The Use of Bone Growth Stimulators for Osteoarthritis of... | NCT03476382

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

NCT03476382

Sponsor

Coastal Carolinas Integrated Medicine

Status

Completed

Last Update Posted

Jan 31, 2019Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Osteo Arthritis Knee

Interventions

Ultrasound Bone Growth Stimulator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 9, 2018Actual

Primary Completion Date

Nov 15, 2018Actual

Completion Date

Nov 15, 2018Actual

First Submitted Date

Mar 18, 2018

First Submission Date that Met QC Criteria

Mar 19, 2018

First Posted Date

Mar 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2019

Last Update Posted Date

Jan 31, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group	Experimental	Participants use active Ultrasound Bone Growth Stimulator device according to Investigational Protocol.	Device: Ultrasound Bone Growth Stimulator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound Bone Growth Stimulator	Device	Active device emits ultrasound signals.	Experimental Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth Willeford, MD	Coastal Carolinas Integrated Medicine	Study Chair
Sierra Willeford	Coastal Carolinas Integrated Medicine	Principal Investigator
Breanna Willeford	Coastal Carolinas Integrated Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Coastal Carolinas Integrated Medicine		Supply	North Carolina	28462	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 13, 2020
Reset	Jul 27, 2020

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D012216	Rheumatic Diseases
D009140	Musculoskeletal Diseases
D007592	Joint Diseases
D001168	Arthritis

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 13, 2020			Jul 27, 2020
Aug 6, 2020