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

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.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Device: Ultrasound Bone Growth Stimulator

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Supply, North Carolina, United States, 28462
      • Coastal Carolinas Integrated Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Participants use active Ultrasound Bone Growth Stimulator device according to Investigational Protocol.	Device: Ultrasound Bone Growth Stimulator; Active device emits ultrasound signals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraosseous Venous Congestion measured by Intraossous Pressure.	Statistically significant decrease in intraosseous pressure following treatment.	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human Matrix Metalloproteinase-3 (MMP-3)	Statistically significant decrease in the biomarker MMP-3	14 weeks
C- telopeptide.	Statistically significant decrease in the biomarker C- telopeptide.	14 weeks
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

Collaborators and Investigators

• Sponsor: Coastal Carolinas Integrated Medicine
• Investigators: Study Chair: Kenneth Willeford, MD, Coastal Carolinas Integrated Medicine; Principal Investigator: Sierra Willeford, Coastal Carolinas Integrated Medicine; Principal Investigator: Breanna Willeford, Coastal Carolinas Integrated Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): November 15, 2018

Study Registration Dates

• First Submitted: March 18, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Arthritis; Osteoarthritis; Knee; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Growth Stimulators
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CCIM 0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No