UCL Hospital NHS Foundation Trust
London, NW1 2BU, United Kingdom
Location status: Recruiting
NCT Number: NCT04095637
The overall aim of this prospective, randomised, single-blinded, controlled trial is to compare clinical outcomes and accuracy of implant positioning in Mako robotic UKA versus jig-based Oxford UKA with navigation control. Patients receiving the Mako robotic UKA (Stryker Ltd) will form the investigation group and those undergoing the jig-based Oxford UKA (Zimmer-Biomet Ltd) with navigation control will form the control group.
The primary objective in this study is to compare accuracy of component positioning as assessed by postoperative low radiation dose CT scan between conventional Jig-based Oxford UKA with navigation control and Mako robotic UKA.
Interested in participating?
Request Info40 year–80 year
All sexes
Interventional
Not applicable
London, NW1 2BU, United Kingdom
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant
Time frame: 6 weeks post-op
Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan
Time frame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
Lower limb alignment in the coronal, axial, and sagittal planes as assessed by postoperative low radiation dose CT scan at 6 weeks after surgery.
Time frame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
Femoral implant alignment in the coronal, axial, and sagittal planes as assessed by postoperative low radiation dose CT scan at 6 weeks after surgery.
Time frame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
Tibial implant alignment in the coronal, axial, and sagittal planes as assessed by postoperative low radiation dose CT scan at 6 weeks after surgery.
Time frame: Intraoperative
Length of time of operation in minutes
Time frame: 6 weeks post op
Length of hospital admission from admission date to documented discharge from hospital
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Patient recorded outcome measure via questionnaire; cumulative score with best being 48, worst being 0
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Patient recorded outcome measure via questionnaire; cumulative score via 12 questions pertaining to perception of current physical and mental health; higher score best score, lower score worse score
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Patient recorded outcome measure via questionnaire; cumulative score with 0 being best score
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Patient recorded outcome measure via questionnaire; 6 domains contribute to overall percentage; 100% being best score
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Health-related quality of life via 5 domains; score -1 to 1 with 1 being best score
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
How far patient can walk in metres
Time frame: Pre-op then 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Documenting the use of any mobility aid to assist with ambulation; can include wheelchair, walker, crutches, sticks or no aid required
Time frame: Pre-op then 6 weeks post-op, 6 months post-op, one year post-op; 2 years post-op
Range of movement of knee joint in degrees, typically from 0 to 140 degrees; higher number is better score
Time frame: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
Complications as relating to surgery; to include pain; fracture; neurovascular injury; blood clots; infection of wound; infection of artificial joint; pain; heart attack; stroke; pulmonary embolus; return to operating theatre; revision surgery; death
Contact information is provided by the study sponsor or research team.
University College, London
Other
A Prospective Randomised Control Trial of Mako Medial Unicondylar Knee Arthroplasty Versus Jig-based Oxford Unicompartmental Knee Arthroplasty With Navigation Contro
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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