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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02294045
Other study ID # 5120242
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 20, 2017
Est. completion date May 18, 2018

Study information

Verified date June 2021
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

There is a need for a less expensive and more universally available screening device for the knee, and other joint pathology. The equipment used for ultrasound is much less expensive and cumbersome than that of an x-ray or magnetic resonance imaging. The equipment we will use for the analysis of sound produced by the body itself is an order of magnitude less expensive than ultrasound; such as a laptop computer with currently available software and an inexpensive transducer. Analysis of sound has proved useful in Pulmonology and Cardiology. We believe sound analysis will provide a useful yet inexpensive tool for primary care physicians as well as musculoskeletal specialists. Phase 1: Establish the normal sound patterns emanating from the uninjured knee; we will look for the influence of age, height and weight. Phase 2: To record and analyze the preoperative sound patterns from the knees with pathology, known by MRI and arthroscopy, then compare them with the normal sounds from Phase 1.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 18, 2018
Est. primary completion date February 18, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: Phase I - Healthy Individuals. - No neurological problems. - No knee complaints. - No previous Surgery or Knee injuries. Phase II Patients undergoing knee arthroscopy who have pre-op MRI. The inclusion will be based on age group, 20 years of age, 40 and 60. Exclusion Criteria: - Neurologic Disease - Previous serious injury (Fracture or dislocation). - Previous Ligament reconstruction. - Major non-subtitle problems with their knees. (This would create overwhelming noises).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

References & 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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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