RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques

Osteoarthritis of the Knee Clinical Trial

— ROCKETS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06389435
• Other study ID #: 2024DS
• Secondary ID: Knee
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: January 2028

Study information

• Verified date: April 2024
• Source: Danderyd Hospital
• Contact: Olof Sköldenberg, MD, PhD
• Phone: 46+700891253
• Email: olof.skoldenberg[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2028
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty, Total
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Sweden	Danderyds Sjukhus	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Danderyd Hospital	Karolinska Institutet, Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	KOOS	The secondary outcome measure will include the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS is designed to assess patients' opinions about their knee and associated problems. The score comprises five separately scored subscales: Pain, Other Symptoms, Function in Daily Living (ADL), Function in Sport and Recreation (Sport/Rec), and Knee-Related Quality of Life (QOL). Each subscale is scored from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems. Higher scores indicate a better outcome, reflecting fewer symptoms and higher levels of knee function in daily and recreational activities.	preop, 6 weeks, 12 and 24 months post surgery
Secondary	ADLS knee instability	The self reported Activities of Daily Living Scale of the Knee Outcome Survey (ADLS) where participants will rate, over the previous 1-2 days, the degree to which slipping/partial giving way (item 1) and buckling/full giving way (item 2) of each knee affected daily activity graded from 0 (no) to 6 (severe impact on daily living)	6 weeks, 12 and 24 months post-operation.
Secondary	The Forgotten Joint Score (FJS)	A secondary outcome measurement will be the Forgotten Joint Score (FJS), measured preoperatively, and at 6 weeks and 12 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.	6 weeks and 12 months post surgery
Secondary	EQ-5D	A secondary outcome measure will be the European Quality of Life-5 Dimensions (EQ-5D). The EQ-5D is a standardized instrument used to measure health-related quality of life that can be utilized in a wide range of health conditions and treatments. This tool includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels: no problems, some problems, and extreme problems. The EQ-5D index is calculated by applying a formula that attaches values to each of the levels in each dimension. This index can range from -0.594 to 1.0, where 1.0 indicates the best health state, 0 represents death, and negative values represent health states perceived as worse than death.	6 weeks, 12 and 24 months post surgery
Secondary	Knee alignment	Knee alignment measured with long standing x-ray	6 weeks post surgery
Secondary	Adverse events	Adverse events	up to 24 months post surgery