Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stryker Instruments | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mako medial UKA | Experimental | Mako medial unicondylar knee arthroplasty |
|
| Oxford media UKA | Active Comparator | Oxford unicompartmental knee arthroplasty with navigation control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medial knee arthroplasty | Device | Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of component positioning | Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan | 6 weeks post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Lower limb alignment | Lower limb alignment in the coronal, axial, and sagittal planes as assessed by postoperative low radiation dose CT scan at 6 weeks after surgery. | Pre-op then 6 weeks, 6 months, 1 and 2 years post-op |
| Femoral implant alignment |
Not provided
Inclusion Criteria:
• Patient has medial unicompartmental knee osteoarthritis requiring primary UKA
Exclusion Criteria:
• Patient is not suitable for primary UKA e.g. multi-compartmental knee osteoarthritis, anterior cruciate ligament rupture
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenni Tahmassebi | Contact | 02034479413 | jenni.tahmassebi1@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Fares S Haddad | UCL Hospitals NHS Foundation Trust | Study Chair |
| Babar Kayani | UCL Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCL Hospital NHS Foundation Trust | Recruiting | London | NW1 2BU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32807219 | Derived | Kayani B, Konan S, Tahmassebi J, Ayuob A, Moriarty PD, Haddad FS. Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based unicompartmental knee arthroplasty with navigation control: study protocol for a prospective randomised controlled trial. Trials. 2020 Aug 17;21(1):721. doi: 10.1186/s13063-020-04631-5. |
Not provided
Not provided
No plan to share IPD
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Femoral implant alignment in the coronal, axial, and sagittal planes as assessed by postoperative low radiation dose CT scan at 6 weeks after surgery.
| Pre-op then 6 weeks, 6 months, 1 and 2 years post-op |
| Tibial implant alignment | Tibial implant alignment in the coronal, axial, and sagittal planes as assessed by postoperative low radiation dose CT scan at 6 weeks after surgery. | Pre-op then 6 weeks, 6 months, 1 and 2 years post-op |
| Operating time | Length of time of operation in minutes | Intraoperative |
| Time to discharge | Length of hospital admission from admission date to documented discharge from hospital | 6 weeks post op |
| Oxford Knee Score (OKS) | Patient recorded outcome measure via questionnaire; cumulative score with best being 48, worst being 0 | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Short form SF-12 | 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 | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Patient recorded outcome measure via questionnaire; cumulative score with 0 being best score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Knee injury and Osteoarthritis Outcome Score (KOOS) Osteoarthritis Outcome Score (KOOS) | Patient recorded outcome measure via questionnaire; 6 domains contribute to overall percentage; 100% being best score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D) | Health-related quality of life via 5 domains; score -1 to 1 with 1 being best score | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Mobilisation distance (metres) | How far patient can walk in metres | Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Use of mobility aids | Documenting the use of any mobility aid to assist with ambulation; can include wheelchair, walker, crutches, sticks or no aid required | Pre-op then 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op |
| Range of movement | Range of movement of knee joint in degrees, typically from 0 to 140 degrees; higher number is better score | Pre-op then 6 weeks post-op, 6 months post-op, one year post-op; 2 years post-op |
| Complications | 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 | during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years |