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

Total Knee Replacement Clinical Trial

— GAP-Flex  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670499
• Other study ID #: GPF2015-01
• Status: Completed
• Phase: N/A
• First received: September 4, 2015
• Last updated: June 26, 2017
• Start date: November 18, 2015
• Est. completion date: June 23, 2017

Study information

• Verified date: June 2017
• Source: Xeras Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post Market TKR study

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 23, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Device:
• CPM
Used to aid in recovery from TKR
• GAPFLEX
Used to aid in the recovery of TKR

Locations

Country	Name	City	State
United States	Nix Orthopaedic Center	San Antonio	Texas
United States	Orthopaedic Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Xeras Medical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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