Trial Outcomes & Findings for A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement (NCT NCT03777007)

NCT ID: NCT03777007

Last Updated: 2023-03-24

Results Overview

Length of stay will depend on the score generated by device.

Recruitment status

COMPLETED

Study phase

Target enrollment

55 participants

Primary outcome timeframe

Up to 8 days

Results posted on

2023-03-24

Participant Flow

55 participants signed informed consent; 40 were allocated to the study arm

Participant milestones

Participant milestones
Measure	Sparta Force Plate The Sparta platform includes force plate hardware coupled with Sparta Scan software that enables assessment of an individual's movement and balance
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sparta Force Plate n=40 Participants The Sparta platform includes force plate hardware coupled with Sparta Scan software that enables assessment of an individual's movement and balance
Age, Continuous	64.83 years STANDARD_DEVIATION 9.34 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Region of Enrollment United States	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 days

Population: Participants with available data are included in the analysis.

Length of stay will depend on the score generated by device.

Outcome measures

Outcome measures
Measure	Sparta Force Plate n=39 Participants The Sparta platform includes force plate hardware coupled with Sparta Scan software that enables assessment of an individual's movement and balance
Length of Stay in Hospital Through Discharge	3 days Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: Preoperative and month 3 post-surgery

Population: Participants with available data at each time point are included in the analysis.

The gait aide use ranges in the order of decreasing performance as Nothing \> Cane/Walking Sticks \> crutch \> walker.

Outcome measures

Outcome measures
Measure	Sparta Force Plate n=40 Participants The Sparta platform includes force plate hardware coupled with Sparta Scan software that enables assessment of an individual's movement and balance
Gait Aid Use Month 3 · Cane/Walking Sticks	0 Participants
Gait Aid Use Preoperative · None	37 Participants
Gait Aid Use Preoperative · Cane/Walking Sticks	3 Participants
Gait Aid Use Month 3 · None	38 Participants

SECONDARY outcome

Timeframe: Month 3 post-surgery

To assess the effectiveness of the device by calculating Knee Society Score (KSS) at 3 months following surgery. The scale ranges from 0-100 with grading as: Score 80-100 - Excellent; Score 70-79 - Good; Score 60-69 - Fair; Score below 60 - Poor.

Outcome measures

Outcome measures
Measure	Sparta Force Plate n=40 Participants The Sparta platform includes force plate hardware coupled with Sparta Scan software that enables assessment of an individual's movement and balance
Knee Society Score (KSS)	90.4 score on a scale Standard Deviation 11.39

SECONDARY outcome

Timeframe: Preoperative and month 3 post-surgery

Population: Participants with available data at each time point are included in the analysis.

To assess the effectiveness of the device by calculating range of motion (extension and flexion). Higher extension scores and lower flexion scores represent greater flexibility.

Outcome measures

Outcome measures
Measure	Sparta Force Plate n=40 Participants The Sparta platform includes force plate hardware coupled with Sparta Scan software that enables assessment of an individual's movement and balance
Range of Motion Extension - preoperative	2.4 degrees Standard Deviation 3.34
Range of Motion Extension - month 3	0.3 degrees Standard Deviation 1.15
Range of Motion Flexion - preoperative	113.9 degrees Standard Deviation 11.78
Range of Motion Flexion - month 3	116.0 degrees Standard Deviation 8.54

Adverse Events

Sparta Force Plate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Derek F. Amanatullah

Stanford University

Phone: (650) 723-2257

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place