NCT02911389

Brief Summary

The purpose of this study is to determine if unsupervised, home rehabilitation delivered by a web-based platform or paper manual is a safe and effective alternative to outpatient physical therapy after total knee replacement.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

September 15, 2016

Last Update Submit

September 19, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knee Range of Motion

    Measured in degrees from 0-130

    1 month post surgery

Study Arms (3)

Home PT via web-based platform

ACTIVE COMPARATOR

unsupervised, home rehabilitation delivered by a web-based platform

Other: Home PT via web-based platform

Home PT via paper manual

ACTIVE COMPARATOR

unsupervised, home rehabilitation delivered by a paper manual

Other: Home PT via paper manual

outpatient PT

ACTIVE COMPARATOR

outpatient physical therapy

Other: outpatient PT

Interventions

Home PT via web-based platform
Home PT via paper manual
outpatient PT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Any patient undergoing unilateral, primary TKA

You may not qualify if:

  • Patients without access to the Internet
  • Patients without access to outpatient PT
  • Revision or conversion TKA
  • Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19148, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 22, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations