Trial Outcomes & Findings for Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty (NCT NCT03023410)

Results Overview

The objective is to evaluate and link the possible causes of early TKA revision procedures using intraoperative sensors in effort to understand why knees fail in addition to examining the economic implications to the patient and hospital.

Recruitment status

TERMINATED

Target enrollment

1 participants

Primary outcome timeframe

12-months

Results posted on

2025-01-29

Participant Flow

The investigator decided to terminate the study because the evaluable population required for the study was very limited after only one subject was recruited during the one-year recruitment period.

Participant milestones

Participant milestones
Measure	Partial Revision A "partial" revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component. VERASENSE: Sensor-Assisted Revision TKA	Total Revision A "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner). VERASENSE: Sensor-Assisted Revision TKA
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Partial Revision A "partial" revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component. VERASENSE: Sensor-Assisted Revision TKA	Total Revision A "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner). VERASENSE: Sensor-Assisted Revision TKA
Overall Study study termination	0	1

Baseline Characteristics

No data were collected for Sex/Gender

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Partial Revision A "partial" revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component. VERASENSE: Sensor-Assisted Revision TKA	Total Revision n=1 Participants A "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner). VERASENSE: Sensor-Assisted Revision TKA	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=1 Participants	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	—	1 Participants n=1 Participants	1 Participants n=1 Participants
Age, Categorical >=65 years	—	0 Participants n=1 Participants	0 Participants n=1 Participants
Sex/Gender, Customized unknown	—	—	0 Participants No data were collected for Sex/Gender
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12-months

Population: 12 months follow up did not occur due to study termination

The objective is to evaluate and link the possible causes of early TKA revision procedures using intraoperative sensors in effort to understand why knees fail in addition to examining the economic implications to the patient and hospital.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: No outcome data was analyzed because of study termination before reaching 12 months period

This survey is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs. Patient expectations as well as patient satisfaction are also evaluated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from Baseline at 12-months

Population: no outcome data was analyzed because of study termination before reaching 12 months period

This survey is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal 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

Adverse Events

Partial Revision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Total Revision

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Partial Revision Revision of tibial liner.	Total Revision n=1 participants at risk Revision of all components
Musculoskeletal and connective tissue disorders Operative site	— 0/0 • Date of inclusion to date of termination up to 6 months No patient was enrolled to the "partial revision" group.	100.0% 1/1 • Number of events 1 • Date of inclusion to date of termination up to 6 months No patient was enrolled to the "partial revision" group.

Additional Information

Kevin Barga

Stryker

Phone: +12018315073

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place