Clinical trial NCT04095637: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Unicompartmental Knee Replacement
Osteo Arthritis Knee
Surgery
Keywords: alignment
computer navigation
implant position
mako robot
makoplasty
unicondylar knee replacement
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Stryker Instruments
First posted: 2019-09-19
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Accuracy of component positioning
timeFrame: 6 weeks post-op
Secondary outcomes:
measure: Lower limb alignment
timeFrame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
measure: Femoral implant alignment
timeFrame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
measure: Tibial implant alignment
timeFrame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
measure: Operating time
timeFrame: Intraoperative
measure: Time to discharge
timeFrame: 6 weeks post op
measure: Oxford Knee Score (OKS)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Short form SF-12
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Osteoarthritis Outcome Score (KOOS)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Mobilisation distance (metres)
timeFrame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Use of mobility aids
timeFrame: Pre-op then 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Range of movement
timeFrame: Pre-op then 6 weeks post-op, 6 months post-op, one year post-op; 2 years post-op
measure: Complications
timeFrame: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCL Hospital NHS Foundation Trust
Study officials:
affiliation: UCL Hospitals NHS Foundation Trust
name: Fares S Haddad
role: STUDY_CHAIR
affiliation: UCL Hospitals NHS Foundation Trust
name: Babar Kayani
role: PRINCIPAL_INVESTIGATOR
References:
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.