Clinical trial NCT03476382: The Use of Bone Growth Stimulators for Osteoarthritis of the Knee.
Official title: The Use of Bone Growth Stimulators for Osteoarthritis of the Knee.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Osteoarthritis
Knee
Bone Growth Stimulators
Rheumatic Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Lead sponsor: Coastal Carolinas Integrated Medicine
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraosseous Venous Congestion measured by Intraossous Pressure.
timeFrame: 14 weeks
Secondary outcomes:
measure: Human Matrix Metalloproteinase-3 (MMP-3)
timeFrame: 14 weeks
measure: C- telopeptide.
timeFrame: 14 weeks
measure: Change over time in WOMAC score.
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Supply
country: United States
facility: Coastal Carolinas Integrated Medicine
state: North Carolina
Study officials:
affiliation: Coastal Carolinas Integrated Medicine
name: Kenneth Willeford, MD
role: STUDY_CHAIR
affiliation: Coastal Carolinas Integrated Medicine
name: Sierra Willeford
role: PRINCIPAL_INVESTIGATOR
affiliation: Coastal Carolinas Integrated Medicine
name: Breanna Willeford
role: PRINCIPAL_INVESTIGATOR
References: