Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05842538

Robotic Assisted Surgery In Total Knee Replacement

Led by Sahlgrenska University Hospital · Updated on 2023-10-10

200

Participants Needed

2

Research Sites

239 weeks

Total Duration

On this page

Sponsors

S

Sahlgrenska University Hospital

Lead Sponsor

S

Stryker Nordic

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to compare robotic arm assisted surgery with manual surgery in patients operated with knee replacement. The main aim of the study is to compare changes in joint awareness (measured by the Forgotten Joint Score. Participants who are listed for knee arthroplasty are randomised to either robotic arm assisted surgery or manual surgery.

CONDITIONS

Official Title

Robotic Assisted Surgery In Total Knee Replacement

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Listed for elective primary total knee replacement for end stage osteoarthritis
  • Suitable candidate for cruciate retaining total knee replacement (Triathlon prosthesis)
  • Male or female aged 18 to 80 years at the time of listing for surgery
  • Able to understand and provide written consent
Not Eligible

You will not qualify if you...

  • Varus deformity greater than 20 degrees as assessed by consultant
  • Unable to comply with the study protocol including refusal of CT scan
  • Female who is pregnant, breastfeeding, or planning pregnancy during the study
  • Requires patella resurfacing
  • Unable to understand patient information, provide consent, or complete questionnaires due to cognitive or language issues
  • Any significant disease or disorder that may pose risk, affect study results, or hinder participation as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Sahlgrenska University hospital

Gothenburg, Sweden

Actively Recruiting

2

Örebro University Hospital, Department of Medical Sciences

Örebro, Sweden, 705 85

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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