NCT06036212

Study to Evaluate Patient Outcomes and Safety and Effectiveness of Robotic Assisted Unicompartmental Knee Replacements Versus Conventional Unicompartmental Knee for Subjects With Primary Arthritis of the Knee Joint Involving One (UKA) Compartment (Medial or Lateral)

A Prospective, Single-blind, Multi-Centre, Randomised Controlled Study to Evaluate the Clinical and Patient Reported Outcomes Following Unicompartmental Knee Arthroplasty With a Robotic Assisted Technique

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of this trial is to compare functional and patient-reported outcomes and to assess the safety and effectiveness and long-term performance of the Smith+Nephew Robotic Systems for Unicompartmental Knee Replacements to non-robotic, conventionally implanted Unicompartmental Knee Replacements.

Detailed description

There are two phases for this study: * Phase 1: The primary objective of this study is to compare Forgotten Joint Score (FJS) 12-month patient reported outcome scores, in patients undergoing robotic assisted Unicompartmental Knee Replacements as compared to those undergoing conventionally implanted Unicompartmental Knee Replacements * Phase 2: The primary objective of Phase 2 of this study is evaluate the revisions rates of the JII UK unicompartmental knee at 10 years Research participants / locations: 280 research participants will be recruited from up to 15 sites in the UK, US and Europe. There will be 140 participants undergoing robotic assisted Unicompartmental Knee Replacements and 140 participants undergoing non-robotic, conventionally implanted Unicompartmental Knee Replacements.

Conditions

• Arthroplasty, Replacement, Knee
• Unicompartmental Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	Robotic System	Robotic assisted Unicompartmental Knee replacement (UKA)
DEVICE	Conventional	Unicompartmental Knee Arthroplasty (UKA) with conventional approach and conventional manual instrumentation

Timeline

• Start date: 2023-11-21
• Primary completion: 2027-03-15
• Completion: 2036-03-15
• First posted: 2023-09-13
• Last updated: 2025-11-17

Locations

5 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated device study