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

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476382
• Other study ID #: CCIM 0001
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: January 2019
• Source: Coastal Carolinas Integrated Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Ultrasound Bone Growth Stimulator
Active device emits ultrasound signals.

Locations

Country	Name	City	State
United States	Coastal Carolinas Integrated Medicine	Supply	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Coastal Carolinas Integrated Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraosseous Venous Congestion measured by Intraossous Pressure.	Statistically significant decrease in intraosseous pressure following treatment.	14 weeks
Secondary	Human Matrix Metalloproteinase-3 (MMP-3)	Statistically significant decrease in the biomarker MMP-3	14 weeks
Secondary	C- telopeptide.	Statistically significant decrease in the biomarker C- telopeptide.	14 weeks
Secondary	Change over time in WOMAC score.	The primary outcome variables are a statistically significant improvement in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores.	14 weeks