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Traditional PT v Internet Based PT After Total Knee Arthroscopy

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: NCT04843280
Recruitment Status : Completed
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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Brief Summary:

Knee arthroscopy results in significant improvements in functional outcomes, pain relief and quality of life for patients suffering from mechanical symptoms associated with meniscal tears. Patients are able to return to their activities of daily living, occupation, or sport without significant limitations. Traditionally, patients have undergone formal physical therapy (PT) after knee arthroscopy to regain function. There is a significant cost and time commitment associated with traditional outpatient physical therapy. An internet based therapy program allows patients to perform therapy at home on their own time schedule. A recent study demonstrated that patients who undergo internet based PT after total knee arthroplasty performed as well patients receiving traditional physical therapy. These findings have not been studied in the knee arthroscopy patient population. The goal of this study is to compare traditional outpatient physical therapy rehabilitation to Internet-based rehabilitation in patients undergoing knee arthroscopy for partial meniscectomy.

The purpose of this study is to compare functional outcome, and patient satisfaction, internet-based rehabilitation program vs. standard outpatient physical therapy after unilateral knee arthroscopy for meniscal tear.


Condition or disease Intervention/treatment Phase
Physical Therapy Procedure: FORCE therapeutics (physical therapy) Procedure: Traditional Outpatient Physical Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Traditional Physical Therapy to Internet-Based Physical Therapy After Knee Arthroscopy: A Prospective Randomized Controlled Trial Comparing Patient Outcomes and Satisfaction
Actual Study Start Date : July 30, 2017
Actual Primary Completion Date : February 19, 2019
Actual Study Completion Date : February 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
Drug Information available for: Coal Tar

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Traditional Physical Therapy
Participants who have undergone primary unilateral knee arthroscopy will undergo 6 weeks of formal outpatient physical therapy
 Procedure: Traditional Outpatient Physical Therapy
6 weeks of outpatient physical therapy following arthroscopic knee surgery
Active Comparator: Internet Based Physical Therapy
Participants who have undergone primary unilateral knee arthroscopy will undergo 6 weeks of internet based rehabilitation regime in the home through the online recovery program, FORCE Therapeutics
 Procedure: FORCE therapeutics (physical therapy)
6 weeks of internet based physical therapy following arthroscopic knee surgery


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative Knee Function [ Time Frame: 4 months ]
    Investigators will be measuring whether there is an increase in participants function as assessed by the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation. This will be measured on a scale of 0-100 with 0 being the lowest level of function and 100 being the highest level of function

  2. Cost analysis [ Time Frame: 4 months ]
    cost analysis survey will be completed by participants to determine if there is a difference in outpatient physical therapy versus internet based physical therapy

  3. Postoperative Physical therapy Patient Satisfaction [ Time Frame: 4 months ]
    Participant satisfaction with physical therapy will be assessed using the physical therapy satisfaction evaluation. This consist of a single question asking the participant how satisfied they are with their surgery on a scale of 0-10. 0 being not satisfied at all and 10 being extremely satisfied.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any patient undergoing unilateral primary knee arthroscopy for meniscal tear
  • Any patient 18 years or older

Exclusion Criteria:

  • Patients without access to the Internet
  • Post-traumatic osteoarthritis
  • Patients with ligamentous injury
  • Patients with full thickness cartilage defects
  • Patients with osteoarthritis or inflammatory arthritis
  • Revision or conversion knee arthroscopy
  • Patients receiving workers compensations
  • 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.
Contacts and Locations
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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): NCT04843280


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04843280    
Other Study ID Numbers: DMAZ17D.288
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coal Tar
Keratolytic Agents
Dermatologic Agents