Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

Arthroplasties, Knee Replacement Clinical Trial

Official title:

Improved Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06203756
• Other study ID #: CP-2017-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 9, 2017
• Est. completion date: April 2031

Study information

• Verified date: January 2024
• Source: Corin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to learn about the effects of soft tissue balancing technology in patients undergoing robotic assisted total knee arthroplasty (TKA). The main questions it aims to answer are:

• What is the accuracy of soft tissue balancing in both sensor assisted and non-sensor assisted TKA

• What are the outcomes of a cohort of TKA patients who undergo surgery with soft tissue balance technology

Participants will answer health related surveys both before and after their surgery.

Description:

This is a post market multicenter study to determine the effect of the BalanceBot on soft tissue balancing, and the effect of robotic-assisted TKA with the BalanceBot on patient reported outcomes measures (PROMs). PROMs will include knee pain, symptoms, function during activities of daily living, sport and recreation, and quality of life from the KOOS, VR-12 or PROMIS, UCLA activity scale and patient satisfaction.

Secondary objectives are:

• To quantify the frequency and extent of soft tissue releases and bone recuts performed in measured resection (femur first) and gap balancing (tibial first) surgical techniques

• Determine if any associations exist between patient parameters, surgical parameters (including final intra-operative balance achieved) and patient reported outcomes.

Allocation of enrollment is estimated to be 15% standard robotic and 85% BalanceBot. The decision to use the BalanceBot or Standard Robotic will be left to the discretion of the surgical team. The surgeon will use their preferred technique (tibia first or femur first) as per their standard of care.

During the initial phase of the study, standard robotic patients will have their soft tissue balance assessed using the BalanceBot in a blinded fashion. The surgeon will be blinded to these BalanceBot measurements, which will be recorded by an assistant during the case. After this initial phase of the study, the BalanceBot will not be used during standard robotic cases. The BalanceBot will be used to quantify the final ligament balanced achieved in the BalanceBot cases and also in a subset of standard robotic cases. In the standard robotic subset cohort, the surgeon will complete the surgery as they would normally, including performing any ligament balancing using manual blocks or manual implant trial components as per the standard technique. Once the surgeon believes they have sufficiently balanced the knee they will insert the BalanceBot to measure the final balanced achieved. The surgeon will be blinded to the BalanceBot measurements at this stage so as not to bias the surgery. In the BalanceBot cases, the surgeon will have visibility to the onscreen knee balance and force data and can use the data to assist in the ligament balancing process as per the standard BalanceBot technique. The standard robotic subset cohort will be enrolled first followed by the BalanceBot cohort such that the use of the BalanceBot does not bias or otherwise influence the standard robotic procedure.

The decision to use the BalanceBot or Standard Robotic will be left to the discretion of the surgical team. The surgeon will use their preferred technique (tibia first or femur first) as per their standard of care.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 642
• Est. completion date: April 2031
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patient must be a candidate for a primary or revision total knee arthroplasty

2. Patient is able and willing to sign the informed consent and follow study procedures

3. Patient's joint must be anatomically and functionally suited to receive the selected implant and accommodate use of the robotic assistance

Exclusion Criteria:

1. Patient has a BMI >45.

2. Significant neurological or musculoskeletal disorders or disease that may interfere with total knee arthroplasty survival, adversely affect gait or weight bearing, (i.e. Paget's disease, Charcot's disease, muscular dystrophy, multiple sclerosis).

3. The presence of highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, HIV, etc.).

4. Presence of known active metastatic or neoplastic disease.

5. Cancer patients unless they have received curative treatment and have no evidence of recurrence for 5 years.

6. Patient has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease).

7. Patient has an active infection or joint sepsis.

8. Patient has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints).

9. Patients with allergies or suspected sensitivity to any patient-contacting component of the implant to be used in the study Has known sensitivity to implants or the materials in the device including but not limited to: Ti, Al, V, Co, Cr, Mo, Ni and Si3N4.).

10. Patients who are currently on medical leave from their employment due to Worker's Compensation.

11. Patients who are at high risk for poor healing or confounding outcomes or at excessive risk for surgery (e.g., clinically significant/being actively treated for renal, hepatic, cardiac, hematologic, or neurologic disease or poorly controlled diabetes (HbA1c > 8 mg/dL) or previous history of joint infection).

12. Patients who are known drug or alcohol abusers or with psychological disorders as defined by DSM V that could affect follow-up care or treatment outcomes.

13. Patients who are currently involved in another clinical study with an investigational device.

14. Patients with current litigation pending related to medical treatment of any sort.

15. Patients, who, in the opinion of the investigator, will not be able to complete the study per the protocol.

Related Conditions & MeSH terms

• Arthroplasties, Knee Replacement

Intervention

Device:
• Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC
Robotic-assisted total knee arthroplasty in femur and tibial first workflows using the BalanceBot to characterize soft tissue balance, and the Apex UltraCongruent (UC) knee implant type
• Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS
Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex PosteriorStabilized (PS) knee implant type
• Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision
Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex Revision knee implant type

Locations

Country	Name	City	State
United States	Flagstaff Bone and Joint	Flagstaff	Arizona
United States	Nyu Langone-Long Island	Garden City	New York
United States	Gundersen Health System	La Crosse	Wisconsin
United States	Orthopaedics New England	Middlebury	Connecticut
United States	Oklahoma Sports and Orthopedics Institute	Oklahoma City	Oklahoma
United States	DeClaire LaMacchia Orthopaedic Institute	Rochester	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Corin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of BalanceBot on achieving final intra-operative joint balance within 2 mm	Different arms of the study use the BalanceBot in different ways. The final intra-operative joint balance is measured in each arm. Difference in the proportion of knees with mediolateral balance within 2mm will be compared.	Intraoperative
Primary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Post-operative patient outcomes (Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores) are to be captured and compared to pre-operative outcomes.; KOOS ranges from 0 - 100, in which 100 is best.	2 Years
Primary	Frequency of Adverse Events	Frequency of device and implant related adverse events are to be recorded.	10 Years
Secondary	Frequency of soft tissue release	Quantify the frequency of soft tissue releases performed in measured resection (femur first) and gap balancing (tibial first) surgical techniques	Intraoperative
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores between knees which received a soft tissue release and those which did not.; KOOS ranges from 0 - 100, in which 100 is best.	3 Months
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative University of California at Los Angeles Activity (UCLA) scores between knees which received a soft tissue release and those which did not.; UCLA ranges from 1 - 10, in which 10 is best.	3 Months
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health scores between knees which received a soft tissue release and those which did not.; PROMIS-10 ranges from 1 - 67, in which 67 is best.	3 Months
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores between knees which received a soft tissue release and those which did not.; KOOS ranges from 0 - 100, in which 100 is best.	6 Months
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative University of California at Los Angeles Activity (UCLA) scores between knees which received a soft tissue release and those which did not.; UCLA ranges from 1 - 10, in which 10 is best.	6 Months
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health scores between knees which received a soft tissue release and those which did not.; PROMIS-10 ranges from 1 - 67, in which 67 is best.	6 Months
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores between knees which received a soft tissue release and those which did not.; KOOS ranges from 0 - 100, in which 100 is best.	1 Year
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative University of California at Los Angeles Activity (UCLA) scores between knees which received a soft tissue release and those which did not.; UCLA ranges from 1 - 10, in which 10 is best.	1 Year
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health scores between knees which received a soft tissue release and those which did not.; PROMIS-10 ranges from 1 - 67, in which 67 is best.	1 Year
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores between knees which received a soft tissue release and those which did not.; KOOS ranges from 0 - 100, in which 100 is best.	2 Years
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative University of California at Los Angeles Activity (UCLA) scores between knees which received a soft tissue release and those which did not.; UCLA ranges from 1 - 10, in which 10 is best.	2 Years
Secondary	Impact of soft tissue release on outcome	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health scores between knees which received a soft tissue release and those which did not.; PROMIS-10 ranges from 1 - 67, in which 67 is best.	2 Years
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores between knees which received a soft tissue release and those which did not.; KOOS ranges from 0 - 100, in which 100 is best.	3 Months
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative University of California at Los Angeles Activity (UCLA) scores between knees which received a soft tissue release and those which did not.; UCLA ranges from 1 - 10, in which 10 is best.	3 Months
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health scores between knees which received a soft tissue release and those which did not.; PROMIS-10 ranges from 1 - 67, in which 67 is best.	3 Months
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores between knees which received a soft tissue release and those which did not.; KOOS ranges from 0 - 100, in which 100 is best.	6 Months
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative University of California at Los Angeles Activity (UCLA) scores between knees which received a soft tissue release and those which did not.; UCLA ranges from 1 - 10, in which 10 is best.	6 Months
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health scores between knees which received a soft tissue release and those which did not.; PROMIS-10 ranges from 1 - 67, in which 67 is best.	6 Months
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores between knees which received a soft tissue release and those which did not.; KOOS ranges from 0 - 100, in which 100 is best.	1 Year
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative University of California at Los Angeles Activity (UCLA) scores between knees which received a soft tissue release and those which did not.; UCLA ranges from 1 - 10, in which 10 is best.	1 Year
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health scores between knees which received a soft tissue release and those which did not.; PROMIS-10 ranges from 1 - 67, in which 67 is best.	1 Year
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores between knees which received a soft tissue release and those which did not.; KOOS ranges from 0 - 100, in which 100 is best.	5 years
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative University of California at Los Angeles Activity (UCLA) scores between knees which received a soft tissue release and those which did not.; UCLA ranges from 1 - 10, in which 10 is best.	5 years
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health scores between knees which received a soft tissue release and those which did not.; PROMIS-10 ranges from 1 - 67, in which 67 is best.	5 years
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores between knees which received a soft tissue release and those which did not.; KOOS ranges from 0 - 100, in which 100 is best.	10 Years
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative University of California at Los Angeles Activity (UCLA) scores between knees which received a soft tissue release and those which did not.; UCLA ranges from 1 - 10, in which 10 is best.	10 Years
Secondary	Effect of BalanceBot on patient reported outcome measures (PROMs)	Evaluate impact of soft tissue release on patient outcomes by comparing post-operative Patient-Reported Outcomes Measurement Information System (PROMIS) 10 Global Health scores between knees which received a soft tissue release and those which did not.; PROMIS-10 ranges from 1 - 67, in which 67 is best.	10 Years