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

June 26, 2017 updated by: Xeras Medical Technologies

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)

Post Market TKR study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78205
        • Nix Orthopaedic Center
      • San Antonio, Texas, United States, 78260
        • Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GAP-FLEX
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
Used to aid in the recovery of TKR
Active Comparator: CPM
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
Used to aid in recovery from TKR
Other Names:
  • Continuous Passive Motion Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flexion
Time Frame: Degree of flexion achieved at week 4 visit
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xeras Medical Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2015

Primary Completion (Actual)

February 7, 2017

Study Completion (Actual)

June 23, 2017

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • GPF2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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