Study Comparing GAP-Flex to CPM Therapy in Treatment of TKR | NCT02670499

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

NCT02670499

Sponsor

Xeras Medical Technologies

Status

Completed

Last Update Posted

Jun 27, 2017Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Total Knee Replacement

Interventions

CPM
GAPFLEX

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 18, 2015Actual

Primary Completion Date

Feb 7, 2017Actual

Completion Date

Jun 23, 2017Actual

First Submitted Date

Sep 4, 2015

First Submission Date that Met QC Criteria

Jan 28, 2016

First Posted Date

Feb 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2017

Last Update Posted Date

Jun 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GAP-FLEX	Experimental	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
CPM	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPM	Device	Used to aid in recovery from TKR	CPM	Continuous Passive Motion Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Nix Orthopaedic Center		San Antonio	Texas	78205	United States
Orthopaedic Institute

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided