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

NCT02377102 | Completed

• 1 other identifier: 14-2152
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score

  12 weeks

Study Arms (2)

Observational

NO INTERVENTION

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.

Physical Therapy

ACTIVE COMPARATOR

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

Interventions

Physical Therapy PROCEDURE

12 weeks of supervised physical therapy.

Physical Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Orthopaedics

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Daniel J Del Gaizo, MD

  UNC Orthopaedics

  STUDY DIRECTOR

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: February 25, 2015
• First Posted: March 3, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-10

Locations

US (1)