Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Formal vs. Home-Based Physical Therapy After Unicompartmental Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02883998
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
Rothman Institute Orthopaedics
Information provided by (Responsible Party):
Craig J Della Valle, MD, Rush University Medical Center

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).

Condition or disease Intervention/treatment Phase
Osteoarthritis Other: Outpatient Physical Therapy Other: Home Base Physical Therapy Not Applicable

Detailed Description:

Given that current practice trends are requiring treatments to be both clinically and cost effective, research has begun to focus on evaluating the effect of specific interventions. Many surgeon and patients have believed formal OPT is necessary to optimize functional outcomes following orthopaedic procedures. However, the literature has begun to call into question the need for OPT following total hip arthroplasty, total knee arthroplasty, total shoulder arthroplasty, anterior cruciate ligament reconstruction, meniscectomy, and rotator cuff repair.

A randomized controlled trial was done to compare face-to-face rehabilitation with in-home telerehabilitation following total knee arthroplasty. Utilizing the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as the primary outcome, the authors demonstrated noninferiority of telerehabilitation compared to face-to-face rehabilitation. Other secondary outcomes of Knee Injury and Osteoarthritis Outcome Score (KOOS), range of motion, and isometric strength did not exhibit a difference between the treatment groups. (see citation below)

Based on these findings, it appears that the high cost of formal OPT doesn't translate into a meaningful improvement of functional outcome. Because patient's undergoing UKA have a higher pre-operative functional status than patients having a TKA (Total Knee Arthroplasty), it is reasonable to think that patients following a UKA are better equipped to succeed with HBPT. As a result, the hypothesis of the current study is that HBPT will prove to be non-inferior to formal OPT in the setting of UKA.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Formal vs. Home-Based Physical Therapy After Unicompartmental Knee
Actual Study Start Date : August 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Outpatient Physical Therapy Group
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
traditional outpatient physical therapy which occurs at a physical therapy office

Experimental: Home Base Physical Therapy Group
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
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




Primary Outcome Measures :
  1. Change from baseline in Knee Society Score [ Time Frame: at 3 weeks, 3 months, and 1 year after surgery ]
  2. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: at 3 weeks, 3 months, and 1 year after surgery ]
  3. Change from baseline in Knee range of motion [ Time Frame: at 3 weeks, 3 months, and 1 year after surgery ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: Will be assessed at 3 weeks, 3 months, and 1 year after surgery ]
    Deep Vein Thrombosis or Pulmonary Embolus Return to the OR within 30 days Re-admission within 30 days Superficial infection Deep infection Periprosthetic fracture Knee stiffness (defined as < 90 degrees flexion at 3 weeks post-operative or < 110 degrees flexion at 6 weeks post-operative)

  2. Cost comparison [ Time Frame: Will be assessed at 3 weeks, 3 months, and 1 year after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for a unicompartmental knee arthroplasty

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883998


Locations
Layout table for location information
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Rothman Institute Orthopaedics
Investigators
Layout table for investigator information
Principal Investigator: Craig Della Valle, MD Rush University Medical Center
Publications:
Layout table for additonal information
Responsible Party: Craig J Della Valle, MD, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02883998    
Other Study ID Numbers: 16021505
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Craig J Della Valle, MD, Rush University Medical Center:
home-based physical therapy
outpatient physical therapy
unicompartmental knee arthroplasty
PT (Physical Therapy)
osteoarthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases