Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Flexion Contracture

Intervention / Treatment
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* Device: KneeMD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Measurable Knee Flexion Contracture, with deficit limiting Active Range of Motion (AROM) and Passive Range of Motion (PROM) by at least - 10° 18 years of age and older Able to understand informed consent and willingness to conform to trial responsibilities Exclusion Criteria: Previous surgical treatment of knee, including tibial osteotomy Botulinum Toxin Treatment within the last four months Mechanical joint impingement Neuromuscular pathologies such as epilepsy Treatment with quinolone, antibiotic medication Pregnant or nursing Fractures Osteomyelitis or any orthopedic infection Extensor mechanism dysfunction Knee joint neuropathy Previous Stroke or Brain Injury

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control subjects will be treated with only the current SOC including NSAIDs and physical therapy. | |
| Experimental: Experimental<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AROM | Change in maximal active range of motion in | 4 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AROM | Active Range of motion in degrees | 2 weeks postoperatively |