Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients — KneeMD  

Flexion Contracture Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Contracture
• Flexion Contracture

• NCT number: NCT02638480
• Study type: Interventional
• Source: Anne Arundel Health System Research Institute
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Completion date: April 2019