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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02670499

Acronym

GAP-Flex

Enrollment

Registered

2016-02-01

Start date

2015-11-18

Completion date

2017-06-23

Last updated

2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Replacement

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

Interventions

DEVICECPM

Used to aid in recovery from TKR

DEVICEGAPFLEX

Used to aid in the recovery of TKR

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Flexion	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026