Cartilage DiseasesNCT01006278
Molecular Biomarkers Associated With Degenerative Joint Disease in the Knee
An observational study of Cartilage Diseases, run by Scuderi, Gaetano J., M.D..
Trial summary
This investigation describes a novel complex of structural degradation proteins that is associated with pain in individuals with meniscal pathology undergoing arthroscopic partial meniscectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cartilage Diseases
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Mar 2009
- 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: The operative group consisted of patients 18 years of age or greater with a history of knee pain for more than three but less than six months who failed conservative management including NSAIDs, physical therapy, and activity modification.
Who may be able to join
- the presence of mechanical symptoms including locking, catching, or giving way;
- positive physical exam findings including joint line tenderness, McMurray's exam, or Steinman's exam; and
- MRI of the knee positive for meniscus tear in a location correlating with physical examination.
Who cannot join
- the presence of high grade gonarthrosis including Kellgren-Lawrence grade IV;
- a history of prior knee surgery or trauma; ligamentous incompetence on examination or MRI; and
- diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases.
About this study
Official title: Molecular Biomarkers Associated With Degenerative Joint Disease
This investigation describes a novel complex of structural degradation proteins that is associated with pain in individuals with meniscal pathology undergoing arthroscopic partial meniscectomy. The presence of the complex in the synovial fluid of the knee is sensitive and specific for the painful state compared with similar aged controls. The absence of the complex in asymptomatic controls makes it a useful biomarker for the disease state.
Read the detailed description
Background: Molecular biomarkers associated with knee pain may be useful as diagnostic tools, prognostic indicators, and surrogate endpoints for therapeutic trials. This study describes a novel complex of structural degradation proteins which are present in the knees of patients with meniscal pathology.
Methods: This prospective cohort study included 30 patients with knee pain, mechanical symptoms, and MRI positive for meniscus tear who elected for arthroscopic partial meniscectomy after failing conservative management. Synovial fluid was aspirated at the time of surgery and assayed for a complex of structural degradation proteins by means of heterogeneous ELISA. The results were compared to knee aspirates from 10 asymptomatic volunteers with no pain. The complex was identified by a proteomic analysis of including multiplexed-bead immunoassay, purification by anion exchange and size exclusion chromatography, and mass spectrometry of individual chromatographic fractions.
- Conditions
- Cartilage Diseases
- Keywords
- biomarker, knee arthroscopy, pain
- Medical subject headings
- Cartilage Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group with knee pain | patients 18 years of age or greater with a history of knee pain for more than three but less than six months who failed conservative management with the presence of mechanical symptoms including locking, catching, or giving way; positive physical exam findings including joint line tenderness, McMurray's exam, or Steinman's exam; and MRI of the knee positive for meniscus tear in a location correlating with physical examination. Exclusion criteria were as follows: the presence of high grade gonarthrosis including Kellgren-Lawrence grade IV; a history of prior knee surgery or trauma; ligamentous incompetence on examination or MRI; and diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases. | |
| Group 2 | volunteer group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scuderi, Gaetano J., M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Investigators
- Gaetano J Scuderi, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006278
- Sponsor's protocol ID
- Cyt.002
- Status last verified
- Oct 2009
- First submitted
- 30 Oct 2009
- Last updated
- 2 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Biomarkers Associated With Degenerative Joint Disease
- ClinicalTrials.gov ID
- NCT01006278
- Acronym / sponsor ID
- Cyt.002
- Conditions
- Cartilage Diseases
- Keywords
- biomarker, knee arthroscopy, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Scuderi, Gaetano J., M.D.University, hospital or other
- Collaborators
- Stanford University
- Study start
- Jan 2008
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Nov 2009 (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.
This investigation describes a novel complex of structural degradation proteins that is associated with pain in individuals with meniscal pathology undergoing arthroscopic partial meniscectomy. The presence of the complex in the synovial fluid of the knee is sensitive and specific for the painful state compared with similar aged controls. The absence of the complex in asymptomatic controls makes it a useful biomarker for the disease state.
Detailed description
Background: Molecular biomarkers associated with knee pain may be useful as diagnostic tools, prognostic indicators, and surrogate endpoints for therapeutic trials. This study describes a novel complex of structural degradation proteins which are present in the knees of patients with meniscal pathology.
Methods: This prospective cohort study included 30 patients with knee pain, mechanical symptoms, and MRI positive for meniscus tear who elected for arthroscopic partial meniscectomy after failing conservative management. Synovial fluid was aspirated at the time of surgery and assayed for a complex of structural degradation proteins by means of heterogeneous ELISA. The results were compared to knee aspirates from 10 asymptomatic volunteers with no pain. The complex was identified by a proteomic analysis of including multiplexed-bead immunoassay, purification by anion exchange and size exclusion chromatography, and mass spectrometry of individual chromatographic fractions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical group with knee pain | – | –patients 18 years of age or greater with a history of knee pain for more than three but less than six months who failed conservative management with the presence of mechanical symptoms including locking, catching, or giving way; positive physical exam findings including joint line tenderness, McMurray's exam, or Steinman's exam; and MRI of the knee positive for meniscus tear in a location correlating with physical examination. Exclusion criteria were as follows: the presence of high grade gonarthrosis including Kellgren-Lawrence grade IV; a history of prior knee surgery or trauma; ligamentous incompetence on examination or MRI; and diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases. |
| Group 2 | – | –volunteer group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The operative group consisted of patients 18 years of age or greater with a history of knee pain for more than three but less than six months who failed conservative management including NSAIDs, physical therapy, and activity modification.
Key inclusion criteria (3 listed)
- the presence of mechanical symptoms including locking, catching, or giving way;
- positive physical exam findings including joint line tenderness, McMurray's exam, or Steinman's exam; and
- MRI of the knee positive for meniscus tear in a location correlating with physical examination.
Key exclusion criteria (3 listed)
- the presence of high grade gonarthrosis including Kellgren-Lawrence grade IV;
- a history of prior knee surgery or trauma; ligamentous incompetence on examination or MRI; and
- diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2009.
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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.
Gaetano J Scuderi, MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Diseases, run by Scuderi, Gaetano J., M.D..
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Nov 2009. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 2 Nov 2009.