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

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound Bone Growth Stimulator
Sponsored by
Coastal Carolinas Integrated Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Osteoarthritis, Knee, Bone Growth Stimulators, Rheumatic Diseases, Musculoskeletal Diseases, Joint Diseases, Arthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Coastal Carolinas Integrated Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

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

Outcomes

Primary Outcome Measures

Intraosseous Venous Congestion measured by Intraossous Pressure.
Statistically significant decrease in intraosseous pressure following treatment.

Secondary Outcome Measures

Human Matrix Metalloproteinase-3 (MMP-3)
Statistically significant decrease in the biomarker MMP-3
C- telopeptide.
Statistically significant decrease in the biomarker C- telopeptide.
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.

Full Information

First Posted
March 18, 2018
Last Updated
January 29, 2019
Sponsor
Coastal Carolinas Integrated Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03476382
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
November 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coastal Carolinas Integrated Medicine

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Osteoarthritis, Knee, Bone Growth Stimulators, Rheumatic Diseases, Musculoskeletal Diseases, Joint Diseases, Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Participants use active Ultrasound Bone Growth Stimulator device according to Investigational Protocol.
Intervention Type
Device
Intervention Name(s)
Ultrasound Bone Growth Stimulator
Intervention Description
Active device emits ultrasound signals.
Primary Outcome Measure Information:
Title
Intraosseous Venous Congestion measured by Intraossous Pressure.
Description
Statistically significant decrease in intraosseous pressure following treatment.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Human Matrix Metalloproteinase-3 (MMP-3)
Description
Statistically significant decrease in the biomarker MMP-3
Time Frame
14 weeks
Title
C- telopeptide.
Description
Statistically significant decrease in the biomarker C- telopeptide.
Time Frame
14 weeks
Title
Change over time in WOMAC score.
Description
The primary outcome variables are a statistically significant improvement in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores.
Time Frame
14 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must have diagnosis of osteoarthritis of the knee with radiographic evidence of joint space narrowing, Kellgren-Lawrence Classification grade Grade 3 or 4. Subjects must discontinue corticosteroids administered by any route except intranasal spray, steroid- containing ophthalmic solutions and anti-asthmatics. Subjects must speak English. Subject must be willing and able to sign an informed consent document. Subjects must be willing and able to comply with all study procedures for the duration of the clinical study. Exclusion Criteria: Subjects with a diagnosis of inflammatory arthritis such as rheumatoid arthritis, gout, joint infection, Lyme disease, or systemic lupus erythematosus. Subjects with a diagnosis of secondary arthritis such as acromegaly, Charcot's arthropathy, hemochromatosis, or Wilson's disease. Subjects who have had an injury to the index knee within 6 months of starting treatment. Subjects must NOT have had arthroscopy within 8 weeks of starting treatment. Subjects must NOT have had viscosupplementation within 8 weeks of starting treatment. Subjects who plan to have surgery on the target knee within the study period. Subjects with surgical metallic hardware in the target knee. Subjects who are unwilling or unable to adhere to the follow up schedule and procedures. Subjects who are pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Willeford, MD
Organizational Affiliation
Coastal Carolinas Integrated Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sierra Willeford
Organizational Affiliation
Coastal Carolinas Integrated Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Breanna Willeford
Organizational Affiliation
Coastal Carolinas Integrated Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coastal Carolinas Integrated Medicine
City
Supply
State/Province
North Carolina
ZIP/Postal Code
28462
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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