Study Comparing GAP-Flex to CPM Therapy in Treatment of TKR
GAP-Flex
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)
1 other identifier
interventional
28
1 country
2
Brief Summary
Post Market TKR study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2015
CompletedStudy Start
First participant enrolled
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2017
CompletedJune 27, 2017
June 1, 2017
1.2 years
September 4, 2015
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
GAP-FLEX
EXPERIMENTALStudy 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
CPM
ACTIVE COMPARATORControl 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
Interventions
Eligibility Criteria
You may qualify if:
- Minimum age 50 years
- Subject is undergoing total knee replacement
- Subject agrees to comply with the physical therapy regime
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nix Orthopaedic Center
San Antonio, Texas, 78205, United States
Orthopaedic Institute
San Antonio, Texas, 78260, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2015
First Posted
February 1, 2016
Study Start
November 18, 2015
Primary Completion
February 7, 2017
Study Completion
June 23, 2017
Last Updated
June 27, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share