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

NCT ID: NCT03476382

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2018-11-15

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.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

Participants use active Ultrasound Bone Growth Stimulator device according to Investigational Protocol.

Group Type: EXPERIMENTAL

Ultrasound Bone Growth Stimulator

Intervention Type: DEVICE

Active device emits ultrasound signals.

Interventions

Ultrasound Bone Growth Stimulator

Active device emits ultrasound signals.

Intervention Type: DEVICE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coastal Carolinas Integrated Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Willeford, MD

Role: STUDY_CHAIR

Coastal Carolinas Integrated Medicine

Sierra Willeford

Role: PRINCIPAL_INVESTIGATOR

Coastal Carolinas Integrated Medicine

Breanna Willeford

Role: PRINCIPAL_INVESTIGATOR

Coastal Carolinas Integrated Medicine

Locations

Coastal Carolinas Integrated Medicine

Supply, North Carolina, United States

Countries

United States

Other Identifiers

CCIM 0001

Identifier Type: -

Identifier Source: org_study_id