Osteoarthritis, KneeNCT00504114
MR Imaging of Knee Osteoarthritis and Acute Knee Injuries
An observational study of Osteoarthritis, Knee, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to use better magnetic resonance imaging (MRI) techniques to examine the knee and the bony and soft tissue changes so as to better predict the progression of osteoarthritis and acute knee injuries. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- ACL Reconstruction Surgery, Cartilage Resurfacing Surgery and Total Knee Replacement
- Type of treatment
- Surgery or procedure
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment flyers are posted at different UCSF campuses and those staff and students. Patient eligibility will determined initially bye the referring orthopedist.
Who may be able to join
- Healthy volunteers will have had no previous knee symptoms or surgery
- Patients with mild arthritic symptoms and Kellgren Lawrence score of 2
- Patients with severe arthritic symptoms and Kellgren Lawrence score of 3, or 4
- Patients with acute ACL injury with associated bone contusion and bone edema
- Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures
- Patient is willing to participate in the proposed study as evidenced by providing written informed consent.
Who cannot join
- Current use of an investigational drug
- Conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy or a stroke.)
- Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco; MR Surbeck Laboratory of Advanced Imaging
San Francisco, California, 94158
About this study
The purpose of this study is to use better magnetic resonance imaging (MRI) techniques to examine the knee and the bony and soft tissue changes so as to better predict the progression of osteoarthritis and acute knee injuries.
Read the detailed description
The study will examine the pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes; and evaluate T1p relaxation methods and its' relating to cartilage loss. The protocol is geared towards sequences utilizing 3 Tesla magnetic resonance imaging (MRI) that will enable the measures of cartilage volume and T2. Measures cartilage volume and T2 are more established MR methods for studying osteoarthritis (OA).
All OA and Anterior cruciate ligament (ACL) subjects will undergo MR imaging of the knee joint at 3 Tesla at baseline,, and three annual follow up time points. Regions of interest will include the total tibial and femoral cartilage, and sub-division such as the medial and lateral compartments of the tibial and femoral cartilage to account for localized disease activity and progression.
Bone marrow edema size, MR spectroscopy based marrow fat/water content, and trabecular bone microarchitecture underlying the edema will be measured in the OA and ACL groups to determine whether there is any distinction between these measures in OA and in traumatic ACL injury, cross-sectionally and longitudinally, and their relation to cartilage loss and OA progression.
- Conditions
- Osteoarthritis, Knee
- Being tested
- ACL Reconstruction Surgery, Cartilage Resurfacing Surgery, Total Knee Replacement
- Keywords
- Osteoarthritis, knee, anterior cruciate ligament, Magnetic Resonance Imaging
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL Reconstruction SurgeryProcedure or surgery
Cartilage Resurfacing SurgeryProcedure or surgery
Total Knee ReplacementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Healthy volunteers without knee pain. | |
| 2 | Patients with mild arthritic symptoms and radiographic changes (Kellgren Lawrence score of 1, 2) | |
| 3 | Patients with severe pain and functional limitations associated with knee arthritis (Kellgren Lawrence score of 3, 4). Receives: Procedure: Total Knee Replacement | |
| 4 | Patients with acute anterior cruciate ligament (ACL) injuries with associated osseous contusion. Receives: Procedure: ACL Reconstruction Surgery | |
| 5 | Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures. Receives: Procedure: Cartilage Resurfacing Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes
Measured: Baseline, 1 year, 2 year, 3 year
Secondary outcomes (1)
Evaluate T1rho relaxation methods and its' relation to cartilage loss
Measured: Baseline, 1 year, 2 year, 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startAug 2006
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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-control
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Sharmila Majumdar, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504114
- Sponsor's protocol ID
- 2R01AR046905
- Status last verified
- Dec 2013
- First submitted
- 17 Jul 2007
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Imaging of Knee Osteoarthritis and Acute Knee Injuries
- ClinicalTrials.gov ID
- NCT00504114
- Acronym / sponsor ID
- 2R01AR046905
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, knee, anterior cruciate ligament, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2006
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Jul 2007 (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.
The purpose of this study is to use better magnetic resonance imaging (MRI) techniques to examine the knee and the bony and soft tissue changes so as to better predict the progression of osteoarthritis and acute knee injuries.
Detailed description
The study will examine the pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes; and evaluate T1p relaxation methods and its' relating to cartilage loss. The protocol is geared towards sequences utilizing 3 Tesla magnetic resonance imaging (MRI) that will enable the measures of cartilage volume and T2. Measures cartilage volume and T2 are more established MR methods for studying osteoarthritis (OA).
All OA and Anterior cruciate ligament (ACL) subjects will undergo MR imaging of the knee joint at 3 Tesla at baseline,, and three annual follow up time points. Regions of interest will include the total tibial and femoral cartilage, and sub-division such as the medial and lateral compartments of the tibial and femoral cartilage to account for localized disease activity and progression.
Bone marrow edema size, MR spectroscopy based marrow fat/water content, and trabecular bone microarchitecture underlying the edema will be measured in the OA and ACL groups to determine whether there is any distinction between these measures in OA and in traumatic ACL injury, cross-sectionally and longitudinally, and their relation to cartilage loss and OA progression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy volunteers without knee pain. |
| 2 | – | –Patients with mild arthritic symptoms and radiographic changes (Kellgren Lawrence score of 1, 2) |
| 3 | – | Procedure: Total Knee ReplacementPatients with severe pain and functional limitations associated with knee arthritis (Kellgren Lawrence score of 3, 4). |
| 4 | – | Procedure: ACL Reconstruction SurgeryPatients with acute anterior cruciate ligament (ACL) injuries with associated osseous contusion. |
| 5 | – | Procedure: Cartilage Resurfacing SurgeryPatients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment flyers are posted at different UCSF campuses and those staff and students. Patient eligibility will determined initially bye the referring orthopedist.
Key inclusion criteria (6 listed)
- Healthy volunteers will have had no previous knee symptoms or surgery
- Patients with mild arthritic symptoms and Kellgren Lawrence score of 2
- Patients with severe arthritic symptoms and Kellgren Lawrence score of 3, or 4
- Patients with acute ACL injury with associated bone contusion and bone edema
- Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures
Key exclusion criteria (3 listed)
- Current use of an investigational drug
- Conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy or a stroke.)
- Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL Reconstruction Surgery | Procedure or surgery | 4 |
| Cartilage Resurfacing Surgery | Procedure or surgery | 5 |
| Total Knee Replacement | Procedure or surgery | 3 |
Primary outcome
Pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes
Time frame: Baseline, 1 year, 2 year, 3 year
1 secondary outcome
Evaluate T1rho relaxation methods and its' relation to cartilage loss
Time frame: Baseline, 1 year, 2 year, 3 year
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 12 Dec 2013.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Sharmila Majumdar, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by University of California, San Francisco at 1 site in United States.
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 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 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes (time frame: Baseline, 1 year, 2 year, 3 year). It is what the study was designed to measure, not a finding.
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 12 Dec 2013.