RCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee Arthroplasty

Sponsor

University College, London (Other)

Overall Status

Recruiting

CT.gov ID

NCT04095637

Collaborator

Stryker Instruments (Industry)

140

Enrollment

Location

Arms

61.2

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unicompartmental Knee Replacement Osteo Arthritis Knee Surgery	Device: Medial knee arthroplasty	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Prospective Randomised Control Trial of Mako Medial Unicondylar Knee Arthroplasty Versus Jig-based Oxford Unicompartmental Knee Arthroplasty With Navigation Contro

Actual Study Start Date :

Nov 24, 2017

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mako medial UKA Mako medial unicondylar knee arthroplasty	Device: Medial knee arthroplasty Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant
Active Comparator: Oxford media UKA Oxford unicompartmental knee arthroplasty with navigation control	Device: Medial knee arthroplasty Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant

Arm

Intervention/Treatment

Experimental: Mako medial UKA

Mako medial unicondylar knee arthroplasty

Device: Medial knee arthroplasty

Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant

Active Comparator: Oxford media UKA

Oxford unicompartmental knee arthroplasty with navigation control

Device: Medial knee arthroplasty

Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant

Outcome Measures

Primary Outcome Measures

Accuracy of component positioning [6 weeks post-op]
Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan

Secondary Outcome Measures

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
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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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