---
title: "RCT: Mako Medial Unicondylar Knee Arthroplasty vs Oxford Unicondylar Knee Arthroplasty"
nct_id: NCT04095637
overall_status: RECRUITING
phase: NA
sponsor: University College, London
study_type: INTERVENTIONAL
primary_condition: Unicompartmental Knee Replacement
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04095637.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04095637"
ct_last_update_post_date: 2025-07-09
last_seen_at: "2026-05-12T06:25:56.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT04095637](https://clinicaltrials.gov/study/NCT04095637)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 140
- **Lead Sponsor:** University College, London
- **Collaborators:** Stryker Instruments
- **Conditions:** Unicompartmental Knee Replacement, Osteo Arthritis Knee, Surgery
- **Start Date:** 2017-11-24
- **Completion Date:** 2026-01-01
- **CT.gov Last Update:** 2025-07-09

## 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

- **Minimum age:** 40 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **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
```

## Arms

- **Mako medial UKA** (EXPERIMENTAL) — Mako medial unicondylar knee arthroplasty
- **Oxford media UKA** (ACTIVE_COMPARATOR) — Oxford unicompartmental knee arthroplasty with navigation control

## Interventions

- **Medial knee arthroplasty** (DEVICE) — Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant

## Primary Outcomes

- **Accuracy of component positioning** _(time frame: 6 weeks post-op)_ — Comparison of accuracy of component positioning as assessed by postoperative low radiation dose CT scan

## Secondary Outcomes

- **Lower limb alignment** _(time frame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op)_
- **Femoral implant alignment** _(time frame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op)_
- **Tibial implant alignment** _(time frame: Pre-op then 6 weeks, 6 months, 1 and 2 years post-op)_
- **Operating time** _(time frame: Intraoperative)_
- **Time to discharge** _(time frame: 6 weeks post op)_
- **Oxford Knee Score (OKS)** _(time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)_
- **Short form SF-12** _(time frame: 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)** _(time frame: 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)** _(time frame: 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)** _(time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)_
- **Mobilisation distance (metres)** _(time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)_
- **Use of mobility aids** _(time frame: Pre-op then 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op)_
- **Range of movement** _(time frame: Pre-op then 6 weeks post-op, 6 months post-op, one year post-op; 2 years post-op)_
- **Complications** _(time frame: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years)_

## Locations (1)

- UCL Hospital NHS Foundation Trust, London, United Kingdom — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ucl hospital nhs foundation trust|london||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04095637.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04095637*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*