Arthritis of KneeJointNCT02294045
Analysis of Joint Sounds in the Diagnosis of Knee Disorders
An observational study of Arthritis of Knee and Normal Knee, run by Loma Linda University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis of Knee, Normal Knee, Knee Arthroscopy
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2017to 18 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male or female english-speaking from the ages of 18 thru 70
Who may be able to join
- 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.
Who cannot join
- Neurologic Disease
- Previous serious injury (Fracture or dislocation).
- Previous Ligament reconstruction.
- Major non-subtitle problems with their knees. (This would create overwhelming noises).
About this study
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.
Read the 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.
- Conditions
- Arthritis of Knee, Normal Knee, Knee Arthroscopy
- Keywords
- Knee, Healthy, arthroscopy, MRI, amplification, sounds, pre-operative, analyzing
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 -2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study start20 Jan 2017 (estimated)
- Primary completion18 Feb 2018 (estimated)
- Study completion18 May 2018 (estimated)
Why it stopped: Unable to get the correct software.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis of KneeStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294045
- Sponsor's protocol ID
- 5120242
- Acronym
- Joint
- Status last verified
- Jun 2021
- First submitted
- 8 Sep 2014
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Joint Sounds in the Diagnosis of Knee Disorders
- ClinicalTrials.gov ID
- NCT02294045
- Acronym / sponsor ID
- Joint / 5120242
- Conditions
- Arthritis of Knee, Normal Knee, Knee Arthroscopy
- Keywords
- Knee, Healthy, arthroscopy, MRI, amplification, sounds, pre-operative, analyzing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to get the correct software.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 20 Jan 2017 (estimated)
- Primary completion
- 18 Feb 2018 (estimated)
- Study completion
- 18 May 2018 (estimated)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female english-speaking from the ages of 18 thru 70
Key inclusion criteria (6 listed)
- Phase I
- Healthy Individuals.
- No neurological problems.
- No knee complaints.
- No previous Surgery or Knee injuries.
Key exclusion criteria (4 listed)
- Neurologic Disease
- Previous serious injury (Fracture or dislocation).
- Previous Ligament reconstruction.
- Major non-subtitle problems with their knees. (This would create overwhelming noises).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analysis of Joint Sounds in the Diagnosis of Knee Disorders
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- BackgroundLudloff 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis of Knee and Normal Knee, run by Loma Linda University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of Joint Sounds in the Diagnosis of Knee Disorders (time frame: 1 -2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02294045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.