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

NCT ID: NCT02377102

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: PROCEDURE

12 weeks of supervised physical therapy.

Interventions

Physical Therapy

12 weeks of supervised physical therapy.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel J Del Gaizo, MD

Role: STUDY_DIRECTOR

UNC Orthopaedics

Locations

UNC Orthopaedics

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

14-2152

Identifier Type: -

Identifier Source: org_study_id