Physical Therapy Prior to Total Knee Replacement

October 28, 2014 updated by: Rothman Institute Orthopaedics

Effect of Physical Therapy on Grade 3 or 4 Knee Osteoarthritis

In this study, the investigators are investigating the effects of physical therapy (PT) for treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee replacement. Through the examination of patient outcomes, such as pain, stiffness, and physical function, the investigators will determine if PT prior to total knee replacement is an effective treatment in a patient with high grade OA.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

148

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph
  2. Surgical candidate for TKA, having had a least a 3 months of pain affecting ADL's unresponsive to conservative treatment consisting of AT LEAST one non-narcotic medication AND one injection (corticosteroid or series of viscosupplementation). Injection must not have been administered within 6 weeks of start of PT trial
  3. Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction

Exclusion Criteria:

  1. Anyone who received physical therapy in the last 6 months
  2. Inability to walk unaided for >1 block
  3. Currently engaged in regular PT or a regular home exercise program
  4. Prior knee arthroplasty
  5. Prior knee surgery for trauma, tumor and osteotomy
  6. Injection given within 6 weeks of starting therapy
  7. Patients using daily narcotic medications within prior 6 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No physical therapy
No prescribed, supervised physical therapy prior to total knee replacement
Active Comparator: Physical Therapy
Prescribed, supervised physical therapy prior to total knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Range of Motion following Total Knee Replacement
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient reported perception of pain following total knee replacement
Time Frame: 6 weeks
6 weeks
Return to functional activities following total knee replacement
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

October 6, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • Austin2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis of the Hip

Clinical Trials on Supervised physical therapy program prior to total knee replacement surgery

3
Subscribe