NCT02872337

Brief Summary

The purpose of this study was to evaluate the efficacy of a one-time, preoperative physical therapy protocol on postoperative (1) discharge disposition, (2) pain, function and stiffness and (3) patient satisfaction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

August 1, 2016

Last Update Submit

June 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of In-patient Physical Therapy visits required to meet hospital discharge criteria PT

    This included a review of the hospital database for hospital discharge time. At this institution PT discharge is defined as the ability to (1) independently transfer, (2) independently ambulate approximately 150 feet and (3) independently negotiate stairs (4) independent with home exercise program and activities of daily living. All of this data was recorded from hospital records

    Through Study Completion, an average of 3 days

Secondary Outcomes (4)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    This standard patient reported outcome was filled out preoperatively or at six weeks postoperatively

  • Patient Satisfaction Scores

    from two weeks prior to surgery until 6 weeks after surgery

  • Time to meet Physical Therapy discharge criteria

    Time from Surgery to meeting PT discharge criteria, an average of 3 days

  • Hospital Length of Stay

    Time from Surgery until Hospital Discharge, an average of 2-3 days

Study Arms (2)

Experimental (Intervention): PreopPT Group

EXPERIMENTAL

This group will undergo the group preoperative education session. Following this session (intervention) this group underwent a one-time, one-on-one preoperative PT session. They also were given access to a web-based microsite which was customized to surgeon

Behavioral: Preoperative Physical Therapy SessionBehavioral: Group Preoperative Education Session (per the standard of care)

Control (standard of care): No PreopPT Group

PLACEBO COMPARATOR

This group underwent the current of standard of care at our institution. This only includes the group preoperative education session. No further preoperative education was given.

Behavioral: Group Preoperative Education Session (per the standard of care)

Interventions

This was a one-on-one preoperative physical therapy session on preoperative education. These patients were also given access to a surgery specific web-based microsite

Experimental (Intervention): PreopPT Group
Control (standard of care): No PreopPT GroupExperimental (Intervention): PreopPT Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral Primary Knee OA or Hip OA
  • Patients at least 18 years old up to 85.
  • Undergoing surgery with one of the following study surgeons
  • Able to independently ambulate ≥ half a block with or without assistive device
  • Able to independently perform non-reciprocal stairs with or without assistive device/rails
  • Patients that plan to D/C home post TKA / THA
  • Patients that speak English only.

You may not qualify if:

  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Juvenile rheumatoid arthritis
  • Knee or Hip revisions
  • Patients under 18 years of age
  • Patients unwilling or unable to complete PRO instrument or study questionnaires at the specified study time points pre-operatively or post-operatively
  • Bilateral TKA and THA
  • Uni-condylar knee arthroplasty or Hip resurfacing
  • Patellar reconstruction
  • Patient on disability, workman's compensation
  • Patients unwilling to participate in PEdPTWP and/or Patient education class and booklet.
  • Patients that plan to D/C to rehabilitation center post TKA and THA
  • Patients that do not speak English
  • Patients that do not have access to computer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 19, 2016

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

June 22, 2023

Record last verified: 2023-06