NCT04843280

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

1.6 years

First QC Date

March 31, 2021

Last Update Submit

April 12, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Postoperative Knee Function

    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

    4 months

  • Cost analysis

    cost analysis survey will be completed by participants to determine if there is a difference in outpatient physical therapy versus internet based physical therapy

    4 months

  • Postoperative Physical therapy Patient Satisfaction

    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.

    4 months

Study Arms (2)

Traditional Physical Therapy

ACTIVE COMPARATOR

Participants who have undergone primary unilateral knee arthroscopy will undergo 6 weeks of formal outpatient physical therapy

Procedure: Traditional Outpatient Physical Therapy

Internet Based Physical Therapy

ACTIVE COMPARATOR

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)

Interventions

6 weeks of internet based physical therapy following arthroscopic knee surgery

Internet Based Physical Therapy

6 weeks of outpatient physical therapy following arthroscopic knee surgery

Traditional Physical Therapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

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

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 13, 2021

Study Start

July 30, 2017

Primary Completion

February 19, 2019

Study Completion

February 19, 2019

Last Updated

April 13, 2021

Record last verified: 2021-04

Locations