Analysis of Joint Sounds in the Diagnosis of Knee Disorders (Joint)

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.

Study Overview

• Status: Withdrawn
• Conditions: Knee Arthroscopy; Arthritis of Knee; Normal Knee

Detailed 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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Loma Linda University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 20, 2017
• Primary Completion (Anticipated): February 18, 2018
• Study Completion (Anticipated): May 18, 2018

Study Registration Dates

• First Submitted: September 8, 2014
• First Submitted That Met QC Criteria: November 14, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: MRI; Healthy; Knee; arthroscopy; pre-operative; amplification; sounds; analyzing
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 5120242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No