Total Joint Replacement Surgery Clinical Trial
Official title:
A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement
| NCT number | NCT03777007 |
| Other study ID # | 48386 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 26, 2019 |
| Est. completion date | April 19, 2022 |
| Verified date | March 2023 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 55 |
| Est. completion date | April 19, 2022 |
| Est. primary completion date | April 19, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Stanford University | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Derek Amanatullah |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Length of Stay in Hospital Through Discharge | Length of stay will depend on the score generated by device. | Up to 8 days | |
| Secondary | Gait Aid Use | The gait aide use ranges in the order of decreasing performance as Nothing > Cane/Walking Sticks > crutch > walker. | Preoperative and month 3 post-surgery | |
| 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. | Month 3 post-surgery | |
| 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. |
Preoperative and month 3 post-surgery |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03776357 -
A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement
|
N/A |