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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04095637
• Other study ID #: 16/0773
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: University College, London
• Contact: Jenni Tahmassebi
• Phone: 02034479413
• Email: jenni.tahmassebi1[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Surgery
• Unicompartmental Knee Replacement

Intervention

Device:
• Medial knee arthroplasty
Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant

Locations

Country	Name	City	State
United Kingdom	UCL Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Stryker Instruments

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of component positioning	Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan	6 weeks post-op
Secondary	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
Secondary	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.	Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
Secondary	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
Secondary	Operating time	Length of time of operation in minutes	Intraoperative
Secondary	Time to discharge	Length of hospital admission from admission date to documented discharge from hospital	6 weeks post op
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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