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CompletedNCT03476382Updated Jan 31, 2019

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

An interventional study of Ultrasound Bone Growth Stimulator in Osteo Arthritis Knee, sponsored by Coastal Carolinas Integrated Medicine. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-01-31.

Sponsored by Coastal Carolinas Integrated Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteo Arthritis Knee

Keywords

  • Osteoarthritis
  • Knee
  • Bone Growth Stimulators
  • Rheumatic Diseases
  • Musculoskeletal Diseases
  • Joint Diseases
  • Arthritis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Experimental Group

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

    Device: Ultrasound Bone Growth Stimulator

Interventions

  • DeviceUltrasound Bone Growth Stimulator

    Active device emits ultrasound signals.

05

What researchers measure

Primary outcomes

  1. Intraosseous Venous Congestion measured by Intraossous Pressure.

    Statistically significant decrease in intraosseous pressure following treatment.

    Time frame: 14 weeks

Secondary outcomes

  1. Human Matrix Metalloproteinase-3 (MMP-3)

    Statistically significant decrease in the biomarker MMP-3

    Time frame: 14 weeks

  2. C- telopeptide.

    Statistically significant decrease in the biomarker C- telopeptide.

    Time frame: 14 weeks

  3. 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.

    Time frame: 14 weeks

06

Study locations

1 site
  • Coastal Carolinas Integrated Medicine
    Supply, North Carolina 28462, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03476382
Lead sponsor
Coastal Carolinas Integrated Medicine
Responsible party
Sponsor
First posted
Mar 26, 2018
Start date
Apr 9, 2018
Primary completion
Nov 15, 2018
Completion
Nov 15, 2018
Last update
Jan 31, 2019

Study contacts

Kenneth Willeford, MD
study chair · Coastal Carolinas Integrated Medicine
Sierra Willeford
principal investigator · Coastal Carolinas Integrated Medicine
Breanna Willeford
principal investigator · Coastal Carolinas Integrated Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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