None listed
Conditions
Brief summary
This is a prospective, randomized, longitudinal study of the clinical outcomes of patients with medial compartment osteoarthritis of the knee treated by two different philosophies for knee joint replacement. Participants will be treated using either the Stryker MAKO Unicompartmental Knee Replacement (UKR) using Robotic surgery (intervention) or the Stryker Triathlon Total Knee System for Total Knee Arthroplasty (TKA) implanted using Stryker PrecisioN v4.0 Knee Navigation (control). When compared to TKA, UKR knees have fewer complications, shorter hospital stay, better patient satisfaction, and a faster return to work. The downside to UKA is a higher revision rate when compared to TKA, particularly if components are implanted incorrectly. UKA surgery is more technically demanding than TKA, and errors in component positioning or ligament balancing can contribute to early failure. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each followup interval. An economics analysis will also be conducted to compare costs associated with each technology platform. A maximum of 65 cases will be enrolled in each group, for a total of 130 patients. It is expected that participants will be recruited over a 24 month period. Initial data analysis will occur at two year follow up, thus the total duration of the initial phase of the study is expected to be 4 years. Further follow up to monitor implant durability will continue for 10 years. All participants (control and intervention groups) will be requested to attend visits preoperatively and postoperatively at 6 weeks, 6 months, 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. Participants will have standard knee Xrays taken preoperatively and postoperatively.
Interventions
This is a prospective, randomized, longitudinal study of the clinical outcomes of patients with medial compartment osteoarthritis of the knee treated by two different philosophies for knee joint replacement. Participants will be treated using either the Stryker MAKO Unicompartmental Knee Replacement (UKR) using Robotic surgery (intervention) or
the Stryker Triathlon Total Knee System for Total Knee Arthroplasty (TKA) implanted using Stryker PrecisioN v4.0 Knee Navigation (control).
The Stryker
This is a prospective, randomized, longitudinal study of the clinical outcomes of patients with medial compartment osteoarthritis of the knee treated by two different philosophies for knee joint replacement. Participants will be treated using either the Stryker MAKO Unicompartmental Knee Replacement (UKR) using Robotic surgery (intervention) or the Stryker Triathlon Total Knee System for Total Knee Arthroplasty (TKA) implanted using Stryker PrecisioN v4.0 Knee Navigation (control). The Stryker MAKO UKR replaces the medial knee joint, using robot assistance for accurate cuts than if performed manually by a surgeon. The technique adds approximately 10 minutes to the procedure therefore the total time of the operation will be approximately 90 minutes. With better positioning of the implant, better outcomes are expected. The operations will be performed by consultant orthopaedic surgeons.
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
45 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
The patient is a male or female over the age of 45 years. 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. Patient is deemed appropriate for a UKR knee replacement by the following parameters. The patient has a primary diagnosis of osteoarthritis (OA) of the medial compartment with exposed bone on both the tibia and femur . The patient has a functioning ACL ligament. Full thickness and good quality lateral cartilage present Correctable varus deformity of the knee
Exclusion criteria
Intra-operative findings of significant damage to the patella-femoral joint, especially of the lateral facet The patient is morbidly obese with BMI greater than 40. The patient has significant virus or valgus deformity more than 15 degrees The patient has a fixed flexion deformity more than 15 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. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements. Patient has previously had septic arthritis of the knee Patient has had previous surgery to the same knee such as ligament reconstruction, any form of joint replacement, or osteotomy around the knee.
Outcome results
None listed