Trial Outcomes & Findings for Survivorship and Outcomes of Robot Assisted Medial Partial Knee Replacement (NCT NCT01845597)

NCT ID: NCT01845597

Last Updated: 2023-07-13

Results Overview

Survivorship of components is defined as knee implant device(s) remaining in patient.

• Recruitment status: COMPLETED
• Target enrollment: 145 participants
• Primary outcome timeframe: 10 years after surgery
• Results posted on: 2023-07-13

Participant Flow

Participants were recruited from 179 subjects who received a robotically guided medial unicompartmental knee arthroplasty (UKA) by the investigating surgeon and were at least 2 years post-operation as of December 30, 2011. Of the 179 subjects contacted by post card and/or a phone call 145 agreed to participate in the study.

Participant milestones

Measure	Robot Assisted Medial Partial Knee Replacement Patients knees that have received a robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. MAKOplasty® medial UKA: A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.
Overall Study STARTED	145
Overall Study 5 Year Survivorship	134
Overall Study COMPLETED	115
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Measure	Robot Assisted Medial Partial Knee Replacement Patients knees that have received a robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. MAKOplasty® medial UKA: A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.
Overall Study Death	8
Overall Study Lost to Follow-up	22

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Robot Assisted Medial Partial Knee Replacement n=145 Participants Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. MAKOplasty® medial UKA: A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.
Age, Categorical <=18 years	0 Participants n=145 Participants
Age, Categorical Between 18 and 65 years	74 Participants n=145 Participants
Age, Categorical >=65 years	71 Participants n=145 Participants
Age, Continuous	64.98 years STANDARD_DEVIATION 8.67 • n=145 Participants
Sex: Female, Male Female	65 Participants n=145 Participants
Sex: Female, Male Male	80 Participants n=145 Participants
Region of Enrollment United States	145 Participants n=145 Participants

PRIMARY outcome

Timeframe: 10 years after surgery

Survivorship of components is defined as knee implant device(s) remaining in patient.

Outcome measures

Measure	MAKOplasty® Medial UKA n=115 Participants Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. MAKOplasty® medial UKA: A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.
10 Year Survivorship of Components	110 Participants

SECONDARY outcome

Timeframe: 5 years after surgery

Survivorship of components is defined as knee implant device(s) remaining in patient.

Outcome measures

Measure	MAKOplasty® Medial UKA n=134 Participants Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. MAKOplasty® medial UKA: A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.
5 Year Survivorship of Components	132 Participants

SECONDARY outcome

Timeframe: 2 years after surgery

Survivorship of components is defined as knee implant device(s) remaining in patient.

Outcome measures

Measure	MAKOplasty® Medial UKA n=145 Participants Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. MAKOplasty® medial UKA: A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.
2 Year Survivorship of Components	144 Participants

Adverse Events

MAKOplasty® Medial UKA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pamela Fairchild

Rebound Research and Education Foundation.

Phone: 3604498728

Email: pfairchild@reboundmd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place