Trial Outcomes & Findings for A Trial Evaluating TKR Compared to BKR Performed Using Stryker's Mako Robot (NCT NCT02650284)

NCT ID: NCT02650284

Last Updated: 2022-06-29

Results Overview

Comparing clinical outcomes using the Oxford Knee Score. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: pre-op, 6 weeks, 3 months, 12 months, 24 months
• Results posted on: 2022-06-29

Participant Flow

Upon being assessed against the inclusion and exclusion criteria, suitable patients were randomised to one arm of the study.

In addition to the 8 Bicompartmental and 9 Total Knee replacement patients, 1 patient in the study was not randomised prior to surgery.

Participant milestones

Measure	Bicompartmental Knee Replacement (BKR) Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement
Overall Study STARTED	8	9
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Bicompartmental Knee Replacement (BKR) Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement
Overall Study Lost to Follow-up	3	3
Overall Study Consent incorrectly taken	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Bicompartmental Knee Replacement (BKR) n=8 Participants Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) n=8 Participants Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement	Total n=16 Participants Total of all reporting groups
Age, Continuous	65.0 years STANDARD_DEVIATION 4.56 • n=8 Participants	64.0 years STANDARD_DEVIATION 4.85 • n=8 Participants	65 years STANDARD_DEVIATION 4.72 • n=16 Participants
Sex: Female, Male Female	3 Participants n=8 Participants	3 Participants n=8 Participants	6 Participants n=16 Participants
Sex: Female, Male Male	5 Participants n=8 Participants	5 Participants n=8 Participants	10 Participants n=16 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Australia	8 participants n=8 Participants	8 participants n=8 Participants	16 participants n=16 Participants

PRIMARY outcome

Timeframe: pre-op, 6 weeks, 3 months, 12 months, 24 months

Population: The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).

Comparing clinical outcomes using the Oxford Knee Score. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.

Outcome measures

Measure	Bicompartmental Knee Replacement (BKR) n=8 Participants Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) n=8 Participants Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement
Oxford Knee Score Oxford pre-operative	22.63 units on a scale Standard Deviation 8.14	26.75 units on a scale Standard Deviation 8.90
Oxford Knee Score Oxford 6-weeks	34.00 units on a scale Standard Deviation 6.69	30.14 units on a scale Standard Deviation 3.80
Oxford Knee Score Oxford 3-months	39.00 units on a scale Standard Deviation 3.61	33.29 units on a scale Standard Deviation 7.63
Oxford Knee Score Oxford 12-months	40.43 units on a scale Standard Deviation 4.17	40.33 units on a scale Standard Deviation 7.95
Oxford Knee Score Oxford 24-months	41.20 units on a scale Standard Deviation 5.49	43.75 units on a scale Standard Deviation 3.34

SECONDARY outcome

Timeframe: 24 months/ 2years

Population: The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).

Comparing functional and clinical outcomes using the EQ-5D. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. Index values range from 0-1, with 1 being representing "full health". The EQ VAS records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 ='Best imaginable health state' to 0= 'Worst imaginable health state'. The VAS scales represents health on the day.

Outcome measures

Measure	Bicompartmental Knee Replacement (BKR) n=8 Participants Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) n=8 Participants Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement
Health Related Quality of Life EQ-5D Pre-op EQ-5D Index	0.16 units on a scale Standard Deviation 0.45	0.28 units on a scale Standard Deviation 0.40
Health Related Quality of Life EQ-5D Pre-op EQ-5D VAS	78.50 units on a scale Standard Deviation 12.22	81.50 units on a scale Standard Deviation 12.21
Health Related Quality of Life EQ-5D 3-month EQ-5D Index	0.69 units on a scale Standard Deviation 0.35	0.66 units on a scale Standard Deviation 0.31
Health Related Quality of Life EQ-5D 3-month EQ-5D VAS	82.25 units on a scale Standard Deviation 12.67	90.00 units on a scale Standard Deviation 13.35
Health Related Quality of Life EQ-5D 12-month EQ-5D Index	0.48 units on a scale Standard Deviation 0.41	0.65 units on a scale Standard Deviation 0.45
Health Related Quality of Life EQ-5D 12-month EQ-5D VAS	74.50 units on a scale Standard Deviation 10.13	89.20 units on a scale Standard Deviation 10.23
Health Related Quality of Life EQ-5D 24-month EQ-5D Index	0.63 units on a scale Standard Deviation 0.62	0.89 units on a scale Standard Deviation 0.13
Health Related Quality of Life EQ-5D 24-month EQ-5D VAS	80.40 units on a scale Standard Deviation 11.36	87.25 units on a scale Standard Deviation 10.62

SECONDARY outcome

Timeframe: 24 months/ 2years

Population: The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).

Comparing functional and clinical outcomes using the VAS pain. Pain at rest and pain during mobilization are measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 100 being the worst pain.

Outcome measures

Measure	Bicompartmental Knee Replacement (BKR) n=8 Participants Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) n=8 Participants Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement
VAS Pain Pre-op VAS Pain at rest	36.63 units on a scale Standard Deviation 26.89	36.14 units on a scale Standard Deviation 21.91
VAS Pain Pre-op VAS Pain at mobilization	65.00 units on a scale Standard Deviation 25.63	56.86 units on a scale Standard Deviation 25.18
VAS Pain 3-month VAS Pain at rest	12.00 units on a scale Standard Deviation 17.45	22.25 units on a scale Standard Deviation 18.46
VAS Pain 3-month VAS Pain at mobilization	23.67 units on a scale Standard Deviation 29.44	24.25 units on a scale Standard Deviation 16.41
VAS Pain 12-month VAS Pain at rest	10.40 units on a scale Standard Deviation 9.41	19.00 units on a scale Standard Deviation 32.91
VAS Pain 12-month VAS Pain at mobilization	13.60 units on a scale Standard Deviation 9.65	24.25 units on a scale Standard Deviation 34.40
VAS Pain 24-month VAS Pain at rest	0.67 units on a scale Standard Deviation 0.47	3.50 units on a scale Standard Deviation 2.69
VAS Pain 24-month VAS Pain at mobilization	2.33 units on a scale Standard Deviation 1.70	7.75 units on a scale Standard Deviation 4.60

SECONDARY outcome

Timeframe: 24 months/ 2years

Population: The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).

Comparing functional and clinical outcomes using the KSS. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

Outcome measures

Measure	Bicompartmental Knee Replacement (BKR) n=8 Participants Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) n=8 Participants Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement
New Knee Society Score (KSS) KSS function at pre-operation	44.29 units on a scale Standard Deviation 9.65	48.00 units on a scale Standard Deviation 15.59
New Knee Society Score (KSS) KSS function at 3-month	76.44 units on a scale Standard Deviation 12.08	61.00 units on a scale Standard Deviation 15.34
New Knee Society Score (KSS) KSS function at 24-month	84.50 units on a scale Standard Deviation 9.39	85.33 units on a scale Standard Deviation 10.40

SECONDARY outcome

Timeframe: 24 months/ 2years

Population: The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).

Comparing functional and clinical outcomes using the FJS. The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).

Outcome measures

Measure	Bicompartmental Knee Replacement (BKR) n=8 Participants Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) n=8 Participants Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement
Forgotten Joint Score (FJS) FJS pre-operative	11.60 units on a scale Standard Deviation 3.56	13.75 units on a scale Standard Deviation 5.53
Forgotten Joint Score (FJS) FJS 3-month	51.30 units on a scale Standard Deviation 25.92	30.36 units on a scale Standard Deviation 25.41
Forgotten Joint Score (FJS) FJS 12-month	58.63 units on a scale Standard Deviation 27.04	63.19 units on a scale Standard Deviation 32.40
Forgotten Joint Score (FJS) FJS 24-month	64.58 units on a scale Standard Deviation 23.46	66.67 units on a scale Standard Deviation 19.60

SECONDARY outcome

Timeframe: 6 weeks, 3 months, 12 months, 24 months

Population: Image quality not obtained to perform incidence calculations thus the incidence of loosening, reoperation and revision detailed below are solely based off the Serious Adverse Events and Adverse Events reported. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).

To compare incidence of loosening, reoperation and revision rates. The incidence (ie number of participants who experienced lossening, reoperation or revision) will be counted and presented as a whole number or percentage of the total number of patients, however they will be identified from analysing Xrays and checking Serious Adverse Event/ Adverse Event reports.

Outcome measures

Measure	Bicompartmental Knee Replacement (BKR) n=8 Participants Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) n=8 Participants Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement
Incidence of Loosening, Reoperation and Revision Incidence of loosening	0 Participants	0 Participants
Incidence of Loosening, Reoperation and Revision Incidence of reoperation	0 Participants	0 Participants
Incidence of Loosening, Reoperation and Revision Incidence of revision	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: The number of recruited patients did not reach the required sample size. 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).

To compare length of hospital stay between the two arms of the study

Outcome measures

Measure	Bicompartmental Knee Replacement (BKR) n=8 Participants Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) n=8 Participants Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement
Length of Hospital Stay	3 Number of nights Standard Deviation 1.32	2.86 Number of nights Standard Deviation 0.64

Adverse Events

Bicompartmental Knee Replacement (BKR)

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Total Knee Replacement (TKR)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bicompartmental Knee Replacement (BKR) n=8 participants at risk Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) n=8 participants at risk Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement
Musculoskeletal and connective tissue disorders Contralateral knee osteoarthirits	12.5% 1/8 • Number of events 1 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).	0.00% 0/8 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).
Musculoskeletal and connective tissue disorders Contralateral knee pain	12.5% 1/8 • Number of events 1 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).	0.00% 0/8 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).
Musculoskeletal and connective tissue disorders Contralateral Bicompartmental Knee Replacement	12.5% 1/8 • Number of events 1 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).	0.00% 0/8 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).
Cardiac disorders Chest pain	12.5% 1/8 • Number of events 1 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).	0.00% 0/8 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).
Cardiac disorders Internal Cardiac Defibrillator implanted	12.5% 1/8 • Number of events 1 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).	0.00% 0/8 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).

Other adverse events

Measure	Bicompartmental Knee Replacement (BKR) n=8 participants at risk Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako Restoris MCK Multicompartmental Knee System: Bicompartmental Knee Replacement	Total Knee Replacement (TKR) n=8 participants at risk Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako Stryker Triathlon Primary Total Knee System: Total Knee Replacement
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.00% 0/8 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).	12.5% 1/8 • Number of events 1 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).
Musculoskeletal and connective tissue disorders Lateral knee pain and anterior fat pad impingement	12.5% 1/8 • Number of events 1 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).	0.00% 0/8 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/8 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).	12.5% 1/8 • Number of events 1 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).
Ear and labyrinth disorders Sinus and ear infection	0.00% 0/8 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).	12.5% 1/8 • Number of events 1 • 2 years post-operation 1 patient in the Total Knee study arm was consented incorrectly and their data could not be used in analyses (i.e. reducing the number of participants in this study arm to 8).

Additional Information

Alissa Connelly

Stryker

Phone: +61294671000

Email: alissa.connelly@stryker.com

Results disclosure agreements

• Principal investigator is a sponsor employee Since the study has been discontinued due to the sample size not being reached, the data cannot be analysed and there are no trial results to discuss/ publish.
• Publication restrictions are in place

Restriction type: OTHER