NCT02883998

Brief Summary

To determine whether home-based physical therapy (HBPT) is not clinically inferior to formal outpatient physical therapy (OPT) after hospital discharge of patients undergoing a unicompartmental knee arthroplasty (UKA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 11, 2018

Status Verified

June 1, 2018

Enrollment Period

9 months

First QC Date

August 22, 2016

Last Update Submit

June 7, 2018

Conditions

Keywords

home-based physical therapyoutpatient physical therapyunicompartmental knee arthroplastyPT (Physical Therapy)osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in Knee Society Score

    at 3 weeks, 3 months, and 1 year after surgery

  • Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index

    at 3 weeks, 3 months, and 1 year after surgery

  • Change from baseline in Knee range of motion

    at 3 weeks, 3 months, and 1 year after surgery

Secondary Outcomes (2)

  • Complications

    Will be assessed at 3 weeks, 3 months, and 1 year after surgery

  • Cost comparison

    Will be assessed at 3 weeks, 3 months, and 1 year after surgery

Study Arms (2)

Outpatient Physical Therapy Group

ACTIVE COMPARATOR

Once the patient is cleared for discharged from the hospital, the patient will be given a prescription for outpatient physical therapy to attend 3 times per week for 6 weeks.

Other: Outpatient Physical Therapy

Home Base Physical Therapy Group

EXPERIMENTAL

Patients will be provided a packet of exercises and equipment to perform the home based physical therapy program. Patients will attend a single session of outpatient physical therapy prior to surgery no more than 4 weeks prior to the procedure to teach the patient how to perform the exercises.

Other: Home Base Physical Therapy

Interventions

traditional outpatient physical therapy which occurs at a physical therapy office

Outpatient Physical Therapy Group

Patients will be provided a packet of exercises via a website which allows access to instructional physical therapy videos specifically designated for UKA patients and equipment to perform the home based physical therapy

Home Base Physical Therapy Group

Eligibility Criteria

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

You may qualify if:

  • Scheduled for a unicompartmental knee arthroplasty

You may not qualify if:

  • Require inpatient physical therapy beyond post-operative day one
  • \< 18 years old
  • Decline to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.

    PMID: 26178888BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Craig Della Valle, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 30, 2016

Study Start

August 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

June 11, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations