Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis

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: NCT02377102
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

Purpose: For the target population of adult patients with end stage osteoarthritis, this randomized clinical trial will be used to evaluate the benefit of three months of physical therapy compared to no treatment in patients indicated for total knee arthroplasty.

Participants:Patients that are diagnosed with end stage osteoarthritis who are indicated for total knee arthroplasty.

Procedures: Patients will be randomized to either receive physical therapy or no treatment. They will be scheduled to return in 3 months for discussion of operative versus continued nonoperative treatment of their osteoarthritis.This will be determined by change in PROMIS (Patient Reported Outcome Measurement Information System) score and prevention of surgery.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Physical Therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
Study Start Date : February 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Observational
Patients will be asked to continue for 12 weeks of nonoperative medical management without physical therapy. At 12 weeks they will be reevaluated regarding the need for total knee arthroplasty.
Active Comparator: Physical Therapy
Patients will be provided a prescription for 12 weeks of physical therapy at a location of their choice. No set protocol will be issued to allow for adjustments based on patient activity level and the therapist's professional choice. The physical therapy techniques, consisting of active and passive physiological and accessory movements and soft tissue mobilization, active range of motion exercises, muscle strengthening, muscle stretching, and exercises such as riding a stationary bicycle will be applied at the discretion of the treating physical therapist primarily to the knee and surrounding structures.
Procedure: Physical Therapy
12 weeks of supervised physical therapy.




Primary Outcome Measures :
  1. Prevention of surgical intervention questionnaire [ Time Frame: 12 weeks ]
    Following Physical Therapy or observation, the patients (who are indicated for total knee replacement) will be asked if they desire a surgical intervention or if they would like to continue nonoperative management.


Secondary Outcome Measures :
  1. PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score [ Time Frame: 12 weeks ]
    The PROMIS score incorporates questions from multiple validated instruments of functional outcome. The system was then calibrated to the normal population distribution and has been applied previously to assess lower extremity dysfunction. This will increase our sensitivity in detecting differences between the two groups. The CAT is an adaptive test that responds to previous patient responses to decrease the amount of questions required to obtain a score. This will allow our CAT to last 1-5 minutes as opposed to a longer patient reported score or system. PROMIS has also been utilized in the setting of arthritis and should allow for a greater detection of functional improvement.



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:

  • Adult patients with grade 3 and 4 (severe) osteoarthritis and indicated for primary total knee arthroplasty.

Exclusion Criteria:

  • Age less than 18 y/o
  • Any form of arthritis other than osteoarthritis (traumatic, rheumatic, etc)
  • Previous knee surgery
  • Inability to personally consent to or participate with therapy due to cognitive impairment, physical disability, intoxication or sedation
  • known contraindications would include patients that will be unable to participate with therapy or who will put themselves at significant risk due to therapy (this could be either severe cardiac or respiratory impairment that prevents the patient from ambulating or mental impairment preventing the patients from following instructions

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): NCT02377102


Locations
Layout table for location information
United States, North Carolina
UNC Orthopaedics
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Layout table for investigator information
Study Director: Daniel J Del Gaizo, MD UNC Orthopaedics
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02377102    
Other Study ID Numbers: 14-2152
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases