Total Joint Replacement Surgery
Conditions
Brief summary
SPARTA force plate is used as rehabilitation tool in this study. The device is Force Plate coupled with SPARTA scan software that enables quick assessment of individual movement and balance within minutes. The magnitude as well as efficiency of force production is analyzed to determine an patient recovery graph.
Detailed description
The investigator hope to learn co-relation between the rehab tool and clinical findings and analyse association if any. In this study, force plate is rehab tool, which 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
DEVICESPARTA force plate
The Sparta Platform includes force plate hardware coupled with Sparta Scan software that enables quick assessment of an individual's movement and balance within minutes
Sponsors
Derek Amanatullah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
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 | Description |
|---|---|---|
| Length of Stay in Hospital Through Discharge | Up to 8 days | Length of stay will depend on the score generated by device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Aid Use | Preoperative and month 3 post-surgery | The gait aide use ranges in the order of decreasing performance as Nothing \> Cane/Walking Sticks \> crutch \> walker. |
| Knee Society Score (KSS) | 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. |
| Range of Motion | Preoperative and month 3 post-surgery | 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. |
Countries
United States
Participant flow
Pre-assignment details
55 participants signed informed consent; 40 were allocated to the study arm
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Sparta Force Plate |
|---|---|
| Age, Continuous | 64.83 years STANDARD_DEVIATION 9.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Length of Stay in Hospital Through Discharge
Length of stay will depend on the score generated by device.
Time frame: Up to 8 days
Population: Participants with available data are included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sparta Force Plate | Length of Stay in Hospital Through Discharge | 3 days |
Secondary
Gait Aid Use
The gait aide use ranges in the order of decreasing performance as Nothing \> Cane/Walking Sticks \> crutch \> walker.
Time frame: Preoperative and month 3 post-surgery
Population: Participants with available data at each time point are included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sparta Force Plate | Gait Aid Use | Preoperative | None | 37 Participants |
| Sparta Force Plate | Gait Aid Use | Preoperative | Cane/Walking Sticks | 3 Participants |
| Sparta Force Plate | Gait Aid Use | Month 3 | None | 38 Participants |
| Sparta Force Plate | Gait Aid Use | Month 3 | Cane/Walking Sticks | 0 Participants |
Secondary
Knee Society Score (KSS)
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.
Time frame: Month 3 post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sparta Force Plate | Knee Society Score (KSS) | 90.4 score on a scale | Standard Deviation 11.39 |
Secondary
Range of Motion
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.
Time frame: Preoperative and month 3 post-surgery
Population: Participants with available data at each time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sparta Force Plate | Range of Motion | Extension - month 3 | 0.3 degrees | Standard Deviation 1.15 |
| Sparta Force Plate | Range of Motion | Flexion - preoperative | 113.9 degrees | Standard Deviation 11.78 |
| Sparta Force Plate | Range of Motion | Flexion - month 3 | 116.0 degrees | Standard Deviation 8.54 |
| Sparta Force Plate | Range of Motion | Extension - preoperative | 2.4 degrees | Standard Deviation 3.34 |