RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques

NCT06389435 | Recruiting

• 2 other identifiers: 2024DSKnee
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Arthroplasty, Total; Robotic-assisted; Osteoarthritis of the Knee

Keywords

Knee arthroplasty; Robotic assisted; Osteoartritis

Outcome Measures

Primary Outcomes (1)

• The Forgotten Joint Score (FJS)

  The primary outcome measurement will be the Forgotten Joint Score (FJS), measured at 24 months post-surgery. The FJS evaluates the patient's ability to 'forget' the artificial joint in their daily life. This scale ranges from 0 to 100, where 0 represents the maximum joint awareness and 100 represents complete joint unawareness, indicating that the patient does not perceive the joint during daily activities. Higher scores indicate a better outcome, reflecting the success of the knee replacement surgery in restoring natural joint function such that the joint feels like a natural part of the body.

  24 months post surgery

Secondary Outcomes (6)

• KOOS

  preop, 6 weeks, 12 and 24 months post surgery

• ADLS knee instability

  6 weeks, 12 and 24 months post-operation.

• The Forgotten Joint Score (FJS)

  6 weeks and 12 months post surgery

• EQ-5D

  6 weeks, 12 and 24 months post surgery

• Knee alignment

  6 weeks post surgery

Study Arms (2)

RTKR

EXPERIMENTAL

Robotic assisted total knee replacement (RTKR)

Procedure: Patients will be randomized to undergo TKR or RTKR

TKR

ACTIVE COMPARATOR

Standard total knee replacement (TKR)

Procedure: Patients will be randomized to undergo TKR or RTKR

Interventions

Patients will be randomized to undergo TKR or RTKR PROCEDURE

Total knee replacement (control group)

RTKR; TKR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danderyd Hospital: lead
• Karolinska Institutet: collaborator
• Stockholm South General Hospital: collaborator

Study Sites (1)

Danderyds Sjukhus

Stockholm, 18288, Sweden

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Olof Sköldenberg, MD, PhD

CONTACT

46+700891253; olof.skoldenberg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 29, 2024
• Study Start: March 4, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)