Status:
COMPLETED
The Use of Bone Growth Stimulators for Osteoarthritis of the Knee.
Lead Sponsor:
Coastal Carolinas Integrated Medicine
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
Phase:
NA
Brief 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 v...
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03476382
Start Date
April 9 2018
End Date
November 15 2018
Last Update
January 31 2019
Active Locations (1)
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1
Coastal Carolinas Integrated Medicine
Supply, North Carolina, United States, 28462