The Use of Bone Growth Stimulators for Osteoarthritis of the Knee.
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/2/2019 |
| Start Date: | April 9, 2018 |
| End Date: | November 15, 2018 |
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.
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.
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.
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.
Inclusion Criteria:
1. Subjects must have diagnosis of osteoarthritis of the knee with radiographic evidence
of joint space narrowing, Kellgren-Lawrence Classification grade Grade 3 or 4.
2. Subjects must discontinue corticosteroids administered by any route except intranasal
spray, steroid- containing ophthalmic solutions and anti-asthmatics.
3. Subjects must speak English.
4. Subject must be willing and able to sign an informed consent document.
5. Subjects must be willing and able to comply with all study procedures for the duration
of the clinical study.
Exclusion Criteria:
1. Subjects with a diagnosis of inflammatory arthritis such as rheumatoid arthritis,
gout, joint infection, Lyme disease, or systemic lupus erythematosus.
2. Subjects with a diagnosis of secondary arthritis such as acromegaly, Charcot's
arthropathy, hemochromatosis, or Wilson's disease.
3. Subjects who have had an injury to the index knee within 6 months of starting
treatment.
4. Subjects must NOT have had arthroscopy within 8 weeks of starting treatment.
5. Subjects must NOT have had viscosupplementation within 8 weeks of starting treatment.
6. Subjects who plan to have surgery on the target knee within the study period.
7. Subjects with surgical metallic hardware in the target knee.
8. Subjects who are unwilling or unable to adhere to the follow up schedule and
procedures.
9. Subjects who are pregnant.
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