Trial Outcomes & Findings for A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes (NCT NCT03523897)
NCT ID: NCT03523897
Last Updated: 2025-06-06
Results Overview
The FJS is a self-completed 12-item questionnaire used to assess patients' awareness of their artificial joint during activities of daily living on an awareness scale of 0 (never) to 4 (mostly)
TERMINATED
NA
92 participants
1 year
2025-06-06
Participant Flow
Participant milestones
| Measure |
Robot Assisted Total Knee Replacement
In addition to expert judgment and hand-eye coordination, the surgeon also relies on a robot in making cuts within the pre-determined diseased areas of the joints and placing the implants. This is made possible by uploading 3-dimensional (3D) images of the knee joints into the robot prior to surgery. The robot uses these 3D images to guide the surgeon during the procedure. The 3D images are obtained from a computerized tomography (CT) scan that combines a series of X-ray images taken from different angles to create cross-sectional images of the bones.
Robot Assisted Total Knee Replacement: A robotic-assisted surgical procedure to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
|
Traditional Total Knee Replacement
The traditional method where the surgeon employs mechanical guides, expert judgment, and natural hand-eye coordination in making the necessary cuts to prepare the bone for the implant as well as in placing the implant.
Traditional Total Knee Replacement: A surgical procedure using mechanical guides to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
53
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
39
|
53
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective Study to Evaluate Robot Assisted Total Knee Replacement Outcomes
Baseline characteristics by cohort
| Measure |
Robot Assisted Total Knee Replacement
n=39 Participants
In addition to expert judgment and hand-eye coordination, the surgeon also relies on a robot in making cuts within the pre-determined diseased areas of the joints and placing the implants. This is made possible by uploading 3-dimensional (3D) images of the knee joints into the robot prior to surgery. The robot uses these 3D images to guide the surgeon during the procedure. The 3D images are obtained from a computerized tomography (CT) scan that combines a series of X-ray images taken from different angles to create cross-sectional images of the bones.
Robot Assisted Total Knee Replacement: A robotic-assisted surgical procedure to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
|
Traditional Total Knee Replacement
n=53 Participants
The traditional method where the surgeon employs mechanical guides, expert judgment, and natural hand-eye coordination in making the necessary cuts to prepare the bone for the implant as well as in placing the implant.
Traditional Total Knee Replacement: A surgical procedure using mechanical guides to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
53 participants
n=7 Participants
|
92 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Study canceled due to lack of resources. The personnel responsible for collecting data left the hospital system before any data was collected and the investigators involved did not have the time necessary to collect and organize data. Therefore, no data was collected at the 1-year timeframe, leading to no data available for analysis.
The FJS is a self-completed 12-item questionnaire used to assess patients' awareness of their artificial joint during activities of daily living on an awareness scale of 0 (never) to 4 (mostly)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Study canceled due to lack of resources. The personnel responsible for collecting data left the hospital system before any data was collected and the investigators involved did not have the time necessary to collect and organize data. Therefore, no data was collected at the 1-year timeframe, leading to no data available for analysis.
The KOOS is a knee-specific instrument used to evaluate short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 42 questions in 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearThe VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeks postoperativelyThe mechanical alignment of the entire post-operative limb will be measured at 6 weeks by long-limb radiograph cassettes and compared to the pre-operative plan for accuracy and deviation less than or greater than 3 degrees from the intended target. From each treatment group, the percentage of patients with radiographic outliers (deviation greater that 3 degrees from the expected implant placement) will be compared.
Outcome measures
Outcome data not reported
Adverse Events
Robot Assisted Total Knee Replacement
Traditional Total Knee Replacement
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place