Study Comparing GAP-Flex to CPM Therapy in Treatment of TKR
Completed · Not applicable
Conditions studied: Total Knee Replacement
In brief
Post Market TKR study
Key facts
- Study ID
- NCT02670499
- Run by
- Xeras Medical Technologies
- People needed
- 28
- Starts
- 2015-11-18
- Expected to finish
- 2017-06-23
- Last updated by the study team
- 2017-06-27
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
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
- 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
Where it is running
- Nix Orthopaedic Center — San Antonio, Texas, United States
- Orthopaedic Institute — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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