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

NCT03776357 | Terminated Results FDA Device

• 1 other identifier: 46061
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Total Joint Replacement Surgery

Outcome Measures

Primary Outcomes (1)

• Length of Stay in Hospital Through Discharge

  Up to 2 days

Secondary Outcomes (3)

• Number of Participants Requiring Gait Aid Use

  3 months post operative visit

• Knee Society Score (KSS)

  3 months post operative visit

• Knee Range of Motion

  3 months post operative visit

Study Arms (1)

Experimental

EXPERIMENTAL

The application used is build upon the company's category-defining, FDA- cleared Virtual Exercise Rehabilitation Assistant (VERA™) 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: VERA clinic

Interventions

VERA clinic DEVICE

A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic and at home.

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 outpatient center

Redwood City, California, 94063, United States

Location

Limitations and Caveats

The study terminated early and did not meet its planned enrollment size.

Results Point of Contact

• Title: Derek Amanatullah, MD, PhD
• Organization: Stanford University

dfa@stanford.edu

650-723-2257

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• 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 14, 2018
• Study Start: August 26, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: June 30, 2022
• Results First Posted: June 30, 2022

Record last verified: 2022-06

Locations

US (1)