NCT02294045

Brief Summary

Clinical-noninvasive recording of sounds from the knees through a brief loaded range of motion. Description in phase 1 analytic but descriptive as well in phase 2. No samples other than a sound recording. The device is known microphone attached to the skin of the knee with elastic material. Sound recorded and analyzed on a lap top computer with Adobe software.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 20, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2018

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

September 8, 2014

Last Update Submit

June 1, 2021

Conditions

Keywords

KneeHealthyarthroscopyMRIamplificationsoundspre-operativeanalyzing

Outcome Measures

Primary Outcomes (1)

  • Analysis of Joint Sounds in the Diagnosis of Knee Disorders

    Phase 1: Analysis will be carried out on the recording from apparently normal knees, sounds are amplification, wave form and filtering. Effects of age, height and weight. Phase 2: analysis of sound will br carried out by a researcher blinded to the MRI and arthroscopic pathology, Then, comparison of the abnormal sounds to the pathology found on the MRI and Arthroscopy to look for correlations.

    1 -2 years

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male or female english-speaking from the ages of 18 thru 70

You may qualify if:

  • Phase I
  • Healthy Individuals.
  • No neurological problems.
  • No knee complaints.
  • No previous Surgery or Knee injuries.

You may not qualify if:

  • Neurologic Disease
  • Previous serious injury (Fracture or dislocation).
  • Previous Ligament reconstruction.
  • Major non-subtitle problems with their knees. (This would create overwhelming noises).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ludloff D. ie Auskultation der Wirbelsäule, des Kreuzbeins und des Reckens. Münchener medizinische wochenschrift, LIII, 1197, 1906. Walters CF. The Value of Joint Auscultation. In: The Lancet, 1:920-921. 1929. Rangayyan RM, Wu YF. Screening of Knee-Joint Vibroarthrographic Signals Using Statistical Parameters and Radial Basis Functions. In: Medical & Biological Engineering & Computing 46 (3) 2008: pp. 223-232. Chu ML, Gradisar IA, Zavodney LD. Possible Clinical Application of a Noninvasive Monitoring Technique of Cartilage Damage in Pathological Knee Joints. In: Journal of Clinical Engineering 3 (1), 1978: pp. 19-27. McCoy GF, McCrea JD, Beverland DE, Kernohan WG, Mollan RAB. Vibration Arthrography as a Diagnostic Aid in Diseases of the Knee. In: The Journal of Bone and Joint Surgery 69-B (2), 1987: pp. 288-293. Reddy NP, Rothschild BM, Mandal, M, Gupta V, Suryanarayanan S. Noninvasive Acceleration Measurements to Characterize Knee Arthritis and Chondromalacia. In: Annals of Biomedical Engineering, v. 23, pp. 78-84, 1995. Krishnan S, Rangayyan RM, Bell GD, Frank CB, and Ladly KO. Adaptive Filtering, Modeling, and Classification of Knee Joint Vibroarthrographic Signals for Noninvasive Diagnosis of Articular Cartilage Pathology. In: Medical and Biological Engineering and Computing, 35(6):677-684, 1997.

    BACKGROUND
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2014

First Posted

November 19, 2014

Study Start

January 20, 2017

Primary Completion

February 18, 2018

Study Completion

May 18, 2018

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share