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

NCT03777007 | Completed Results FDA Device

• 1 other identifier: 48386
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Joint Replacement Surgery

Outcome Measures

Primary Outcomes (1)

• Length of Stay in Hospital Through Discharge

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

  Up to 8 days

Secondary Outcomes (3)

• Gait Aid Use

  Preoperative and month 3 post-surgery

• Knee Society Score (KSS)

  Month 3 post-surgery

• Range of Motion

  Preoperative and month 3 post-surgery

Study Arms (1)

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

SPARTA force plate DEVICE

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

Experimental

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled for Primary unilateral total joint replacement
• Patient age should be more than or equal to 18 years.
• Patient must speak English

You may not qualify if:

• 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

Sponsors & Collaborators

• Derek Amanatullah: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Results Point of Contact

• Title: Derek F. Amanatullah
• Organization: Stanford University

dfa@stanford.edu

(650) 723-2257

Study Officials

• Derek Amanatullah, M.D. PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 17, 2018
• Study Start: August 26, 2019
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: March 24, 2023
• Results First Posted: March 24, 2023

Record last verified: 2023-03

Locations

US (1)