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

Xeras Medical Technologies

Status: Completed

Conditions: Total Knee Replacement

Treatments: Device: CPM; Device: GAPFLEX

Study type: Interventional

Funder types: Industry

Identifiers

NCT02670499

GPF2015-01

Details and patient eligibility

About

Post Market TKR study

Full 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

Enrollment: 28 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

GAP-FLEX

Experimental group

Description:

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

Treatment:

Device: GAPFLEX

CPM

Active Comparator group

Description:

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

Treatment:

Device: CPM