Total Joint Replacement Surgery
Conditions
Brief summary
This is the research study of a rehabilitation tool that informs, guides and empowers clinicians to care for their patients. We hope to learn ways to improve patient outcomes, reduce costs and increase value to the healthcare system
Detailed description
The investigator hope to learn co-relation between the rehab tool and clinical findings and analyse association if any. Rehab tool will optimize care according to the patient's specific needs and provided insights to patients length of stay in the hospital. these data driven insights will be used to observe correlation between machine and clinic data
Interventions
DEVICEVERA clinic
A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic and at home.
Sponsors
Derek Amanatullah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for Primary unilateral total joint replacement * Patient age should be more than or equal to 18 years. * Patient must speak English
Exclusion criteria
* Patients undergoing bilateral primary knee replacement surgery * Patients undergoing revision knee replacement surgery * No uncorrectable deformity * No deformity greater than 15 degree * No hip arthritis * No wheelchair dependency * Patients not willing and capable to sign the written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Stay in Hospital Through Discharge | Up to 2 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Gait Aid Use | 3 months post operative visit | The gait aide use ranges in the order of decreasing performance as Nothing \> Cane \> crutch \> walker. |
| Knee Society Score (KSS) | 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 |
| Knee Range of Motion | 3 months post operative visit | To assess the effectiveness of the device by calculating range of motion (maximum degrees) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Participants utilize the VERA platform during pre-operative visit to obtain functional outcome scores. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gait aide use Cane | 0 Participants |
| Gait aide use crutch | 0 Participants |
| Gait aide use Nothing | 9 Participants |
| Gait aide use walker | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Range of motion ( maximum degrees) Extension | 0.6 degrees STANDARD_DEVIATION 1.7 |
| Range of motion ( maximum degrees) Flexion | 117.8 degrees STANDARD_DEVIATION 5.7 |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Length of Stay in Hospital Through Discharge
Time frame: Up to 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental | Length of Stay in Hospital Through Discharge | 2 days |
Secondary
Knee Range of Motion
To assess the effectiveness of the device by calculating range of motion (maximum degrees)
Time frame: 3 months post operative visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Knee Range of Motion | extension | 1.1 degrees | Standard Deviation 2.2 |
| Experimental | Knee Range of Motion | flexion | 107.8 degrees | Standard Deviation 17.5 |
Secondary
Knee Society Score (KSS)
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
Time frame: 3 months post operative visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental | Knee Society Score (KSS) | Excellent (80-100) | 6 Participants |
| Experimental | Knee Society Score (KSS) | Good (70-79) | 0 Participants |
| Experimental | Knee Society Score (KSS) | Fair (60-69) | 2 Participants |
| Experimental | Knee Society Score (KSS) | Poor ( below 60) | 1 Participants |
Secondary
Number of Participants Requiring Gait Aid Use
The gait aide use ranges in the order of decreasing performance as Nothing \> Cane \> crutch \> walker.
Time frame: 3 months post operative visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental | Number of Participants Requiring Gait Aid Use | Walker | 0 Participants |
| Experimental | Number of Participants Requiring Gait Aid Use | None ( no gait aide) | 9 Participants |
| Experimental | Number of Participants Requiring Gait Aid Use | Cane | 0 Participants |
| Experimental | Number of Participants Requiring Gait Aid Use | Crutch | 0 Participants |