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CompletedNCT03777007Updated Mar 24, 2023Results posted

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

An interventional study of SPARTA force plate in Total Joint Replacement Surgery, sponsored by Derek Amanatullah. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-03-24.

Sponsored by Derek Amanatullah · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Total Joint Replacement Surgery
03

In context

Lead sponsor

Derek Amanatullah is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts 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

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

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Experimental

    The application used is build upon the company's category-defining, SPARTA Platform and create a platform that streamlines the performance and management of post-acute care physical therapy. The rehab tool will provide us with functional outcome score.

    Device: SPARTA force plate

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

06

What researchers measure

Primary outcomes

  1. Length of Stay in Hospital Through Discharge

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

    Time frame: Up to 8 days

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Results

Posted Mar 24, 2023

Participant flow

Participant flow — Overall Study
MilestoneSparta Force Plate
Started40
Completed40
Not completed0

Outcome measures

PrimaryLength of Stay in Hospital Through Discharge

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

Time frame:
Up to 8 days
Reported as:
Median · days
Length of Stay in Hospital Through Discharge
daysSparta Force Plate
Length of Stay in Hospital Through Discharge3 (2 to 3)
SecondaryGait 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
Reported as:
Count of participants · Participants
Gait Aid Use
ParticipantsSparta Force Plate
Preoperative — None37
Preoperative — Cane/Walking Sticks3
Month 3 — None38
Month 3 — Cane/Walking Sticks0
SecondaryKnee 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
Reported as:
Mean · score on a scale
Knee Society Score (KSS)
score on a scaleSparta Force Plate
Knee Society Score (KSS)90.4 ± 11.39
SecondaryRange 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
Reported as:
Mean · degrees
Range of Motion
degreesSparta Force Plate
Extension - preoperative2.4 ± 3.34
Extension - month 30.3 ± 1.15
Flexion - preoperative113.9 ± 11.78
Flexion - month 3116.0 ± 8.54

Adverse events

Collected over Up to 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sparta Force Plate0/40 (0%)0/40 (0%)0/40 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Sparta Force Plate
Mean64.83 ± 9.34
Sex: Female, Male
Sex: Female, Male(Participants)Sparta Force Plate
Female21
Male19
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Sparta Force Plate
Hispanic or Latino3
Not Hispanic or Latino28
Unknown or Not Reported9
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sparta Force Plate
American Indian or Alaska Native1
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American1
White28
More than one race0
Unknown or Not Reported9
Region of Enrollment
Region of Enrollment(Participants)Sparta Force Plate
United States40
08

Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
09

References and documents

Study documents

  • Study protocol · Oct 8, 2021

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03777007
Lead sponsor
Derek Amanatullah
Responsible party
Derek Amanatullah (Assistant Professor, Stanford University) — Sponsor-investigator
First posted
Dec 17, 2018
Start date
Aug 26, 2019
Primary completion
Apr 19, 2022
Completion
Apr 19, 2022
Results posted
Mar 24, 2023
Last update
Mar 24, 2023

Study contacts

Derek Amanatullah, M.D. PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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