Trial Outcomes & Findings for ROSA Robot Used in Total Knee Replacement Post Market Study (NCT NCT03969654)

Last Updated: 2024-05-03

Results Overview

EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score.

Recruitment status

COMPLETED

Study phase

Target enrollment

181 participants

Primary outcome timeframe

Pre-op (Baseline), 6 weeks, 3 months, and 1 year

Results posted on

2024-05-03

Participant Flow

A maximum of 300 subjects are to be competitively enrolled in this study across all sites; a maximum of 10 U.S sites will contribute, with participating sites each enrolling up to 75 implanted knees. Sites will enroll up to 45 patients using The ROSA Knee System and up to 30 patients using Conventional instrumentation using a consecutive and concurrent approach; total study enrollment into these arms is not to exceed 180 subjects and 120 subjects respectively.

Unit of analysis: Knees

Participant milestones

Participant milestones
Measure	Robotic Assisted TKA Robotic Assisted TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty	Conventional TKA Conventional TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty
Overall Study STARTED	133 133	48 48
Overall Study COMPLETED	133 133	48 48
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Kellgren-Lawrence grade was determined by a Principal Investigator review of the preop knee images for a baseline measurement. A Kellgren-Lawrence grading scale score of greater than or equal to, or less than 3 was used to determine the severity of the units; a score of 3 indicates multiple osteophytes, definite joint space narrowing, sclerosis, and possibly bone deformity. (Kellgren-Lawrence score scale: 0 being no joint space narrowing to 4 being severe joint space narrowing)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robotic Assisted TKA n=133 Knees Robotic Assisted TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty	Conventional TKA n=48 Knees Conventional TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty	Total n=181 Knees Total of all reporting groups
Age, Categorical <=18 years	0 Knees n=133 Knees	0 Knees n=48 Knees	0 Knees n=181 Knees
Age, Categorical Between 18 and 65 years	41 Knees n=133 Knees	15 Knees n=48 Knees	56 Knees n=181 Knees
Age, Categorical >=65 years	92 Knees n=133 Knees	33 Knees n=48 Knees	125 Knees n=181 Knees
Sex: Female, Male Female	74 Knees n=133 Knees	28 Knees n=48 Knees	102 Knees n=181 Knees
Sex: Female, Male Male	59 Knees n=133 Knees	20 Knees n=48 Knees	79 Knees n=181 Knees
Ethnicity (NIH/OMB) Hispanic or Latino	1 Knees n=133 Knees	1 Knees n=48 Knees	2 Knees n=181 Knees
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Knees n=133 Knees	47 Knees n=48 Knees	179 Knees n=181 Knees
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Knees n=133 Knees	0 Knees n=48 Knees	0 Knees n=181 Knees
Kellgren Lawrence KL Grade ≥ 3 No	29 Knees n=128 Knees • The Kellgren-Lawrence grade was determined by a Principal Investigator review of the preop knee images for a baseline measurement. A Kellgren-Lawrence grading scale score of greater than or equal to, or less than 3 was used to determine the severity of the units; a score of 3 indicates multiple osteophytes, definite joint space narrowing, sclerosis, and possibly bone deformity. (Kellgren-Lawrence score scale: 0 being no joint space narrowing to 4 being severe joint space narrowing)	10 Knees n=46 Knees • The Kellgren-Lawrence grade was determined by a Principal Investigator review of the preop knee images for a baseline measurement. A Kellgren-Lawrence grading scale score of greater than or equal to, or less than 3 was used to determine the severity of the units; a score of 3 indicates multiple osteophytes, definite joint space narrowing, sclerosis, and possibly bone deformity. (Kellgren-Lawrence score scale: 0 being no joint space narrowing to 4 being severe joint space narrowing)	39 Knees n=174 Knees • The Kellgren-Lawrence grade was determined by a Principal Investigator review of the preop knee images for a baseline measurement. A Kellgren-Lawrence grading scale score of greater than or equal to, or less than 3 was used to determine the severity of the units; a score of 3 indicates multiple osteophytes, definite joint space narrowing, sclerosis, and possibly bone deformity. (Kellgren-Lawrence score scale: 0 being no joint space narrowing to 4 being severe joint space narrowing)
Kellgren Lawrence KL Grade ≥ 3 Yes	99 Knees n=128 Knees • The Kellgren-Lawrence grade was determined by a Principal Investigator review of the preop knee images for a baseline measurement. A Kellgren-Lawrence grading scale score of greater than or equal to, or less than 3 was used to determine the severity of the units; a score of 3 indicates multiple osteophytes, definite joint space narrowing, sclerosis, and possibly bone deformity. (Kellgren-Lawrence score scale: 0 being no joint space narrowing to 4 being severe joint space narrowing)	36 Knees n=46 Knees • The Kellgren-Lawrence grade was determined by a Principal Investigator review of the preop knee images for a baseline measurement. A Kellgren-Lawrence grading scale score of greater than or equal to, or less than 3 was used to determine the severity of the units; a score of 3 indicates multiple osteophytes, definite joint space narrowing, sclerosis, and possibly bone deformity. (Kellgren-Lawrence score scale: 0 being no joint space narrowing to 4 being severe joint space narrowing)	135 Knees n=174 Knees • The Kellgren-Lawrence grade was determined by a Principal Investigator review of the preop knee images for a baseline measurement. A Kellgren-Lawrence grading scale score of greater than or equal to, or less than 3 was used to determine the severity of the units; a score of 3 indicates multiple osteophytes, definite joint space narrowing, sclerosis, and possibly bone deformity. (Kellgren-Lawrence score scale: 0 being no joint space narrowing to 4 being severe joint space narrowing)

PRIMARY outcome

Timeframe: Pre-op (Baseline), 6 weeks, 3 months, and 1 year

Population: Only subjects with valid EQ5D scores at the follow-up time points are included in the analysis.

Outcome measures

Outcome measures
Measure	Robotic Assisted TKA n=133 Knee Robotic Assisted TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty	Conventional TKA n=48 Knee Conventional TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty
Clinical Performance Preop	.540 score on a scale Standard Deviation .268	.442 score on a scale Standard Deviation .256
Clinical Performance 6 Week	.740 score on a scale Standard Deviation .166	.763 score on a scale Standard Deviation .179
Clinical Performance 3 Month	.826 score on a scale Standard Deviation .137	.842 score on a scale Standard Deviation .128
Clinical Performance 1 Year	.889 score on a scale Standard Deviation .145	.891 score on a scale Standard Deviation .137

PRIMARY outcome

Timeframe: Pre-op (Baseline), 6 weeks, 3 months, and 1 year

Population: Only subjects with valid Oxford scores at the follow-up time points are included in the analysis.

Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe).

Outcome measures

Outcome measures
Measure	Robotic Assisted TKA n=133 Knee Robotic Assisted TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty	Conventional TKA n=48 Knee Conventional TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty
Oxford Preop	24.6 score on a scale Standard Deviation 9.2	22.2 score on a scale Standard Deviation 8.2
Oxford 6 Week	32.0 score on a scale Standard Deviation 7.6	32.5 score on a scale Standard Deviation 6.8
Oxford 3 Month	38.2 score on a scale Standard Deviation 6.8	38.5 score on a scale Standard Deviation 6.9
Oxford 1 Year	42.4 score on a scale Standard Deviation 5.4	41.2 score on a scale Standard Deviation 5.8

PRIMARY outcome

Timeframe: 6 weeks, 3 months, and 1 year

Population: Only subjects with Patient Satisfaction form at the follow-up time points are included in the analysis.

Post-Operative Pain \& Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied.

Outcome measures

Outcome measures
Measure	Robotic Assisted TKA n=124 Knee Robotic Assisted TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty	Conventional TKA n=44 Knee Conventional TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty
Post-Operative Pain & Satisfaction 6 Week · Very Satisfied	80 Knee	32 Knee
Post-Operative Pain & Satisfaction 6 Week · Satisfied	32 Knee	9 Knee
Post-Operative Pain & Satisfaction 6 Week · Uncertain	12 Knee	2 Knee
Post-Operative Pain & Satisfaction 6 Week · Unsatisfied	0 Knee	1 Knee
Post-Operative Pain & Satisfaction 3 Month · Very Satisfied	89 Knee	34 Knee
Post-Operative Pain & Satisfaction 3 Month · Satisfied	22 Knee	7 Knee
Post-Operative Pain & Satisfaction 3 Month · Uncertain	9 Knee	1 Knee
Post-Operative Pain & Satisfaction 3 Month · Unsatisfied	0 Knee	0 Knee
Post-Operative Pain & Satisfaction 1 Year · Very Satisfied	77 Knee	23 Knee
Post-Operative Pain & Satisfaction 1 Year · Satisfied	11 Knee	8 Knee
Post-Operative Pain & Satisfaction 1 Year · Uncertain	6 Knee	3 Knee
Post-Operative Pain & Satisfaction 1 Year · Unsatisfied	1 Knee	0 Knee

PRIMARY outcome

Timeframe: Pre-op (Baseline), 6 weeks, 3 months, and 1 year

Population: Only subjects with valid ROM scores at the follow-up time points are included in the analysis.

Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop

Outcome measures

Outcome measures
Measure	Robotic Assisted TKA n=133 Knee Robotic Assisted TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty	Conventional TKA n=48 Knee Conventional TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty
Total Range of Motion Preop	121.0 degrees Standard Deviation 13.9	115.7 degrees Standard Deviation 16.2
Total Range of Motion 6 Week	114.5 degrees Standard Deviation 12.9	111.4 degrees Standard Deviation 11.1
Total Range of Motion 3 Month	121.1 degrees Standard Deviation 11.0	120.7 degrees Standard Deviation 9.7
Total Range of Motion 1 Year	122.7 degrees Standard Deviation 9.5	120.4 degrees Standard Deviation 10.8

Adverse Events

Robotic Assisted TKA

Serious events: 7 serious events

Other events: 52 other events

Deaths: 0 deaths

Conventional TKA

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Robotic Assisted TKA n=133 participants at risk Robotic Assisted TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty	Conventional TKA n=48 participants at risk Conventional TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty
Surgical and medical procedures Transverse Femur Fracture at site of ROSA pins	0.75% 1/133 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.	0.00% 0/48 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.
Musculoskeletal and connective tissue disorders Patient seen for 2nd opinion at another orthopaedic provider. Diagnosed with tibial Loosening	0.75% 1/133 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.	0.00% 0/48 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.
Musculoskeletal and connective tissue disorders Stiffness/Limited Motion due to missing PT; Patient underwent open lysis of adhesions and poly swap.	0.75% 1/133 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.	0.00% 0/48 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/133 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.	2.1% 1/48 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.
Musculoskeletal and connective tissue disorders Patellar Periprosthetic Fracture	1.5% 2/133 • Number of events 2 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.	0.00% 0/48 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.
Blood and lymphatic system disorders Anemia and Melena	0.75% 1/133 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.	0.00% 0/48 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.
Vascular disorders Calf Pain/Possible DVT	0.75% 1/133 • Number of events 1 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.	0.00% 0/48 • All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year. Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.

Other adverse events

Additional Information

Director of Clinical Operations

Zimmer Biomet, Inc.

Phone: 8006136131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60