Degenerative Joint DiseaseNCT01403207
An Analysis of Potential Sex Differences in Knee Osteoarthritis
An observational study of Degenerative Joint Disease and Osteoarthritis, run by Mary O'Connor at 1 site in United States.
Trial summary
This pilot study will use tissues and fluids that are normally discarded during the course of total knee replacement surgery to investigate potential sex differences in knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Joint Disease, Osteoarthritis
- What is being tested?
- musculoskeletal
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Mar 2014
- 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 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patient enrollment will consist of 10 females and 10 male patients stratified by age. Enrollment is anticipated to be completed over a 12 month time period. Only non Hispanic White patients will be included in the study. Patients must be between 65 and 75 years of age. Patients with a BMI greater than 30 will be excluded
Who may be able to join
- 1. Patient demographics (age, sex, BMI). 2. Clinical background material
- Post menopausal female
- List of all medications and supplements
- Use of vitamin D supplements (duration and amount)
- Use of bisphosphonates (past and current)
- Use of estrogen (past and current)
Show all 19Show fewer
- Prior trauma or knee surgery
- Have you ever injured the operative knee so badly that it was difficult for you to walk for at least one week?
- Have you ever had any kind of knee surgery? Please include arthroscopy (where they put a scope in your knee), ligament repair surgery, or a meniscectomy (where they repaired or cut away a torn meniscus or cartilage)?
- Prior intraarticular injections
- Steroid
- Hyaluronic acid
- SF 12
- WOMAC
- PASE functional scale
- Pain scale: The 11 question OARSI-OMERACT pain scale will be used. Patients will complete the pain scale within 2 weeks prior to surgery and at 3 months following surgery
- Knee pain map: Patients will complete this within 2 weeks prior to surgery and at 3 months following surgery
- Pressure pain thresholds at knee. This will be completed within 2 weeks prior to the surgery and at 3 months following surgery (see attachment for details) 3. Preoperative blood tests
- Vitamin D level 25 D3 should be measured 4. Standard preoperative radiographs: AP, lateral, standing flexion AP and patellar sunrise
Who cannot join
- Patients with inflammatory arthritis
- Patients with osteonecrosis
- Patients with prior upper tibial osteotomy
- Premenopausal women
- Patients under age 65 years, older than 75 years
- Patients who are insulin dependent or diabetic
- Patients with a BMI>30
- Patients with a history of knee infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
About this study
This pilot study will use tissues and fluids that are normally discarded during the course of total knee replacement surgery to investigate potential sex differences in knee osteoarthritis. Basic clinical demographic information will be obtained as well as preoperative functional and pain assessment scores, functional tests, and pressure pain threshold measurement. The purpose of the study will be to investigate if any sex differences can be identified in these tissues and to investigate if there appears to be any relationship between these differences and functional scores and tests.
Read the detailed description
The goal of this study is to determine if sex differences can be identified in the knee joint that can contribute to the differences in incidence and severity of knee osteoarthritis observed in men and women, particularly over the age of 50. Recent studies assessing the responses of articular chondrocytes to systemic factors suggest that there are underlying differences in the biochemical and molecular characteristics of male and female cells. It is also known that immune responses differ in males and females, suggesting that there may be important differences in the levels of immune modulators in the joint tissues, including the synovial membrane, the synovial fluid, and the cartilage itself. Responses to the vitamin D metabolite 1_,25(OH)2D3 are upregulated in osteoarthritic cartilage, raising the possibility that males and females differ in their circulating levels of vitamin D, in the content of vitamin D metabolites in the synovial tissues, or in the ability of the cells to respond to this steroid. Similarly, in post-menopausal women, circulating estrogen is reduced relative to testosterone, but it is not known if this might impact the knee. Most importantly, it is not known if potential sex differences can be correlated with severity of disease.
This study is based on the hypothesis that sex differences exist in different tissues of the knee joint, which contribute to the increased incidence and severity of knee osteoarthritis in older women as compared to older men.
To test this hypothesis, the investigators will use tissues and fluids that are normally discarded during the course of total knee replacement surgery to investigate potential sex differences.
- Conditions
- Degenerative Joint Disease, Osteoarthritis
- Being tested
- musculoskeletal
- Keywords
- Sex differences, knee joint, inflammatory mediators, Vitamin D, osteoarthritis
- Medical subject headings
- Joint Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musculoskeletalOther
Many musculoskeletal conditions are impacted by the chromosomal sex of the patient. While osteoarthritis (OA) is predominant in men younger than 50 years of age, after age 50 the condition is more prevalent in women, particularly post-menopause. This has implications for diagnosis and treatment of OA, as well as for joint replacement.
| Study group | Role | What they receive |
|---|---|---|
| knee osteoarthritis | Many musculoskeletal conditions are impacted by the chromosomal sex of the patient. While osteoarthritis (OA) is predominant in men younger than 50 years of age, after age 50 the condition is more prevalent in women, particularly post-menopause. This has implications for diagnosis and treatment of OA, as well as for joint replacement. Receives: Other: musculoskeletal |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if there are sex-differences in different tissues of the knee joint
- To determine if there are sex-differences in the presence of inflammatory mediators .
- To determine if there are sex-differences in the amounts of vitamin D metabolites,estradiol
- To determine if there are sex-differences in the responses of osteoblasts from the subchondral bone and chondrocytes from the OA lesion metabolites, estradiol or testosterone.
- To determine if there are sex-differences in the content and distribution of neural markers in synovial tissue, menisci and cartilage.
Measured: 1 year
Secondary outcomes (1)
Analyze preoperative functional and clinical data to determine if there are differences in Vitamin D levels and gender differences.
Analyze preoperative functional and clinical data to determine if there are differences in Vitamin D levels and gender differences.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary O'Connor
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Women's Health Research, University of Calgary, Florida State University, Georgia Institute of Technology
- Responsible party
- Sponsor-investigator, Mary O'Connor, Mayo Clinic
- Investigators
- Mary I O'Connor, MD, Principal investigator, Mayo Clinic Jacksonville, Chair, Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403207
- Sponsor's protocol ID
- 11-001468
- Status last verified
- Mar 2014
- First submitted
- 7 Jul 2011
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Potential Sex Differences in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01403207
- Acronym / sponsor ID
- 11-001468
- Conditions
- Degenerative Joint Disease, Osteoarthritis
- Keywords
- Sex differences, knee joint, inflammatory mediators, Vitamin D, osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mary O'ConnorUniversity, hospital or other
- Collaborators
- Society of Women's Health Research, University of Calgary, Florida State University, Georgia Institute of Technology
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Jul 2011 (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 pilot study will use tissues and fluids that are normally discarded during the course of total knee replacement surgery to investigate potential sex differences in knee osteoarthritis. Basic clinical demographic information will be obtained as well as preoperative functional and pain assessment scores, functional tests, and pressure pain threshold measurement. The purpose of the study will be to investigate if any sex differences can be identified in these tissues and to investigate if there appears to be any relationship between these differences and functional scores and tests.
Detailed description
The goal of this study is to determine if sex differences can be identified in the knee joint that can contribute to the differences in incidence and severity of knee osteoarthritis observed in men and women, particularly over the age of 50. Recent studies assessing the responses of articular chondrocytes to systemic factors suggest that there are underlying differences in the biochemical and molecular characteristics of male and female cells. It is also known that immune responses differ in males and females, suggesting that there may be important differences in the levels of immune modulators in the joint tissues, including the synovial membrane, the synovial fluid, and the cartilage itself. Responses to the vitamin D metabolite 1_,25(OH)2D3 are upregulated in osteoarthritic cartilage, raising the possibility that males and females differ in their circulating levels of vitamin D, in the content of vitamin D metabolites in the synovial tissues, or in the ability of the cells to respond to this steroid. Similarly, in post-menopausal women, circulating estrogen is reduced relative to testosterone, but it is not known if this might impact the knee. Most importantly, it is not known if potential sex differences can be correlated with severity of disease.
This study is based on the hypothesis that sex differences exist in different tissues of the knee joint, which contribute to the increased incidence and severity of knee osteoarthritis in older women as compared to older men.
To test this hypothesis, the investigators will use tissues and fluids that are normally discarded during the course of total knee replacement surgery to investigate potential sex differences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| knee osteoarthritis | – | Other: musculoskeletalMany musculoskeletal conditions are impacted by the chromosomal sex of the patient. While osteoarthritis (OA) is predominant in men younger than 50 years of age, after age 50 the condition is more prevalent in women, particularly post-menopause. This has implications for diagnosis and treatment of OA, as well as for joint replacement. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patient enrollment will consist of 10 females and 10 male patients stratified by age. Enrollment is anticipated to be completed over a 12 month time period. Only non Hispanic White patients will be included in the study. Patients must be between 65 and 75 years of age. Patients with a BMI greater than 30 will be excluded
Key inclusion criteria (19 listed)
- 1. Patient demographics (age, sex, BMI). 2. Clinical background material
- Post menopausal female
- List of all medications and supplements
- Prior trauma or knee surgery
- Prior intraarticular injections
Key exclusion criteria (8 listed)
- Patients with inflammatory arthritis
- Patients with osteonecrosis
- Patients with prior upper tibial osteotomy
- Premenopausal women
- Patients under age 65 years, older than 75 years
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 |
|---|---|---|
| musculoskeletalMany musculoskeletal conditions are impacted by the chromosomal sex of the patient. While osteoarthritis (OA) is predominant in men younger than 50 years of age, after age 50 the condition is more prevalent in women, particularly post-menopause. This has implications for diagnosis and treatment of OA, as well as for joint replacement. | Other | knee osteoarthritis |
Primary outcome
To determine if there are sex-differences in different tissues of the knee joint
Time frame: 1 year
1. To determine if there are sex-differences in the presence of inflammatory mediators . 2. To determine if there are sex-differences in the amounts of vitamin D metabolites,estradiol 3. To determine if there are sex-differences in the responses of osteoblasts from the subchondral bone and chondrocytes from the OA lesion metabolites, estradiol or testosterone. 4. To determine if there are sex-differences in the content and distribution of neural markers in synovial tissue, menisci and cartilage.
1 secondary outcome
Analyze preoperative functional and clinical data to determine if there are differences in Vitamin D levels and gender differences.
Time frame: 1 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 14 Mar 2014.
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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.
Mary I O'Connor, MD principal investigator
Mayo Clinic Jacksonville, Chair, Orthopedics
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 Degenerative Joint Disease and Osteoarthritis, run by Mary O'Connor 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 19 inclusion and 8 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 14 Mar 2014. 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?
To determine if there are sex-differences in different tissues of the knee joint (time frame: 1 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 14 Mar 2014.