Study Comparing GAP-Flex to CPM Therapy in Treatment of TKR

Study Overview
=================
Brief Summary
-----------------
Post Market TKR study

Detailed Description
-----------------
A post-market study to evaluate the safety and effectiveness of the GAP-FLEX device in combination with standard of care physical therapy compared to the standard of care CPM device in combination with standard of care physical therapy in Subjects who have undergone TKR

Official Title
-----------------
A Randomized Controlled Multicenter Study Comparing GAP-FLEX to Continuous Passive Motion (CPM) Therapy in Combination With Standard of Care Physical Therapy in Subjects With Total Knee Replacement (TKR)

Conditions
-----------------
Total Knee Replacement

Intervention / Treatment
-----------------
* Device: CPM
* Device: GAPFLEX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age 50 years Subject is undergoing total knee replacement Subject agrees to comply with the physical therapy regime Exclusion Criteria: With a flexure contracture > 10 degrees Degree of flexion < 60 degrees pre-procedure or immediately post-procedure Severe motion restriction as determined by the investigator Severe deformity determined by the investigator Taking chronic pain medication for use other than knee pain Post surgery hospital stay is > 4 days Knee disorders other than osteoarthritis With fibromyalgia Chronic narcotic use as determined by the investigator. Have a medical or psychological history that in the opinion of the investigator would make the subject a poor candidate for the study. Who need a revision implant Who have participated in clinical study within the past 30 days (prior to enrollment) that may affect the outcome of this study Amputations below or above knee of non-operated leg Weight is >250 pounds and/or morbidly obese (BMI > 40) History of blood clots Deep vein thrombosis Females who are pregnant Females who wish to become pregnant during the length of study participation Subjects with any of the following post-surgery conditions; Screws needed Intraoperative identification of a fracture or soft bone Admitted to ICU Additional procedures (other than TKR) needed for other identified or pre-existing conditions

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GAP-FLEX<br>Study Device will be used up to 6 times per day for up to 6 minutes to aid in the recovery and improve the degree of flexion from TKR | Device: GAPFLEX<br>* Used to aid in the recovery of TKR<br>|
| Active Comparator: CPM<br>Control Device will be used up to 2 hours per day for up to 3 times per day to aid in the recovery and improve the degree of flexion from TKR and be compared to the Study Device | Device: CPM<br>* Used to aid in recovery from TKR<br>* Other names: Continuous Passive Motion Device;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flexion | improvement in week 4 visit degree of flexion measured by Goniometer in the GAP-FLEX group will be compared to the CPM | Degree of flexion achieved at week 4 visit |