Trial Outcomes & Findings for A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement (NCT NCT03776357)

NCT ID: NCT03776357

Last Updated: 2022-06-30

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: Up to 2 days
• Results posted on: 2022-06-30

Participant Flow

Participant milestones

Measure	Experimental Participants utilize FDA cleared Virtual Exercise Rehabilitation Assistant (VERA™) platform during pre-operative visit to obtain functional outcome scores.
Overall Study STARTED	9
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Experimental Participants utilize FDA cleared Virtual Exercise Rehabilitation Assistant (VERA™) platform during pre-operative visit to obtain functional outcome scores.
Overall Study Lost to Follow-up	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Experimental n=9 Participants Participants utilize the VERA platform during pre-operative visit to obtain functional outcome scores.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants
Gait aide use Nothing	9 Participants n=5 Participants
Gait aide use Cane	0 Participants n=5 Participants
Gait aide use crutch	0 Participants n=5 Participants
Gait aide use walker	0 Participants n=5 Participants
Range of motion ( maximum degrees) Extension	0.6 degrees STANDARD_DEVIATION 1.7 • n=5 Participants
Range of motion ( maximum degrees) Flexion	117.8 degrees STANDARD_DEVIATION 5.7 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 days

Outcome measures

Measure	Experimental n=9 Participants Participants utilize the VERA platform during pre-operative visit to obtain functional outcome scores.
Length of Stay in Hospital Through Discharge	2 days Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: 3 months post operative visit

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

Outcome measures

Measure	Experimental n=9 Participants Participants utilize the VERA platform during pre-operative visit to obtain functional outcome scores.
Number of Participants Requiring Gait Aid Use None ( no gait aide)	9 Participants
Number of Participants Requiring Gait Aid Use Cane	0 Participants
Number of Participants Requiring Gait Aid Use Crutch	0 Participants
Number of Participants Requiring Gait Aid Use Walker	0 Participants

SECONDARY outcome

Timeframe: 3 months post operative visit

To assess the effectiveness of the device by calculating knee society score (KSS) after 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

Measure	Experimental n=9 Participants Participants utilize the VERA platform during pre-operative visit to obtain functional outcome scores.
Knee Society Score (KSS) Excellent (80-100)	6 Participants
Knee Society Score (KSS) Good (70-79)	0 Participants
Knee Society Score (KSS) Fair (60-69)	2 Participants
Knee Society Score (KSS) Poor ( below 60)	1 Participants

SECONDARY outcome

Timeframe: 3 months post operative visit

To assess the effectiveness of the device by calculating range of motion (maximum degrees)

Outcome measures

Measure	Experimental n=9 Participants Participants utilize the VERA platform during pre-operative visit to obtain functional outcome scores.
Knee Range of Motion extension	1.1 degrees Standard Deviation 2.2
Knee Range of Motion flexion	107.8 degrees Standard Deviation 17.5

Adverse Events

Experimental

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 Amanatullah, MD, PhD

Stanford University

Phone: 650-723-2257

Email: dfa@stanford.edu

Results disclosure agreements

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