG 216480 -Triathlon CS Tibial Insert - X3 (5531-G-XXX) – ARTG 218019 -Triathlon symmetric patella – X3 (5550-G-XXX) – ARTG 212702 -Triathlon asymmetric patella – X3 (5551-G-XXX) – ARTG 212701 Any surgical complications and side effects will be reported in the patient's medical notes by the treating surgeon and followed-up as needed, using the surgeon's clinical judgement.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient is a male or non-pregnant female. 2. The patient suffers from osteoarthritis. 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 a suitable candidate for a Cruciate Retaining cementless TKA (based on the Investigator’s clinical judgment). 5. The patient only requires uni-lateral TKA (rather than bilateral TKA).
Exclusion criteria
1. 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 the patient is immunologically suppressed. 2. The 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