Back to resultsRCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee Arthroplasty
Primary Purpose
Unicompartmental Knee Replacement, Osteo Arthritis Knee, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Medial knee arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Unicompartmental Knee Replacement focused on measuring alignment, computer navigation, implant position, mako robot, makoplasty, unicondylar knee replacement
Eligibility Criteria
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
Sites / Locations
- UCL Hospital NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mako medial UKA
Oxford media UKA
Arm Description
Mako medial unicondylar knee arthroplasty
Oxford unicompartmental knee arthroplasty with navigation control
Outcomes
Primary Outcome Measures
Accuracy of component positioning
Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan
Secondary Outcome Measures
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.
Femoral implant alignment
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
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
Length of time of operation in minutes
Time to discharge
Length of hospital admission from admission date to documented discharge from hospital
Oxford Knee Score (OKS)
Patient recorded outcome measure via questionnaire; cumulative score with best being 48, worst being 0
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
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Patient recorded outcome measure via questionnaire; cumulative score with 0 being best score
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
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
Mobilisation distance (metres)
How far patient can walk in metres
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
Range of movement
Range of movement of knee joint in degrees, typically from 0 to 140 degrees; higher number is better score
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
Full Information
NCT ID
NCT04095637
First Posted
July 17, 2019
Last Updated
June 27, 2023
Sponsor
University College, London
Collaborators
Stryker Instruments
1. Study Identification
Unique Protocol Identification Number
NCT04095637
Brief Title
RCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee Arthroplasty
Official Title
A Prospective Randomised Control Trial of Mako Medial Unicondylar Knee Arthroplasty Versus Jig-based Oxford Unicompartmental Knee Arthroplasty With Navigation Contro
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Stryker Instruments
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unicompartmental Knee Replacement, Osteo Arthritis Knee, Surgery
Keywords
alignment, computer navigation, implant position, mako robot, makoplasty, unicondylar knee replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mako medial UKA
Arm Type
Experimental
Arm Description
Mako medial unicondylar knee arthroplasty
Arm Title
Oxford media UKA
Arm Type
Active Comparator
Arm Description
Oxford unicompartmental knee arthroplasty with navigation control
Intervention Type
Device
Intervention Name(s)
Medial knee arthroplasty
Intervention Description
Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant
Primary Outcome Measure Information:
Title
Accuracy of component positioning
Description
Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan
Time Frame
6 weeks post-op
Secondary Outcome Measure Information:
Title
Lower limb alignment
Description
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
Title
Femoral implant alignment
Description
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
Title
Tibial implant alignment
Description
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
Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
Title
Operating time
Description
Length of time of operation in minutes
Time Frame
Intraoperative
Title
Time to discharge
Description
Length of hospital admission from admission date to documented discharge from hospital
Time Frame
6 weeks post op
Title
Oxford Knee Score (OKS)
Description
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
Title
Short form SF-12
Description
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
Title
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) Osteoarthritis Outcome Score (KOOS)
Description
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
Title
European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)
Description
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
Title
Mobilisation distance (metres)
Description
How far patient can walk in metres
Time Frame
Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Title
Use of mobility aids
Description
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; 1 year post-op; 2 years post-op
Title
Range of movement
Description
Range of movement of knee joint in degrees, typically from 0 to 140 degrees; higher number is better score
Time Frame
Pre-op then 6 weeks post-op, 6 months post-op, one year post-op; 2 years post-op
Title
Complications
Description
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
Time Frame
during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenni Tahmassebi
Phone
02034479413
Email
jenni.tahmassebi1@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fares S Haddad
Organizational Affiliation
UCL Hospitals NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Babar Kayani
Organizational Affiliation
UCL Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCL Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenni Tahmassebi
Phone
02034479413
Email
jenni.tahmassebi1@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD
Citations:
PubMed Identifier
32807219
Citation
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.
Results Reference
derived
Learn more about this trial
RCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee Arthroplasty
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