An interventional study of KneeMD in Flexion Contracture, sponsored by Anne Arundel Health System Research Institute. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by Anne Arundel Health System Research Institute · Not applicable, Interventional, and Treatment
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.
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.
151 studies on the registry are indexed under Contracture; 21 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 110 interventional studies indexed under Contracture.
Browse Contracture studies →Anne Arundel Health System Research Institute is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: KneeMD
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
Change in maximal active range of motion in
Time frame: 4 weeks after randomization
AROM
Active Range of motion in degrees
Time frame: 2 weeks postoperatively
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Anne Arundel Health System Research Institute