NCT03476382

The Use of Bone Growth Stimulators for Osteoarthritis of the Knee.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Coastal Carolinas Integrated Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The hypothesis of this study is that since osteoarthritis of the knee is primarily a bone disease where the joint changes are secondary, and bone growth stimulators function to decrease intraosseous venous congestion and remodel bone, then there is a potential benefit for the treatment of osteoarthritis of the knee with bone growth stimulators.

Detailed description

The hypothesis of this study is based on the knowledge that osteoarthritis of the knee is primarily a bone disease, and the joint changes are secondary. Bone growth stimulators function to alleviate intraosseous venous congestion through the process of bone remodeling. The working hypothesis is that alleviation of intraosseous venous congestion leads to improved delivery of nutrition to the tissue to support the health of the bone with improvement in biomechanics leading to clinical improvement. Venous congestion is measured with intraosseous pressure. Additional objective evidence of biomarkers of bone metabolism as well as measurements of subjective questionnaires can provide evidence of benefit.

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
DEVICE	Ultrasound Bone Growth Stimulator	Active device emits ultrasound signals.

Timeline

• Start date: 2018-04-09
• Primary completion: 2018-11-15
• Completion: 2018-11-15
• First posted: 2018-03-26
• Last updated: 2019-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study