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Recruiting NCT06389435

RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques

No phase Interventional Knee Arthroplasty, Total Robotic-assisted Osteoarthritis of the Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patients will be randomized to undergo TKR or RTKR.
Who it may be relevant to
Registry conditions: Knee Arthroplasty, Total, Robotic-assisted, Osteoarthritis of the Knee. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ROCKETS: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques in a Randomized, Multicenter, Preference-tolerant Study

Overview

Rationale for conducting the study: The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events. Study design: Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques. Study population: Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study. Number of patients: 400 Inclusion criteria: Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study. Exclusion criteria: Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons. Primary outcome variables: The Forgotten Joint Score (FJS) at 2 years after surgery

Interventions

  • Procedure Patients will be randomized to undergo TKR or RTKR
    Total knee replacement (control group)

Primary outcome measures

  • The Forgotten Joint Score (FJS) [Time frame: 24 months post surgery]
Secondary outcome measures (6)
  • KOOS [Time frame: preop, 6 weeks, 12 and 24 months post surgery]
  • ADLS knee instability [Time frame: 6 weeks, 12 and 24 months post-operation.]
  • The Forgotten Joint Score (FJS) [Time frame: 6 weeks and 12 months post surgery]
  • EQ-5D [Time frame: 6 weeks, 12 and 24 months post surgery]
  • Knee alignment [Time frame: 6 weeks post surgery]
  • Adverse events [Time frame: up to 24 months post surgery]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 years and older.
  • Eligible for TKR according to local guidelines and routines.
  • Willingness to participate in the study.

Exclusion criteria

  • Patients with extreme malalignment necessitating special implants or techniques.
  • Patients unfit for surgery due to other medical reasons.
  • Patients who, for other reason such as alcohol or substance abuse, is deemed unsuitable to participate in the study.
  • Patients who, for other reasons can't fulfill the required patient recorded outcome measures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Danderyds Sjukhus — Stockholm

Identifiers

NCT: NCT06389435 · 2024DS · Knee

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗