Osteo Arthritis Knee, Surgery, Unicompartmental Knee Replacement
Conditions
Keywords
alignment, computer navigation, implant position, mako robot, makoplasty, unicondylar knee replacement
Brief summary
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.
Interventions
DEVICEMedial knee arthroplasty
Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant
Sponsors
Stryker Instruments
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* • Patient has medial unicompartmental knee osteoarthritis requiring primary UKA * Patient and Surgeon are in agreement that UKA is the most appropriate treatment * Patient is fit for surgical intervention following review by surgeon and anaesthetist * Patient is between 40-80 years of age at time of surgery * Gender: male and female * Patient must be capable of giving informed consent and agree to comply with the postoperative review program * Patient must be a permanent resident in an area accessible to the study site * Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken
Exclusion criteria
* • Patient is not suitable for primary UKA e.g. multi-compartmental knee osteoarthritis, anterior cruciate ligament rupture * Patient is not medically fit for surgical intervention * Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral UKA * Patient is immobile or has another neurological condition affecting musculoskeletal function * Patient is less than 40 years of age or greater than 80 years of age * Patient is already enrolled on another concurrent clinical trial * Patient is unable or unwilling to sign the informed consent form specific to this study * Patient is unable to attend the follow-up programme * Patient is non-resident in local area or expected to leave the catchment area postoperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of component positioning | 6 weeks post-op | Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower limb alignment | 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. |
| Femoral implant alignment | 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. |
| Tibial implant alignment | 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. |
| Operating time | Intraoperative | Length of time of operation in minutes |
| Time to discharge | 6 weeks post op | Length of hospital admission from admission date to documented discharge from hospital |
| Oxford Knee Score (OKS) | 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 |
| Use of mobility aids | 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 |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 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 |
| Knee injury and Osteoarthritis Outcome Score (KOOS) Osteoarthritis Outcome Score (KOOS) | 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 |
| European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D) | 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 |
| Mobilisation distance (metres) | 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 |
| Range of movement | 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 |
| Complications | 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 |
| Short form SF-12 | 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 |
Countries
United Kingdom
Contacts
Primary ContactJenni Tahmassebi
Outcome results
None listed