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

Completed · Not applicable

Conditions studied: Osteo Arthritis Knee

In brief

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.

Key facts

Study ID

NCT03476382

Run by

Coastal Carolinas Integrated Medicine

People needed

20

Starts

2018-04-09

Expected to finish

2018-11-15

Last updated by the study team

2019-01-31

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must have diagnosis of osteoarthritis of the knee with radiographic evidence of joint space narrowing, Kellgren-Lawrence Classification grade Grade 3 or 4.
• Subjects must discontinue corticosteroids administered by any route except intranasal spray, steroid- containing ophthalmic solutions and anti-asthmatics.
• Subjects must speak English.
• Subject must be willing and able to sign an informed consent document.
• Subjects must be willing and able to comply with all study procedures for the duration of the clinical study.

You may not qualify if…

• Subjects with a diagnosis of inflammatory arthritis such as rheumatoid arthritis, gout, joint infection, Lyme disease, or systemic lupus erythematosus.
• Subjects with a diagnosis of secondary arthritis such as acromegaly, Charcot's arthropathy, hemochromatosis, or Wilson's disease.
• Subjects who have had an injury to the index knee within 6 months of starting treatment.
• Subjects must NOT have had arthroscopy within 8 weeks of starting treatment.
• Subjects must NOT have had viscosupplementation within 8 weeks of starting treatment.
• Subjects who plan to have surgery on the target knee within the study period.
• Subjects with surgical metallic hardware in the target knee.
• Subjects who are unwilling or unable to adhere to the follow up schedule and procedures.
• Subjects who are pregnant.

Where it is running

• Coastal Carolinas Integrated Medicine — Supply, North Carolina, United States

Full record on ClinicalTrials.gov

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