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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670499
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Xeras Medical Technologies

Brief Summary:
Post Market TKR study

Condition or disease Intervention/treatment Phase
Total Knee Replacement Device: CPM Device: GAPFLEX Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)
Actual Study Start Date : November 18, 2015
Actual Primary Completion Date : February 7, 2017
Actual Study Completion Date : June 23, 2017

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 Name: Continuous Passive Motion Device




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670499


Locations
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United States, Texas
Nix Orthopaedic Center
San Antonio, Texas, United States, 78205
Orthopaedic Institute
San Antonio, Texas, United States, 78260
Sponsors and Collaborators
Xeras Medical Technologies
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Responsible Party: Xeras Medical Technologies
ClinicalTrials.gov Identifier: NCT02670499    
Other Study ID Numbers: GPF2015-01
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No