- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02872337
Pre-operative One-on-One Physical Therapy Education Improves Postoperative Function and Patient Satisfaction After Total Joint Arthroplasty
One-on-One Physical Therapy Education Improves Postoperative Function and Patient Satisfaction After TJA
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Subjects will be required to meet the following inclusion criteria in order to participate:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental (Intervention): PreopPT Group
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
|
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
|
|
Placebo Comparator: Control (standard of care): No PreopPT Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of In-patient Physical Therapy visits required to meet hospital discharge criteria PT
Time Frame: Through Study Completion, an average of 3 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: This standard patient reported outcome was filled out preoperatively or at six weeks postoperatively
|
This standard patient reported outcome was filled out preoperatively or at six weeks postoperatively
|
This standard patient reported outcome was filled out preoperatively or at six weeks postoperatively
|
|
Patient Satisfaction Scores
Time Frame: from two weeks prior to surgery until 6 weeks after surgery
|
Patient satisfaction was measured by a series of patient administered questionnaires at various stages of the study.
All satisfaction questions, with the exception of the utilization of the microsites [Yes/No], were asked via a visual analogue scale to disagree or agree with given statements [0-5, where 0 was strongly disagree, 3 was neutral and 5 was strongly agree].
Patients unable to complete any forms at the time of the appointment completed the form over the phone with a co-investigator.
|
from two weeks prior to surgery until 6 weeks after surgery
|
|
Time to meet Physical Therapy discharge criteria
Time Frame: Time from Surgery to meeting PT discharge criteria, an average of 3 days
|
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.
|
Time from Surgery to meeting PT discharge criteria, an average of 3 days
|
|
Hospital Length of Stay
Time Frame: Time from Surgery until Hospital Discharge, an average of 2-3 days
|
collected from a hospital database
|
Time from Surgery until Hospital Discharge, an average of 2-3 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2015-306
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