NCT02670499
Completed
Not Applicable
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)
Xeras Medical Technologies2 sites in 1 country28 target enrollmentStarted: November 18, 2015Last updated:
ConditionsTotal Knee Replacement
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Xeras Medical Technologies
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Flexion
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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