Analysis of Joint Sounds in the Diagnosis of Knee Disorders

Withdrawn

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

• Registration Number: NCT02294045
• Lead Sponsor: Loma Linda University

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.

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 Timeline

• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-19
• Study Start: 2017-01-20
• Primary Completion: 2018-02-18
• Study Completion: 2018-05-18
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of Joint Sounds in the Diagnosis of Knee Disorders	1 -2 years	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.