Clinical Trial: Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Randomized Trial to Examine the Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients

Brief Summary: The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee rehabilitation device on the incidence of postoperative flexion contracture.

Detailed Summary:

Postoperative flexion contracture (FC), defined as >10°, is the most common disabling early complication of primary total knee replacement (TKR) surgery, affecting up to 6% of all subjects. A knee flexion of 65° is required to walk, 70° is needed to lift an object from the floor, 85° to climb stairs, 95° for optimal sitting and standing, and 105° to tie shoelaces. With growing subject and physician expectations for function and range of motion (ROM) after surgery, FC complications have become an early measure of success in TKR surgery.

The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee rehabilitation device on the incidence of postoperative FC. The primary endpoints are the preoperative change in active range of motion (AROM) and the incidence of postoperative FC at 2 weeks. Secondary endpoints include the change in AROM in subjects with postoperative FC.


Sponsor: Anne Arundel Health System Research Institute

Current Primary Outcome: AROM [ Time Frame: 4 weeks after randomization ]

Change in maximal active range of motion in


Original Primary Outcome: Same as current

Current Secondary Outcome: AROM [ Time Frame: 2 weeks postoperatively ]

Active Range of motion in degrees


Original Secondary Outcome: Same as current

Information By: Anne Arundel Health System Research Institute

Dates:
Date Received: December 18, 2015
Date Started: November 2015
Date Completion: April 2017
Last Updated: July 13, 2016
Last Verified: July 2016