Unicompartmental Knee ReplacementNCT04095637
RCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee Arthroplasty
A study testing Medial knee arthroplasty in people with Unicompartmental Knee Replacement and Osteo Arthritis Knee, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Unicompartmental Knee Replacement, Osteo Arthritis Knee, Surgery
- What is being tested?
- Medial knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Nov 2017to 1 Jan 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
UCL Hospital NHS Foundation Trust
London, NW1 2BU
Jenni Tahmassebi, 02034479413, jenni.tahmassebi1@nhs.net
About this study
Official title: A Prospective Randomised Control Trial of Mako Medial Unicondylar Knee Arthroplasty Versus Jig-based Oxford Unicompartmental Knee Arthroplasty With Navigation Contro
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.
- Being tested
- Medial knee arthroplasty
- Keywords
- alignment, computer navigation, implant position, mako robot, makoplasty, unicondylar knee replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial knee arthroplastyDevice
Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant
| Study group | Role | What they receive |
|---|---|---|
| Mako medial UKA | Experimental | Mako medial unicondylar knee arthroplasty Receives: Device: Medial knee arthroplasty |
| Oxford media UKA | Active comparator | Oxford unicompartmental knee arthroplasty with navigation control Receives: Device: Medial knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of component positioning
Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan
Measured: 6 weeks post-op
Secondary outcomes (14)
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.
Measured: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
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.
Measured: 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.
Measured: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op
Operating time
Length of time of operation in minutes
Measured: Intraoperative
Time to discharge
Length of hospital admission from admission date to documented discharge from hospital
Measured: 6 weeks post op
Oxford Knee Score (OKS)
Patient recorded outcome measure via questionnaire; cumulative score with best being 48, worst being 0
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start24 Nov 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unicompartmental Knee ReplacementStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Instruments
- Responsible party
- Sponsor
- Investigators
- Fares S Haddad, Study chair, UCL Hospitals NHS Foundation TrustBabar Kayani, Principal investigator, UCL Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095637
- Sponsor's protocol ID
- 16/0773
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2019
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD
Publications
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.
PubMed 32807219