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

NCT03476382 | Completed FDA Device

• 1 other identifier: CCIM 0001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

Osteoarthritis; Knee; Bone Growth Stimulators; Rheumatic Diseases; Musculoskeletal Diseases; Joint Diseases; Arthritis

Outcome Measures

Primary Outcomes (1)

• Intraosseous Venous Congestion measured by Intraossous Pressure.

  Statistically significant decrease in intraosseous pressure following treatment.

  14 weeks

Secondary Outcomes (3)

• Human Matrix Metalloproteinase-3 (MMP-3)

  14 weeks

• C- telopeptide.

  14 weeks

• Change over time in WOMAC score.

  14 weeks

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Device: Ultrasound Bone Growth Stimulator

Interventions

Ultrasound Bone Growth Stimulator DEVICE

Active device emits ultrasound signals.

Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coastal Carolinas Integrated Medicine: lead

Study Sites (1)

Coastal Carolinas Integrated Medicine

Supply, North Carolina, 28462, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Rheumatic Diseases; Musculoskeletal Diseases; Joint Diseases; Arthritis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: March 26, 2018
• Study Start: April 9, 2018
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)