Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients (KneeMD)
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|ClinicalTrials.gov Identifier: NCT02638480|
Recruitment Status : Active, not recruiting
First Posted : December 23, 2015
Last Update Posted : February 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Flexion Contracture||Device: KneeMD||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Trial to Examine the Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||April 2019|
No Intervention: Control
The control subjects will be treated with only the current SOC including NSAIDs and physical therapy.
The experimental subjects will be treated with current SOC and will also use a kneeMD splint 3 times a day for 20 minutes per session
KneeMD is a subject-controlled knee rehabilita¬tion device that helps subjects who have undergone total knee replacements or other major knee surger¬ies improve range of motion and stretch in extension.
- AROM [ Time Frame: 4 weeks after randomization ]Change in maximal active range of motion in
- AROM [ Time Frame: 2 weeks postoperatively ]Active Range of motion in degrees
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638480
|United States, Maryland|
|Anne Arundel Medical Center|
|Annapolis, Maryland, United States, 21401|