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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377102
• Other study ID #: 14-2152
• Status: Completed
• Phase: N/A
• First received: February 25, 2015
• Last updated: November 10, 2017
• Start date: February 2015
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Physical Therapy
12 weeks of supervised physical therapy.

Locations

Country	Name	City	State
United States	UNC Orthopaedics	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of surgical intervention questionnaire	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.	12 weeks
Secondary	PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score	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.	12 weeks