At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- MAKO™ Partial Knee Arthroplasty (device), Triathlon (Stryker) Total Knee Arthroplasty (device)
- How long the study runs
- Study runs about 40 months (dates as stated)
- About the drug or intervention
- MAKO™ Partial Knee Arthroplasty — device: The robotic-arm will be used to position a partial knee arthroplasty. · Triathlon (Stryker) Total Knee Arthroplasty — device: Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 50 Years to 75 Years
- Who
- All
- Number of participants
- 159
- Started
- 2024-08-26
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for osteo arthritis knee
- • NA - 159 participants
- • The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology
Who can take part?
- • Ages 50 Years to 75 Years
- • Diagnosed with osteo arthritis knee
Where?
- • Edinburgh - Nicholas Clement
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.
More detail
Unicompartmental knee arthroplasty (UKA) is an accepted surgical alternative to total knee arthroplasty (TKA) for patients with isolated medial compartmental joint disease with the potential advantages of accelerated recovery, improved functional outcomes and retention of anatomical knee kinematics. However, some surgeons continue to favour TKA over UKA due to a lower revision rate. The higher revision rates associated with UKA are thought to be primarily due to component malpositioning and postoperative limb malalignment. Robotic-arm assisted (r)UKA offers a greater level of precision of component positioning compared to manual UKA and more recently the survivorship of rUKA has been shown to be greater than manual UKA. Early functional outcomes following robotic UKA appear to be better than those observed after manual TKA. Therefore, the benefits of UKA could potentially be enjoyed by the patient without the increased risk of revision when compared to TKA for those with medical compartment disease. The primary aim of this study is to compare the early knee specific functional outcome of rUKA with manually performed (m)TKA when performed for patients with medial compartment osteoarthritis of the knee. A single centre randomised control trial will be carried out powered to the Oxford knee score.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Listed for elective primary TKA for end stage medial compartment osteoarthritis
- ✓Intact anterior cruciate ligament
- ✓Full thickness and good quality lateral cartilage
- ✓Correctable intra-articular varus deformity and intact medial collateral ligament
- ✓American Society of Anesthesiologists (ASA) grades 1 and 2
Who cannot take part
- ✗Varus deformity of \> 20 degrees
- ✗Fixed flexion of \>10 degrees
- ✗Patient is unable to comply with the study protocol (incl. refusal for CT scan) or functional assessments
- ✗Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- ✗Requires patella resurfacing or lateral compartment has significant OA
See the full criteria
Where Is This Study? (1 UK site)
Nicholas Clement
Edinburgh EH16 6SA, United Kingdom
How to Get in Touch
Nicholas D Clement, MD, PhD
Sponsor contactCONTACT
James T Patton, FRCS
Sponsor contactCONTACT
