An Analysis of Potential Sex Differences in Knee Osteoarthritis

This study has been completed.
Sponsor:
Collaborators:
Society of Women's Health Research
University of Calgary
Florida State University
Georgia Institute of Technology
Information provided by (Responsible Party):
Mary O'Connor, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01403207
First received: July 7, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Degenerative Joint Disease
Osteoarthritis
Other: musculoskeletal

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Analysis of Potential Sex Differences in Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To determine if there are sex-differences in different tissues of the knee joint [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Analyze preoperative functional and clinical data to determine if there are differences in Vitamin D levels and gender differences. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Analyze preoperative functional and clinical data to determine if there are differences in Vitamin D levels and gender differences.


Enrollment: 20
Study Start Date: August 2011
Study Completion Date: March 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: musculoskeletal
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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

Criteria

Inclusion Criteria:

1. Patient demographics (age, sex, BMI). 2. Clinical background material

  1. Post menopausal female
  2. List of all medications and supplements

    1. Use of vitamin D supplements (duration and amount)
    2. Use of bisphosphonates (past and current)
    3. Use of estrogen (past and current)
  3. Prior trauma or knee surgery

    1. Have you ever injured the operative knee so badly that it was difficult for you to walk for at least one week?
    2. 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)?
  4. Prior intraarticular injections

    1. Steroid
    2. Hyaluronic acid
  5. SF 12
  6. WOMAC
  7. PASE functional scale
  8. 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
  9. Knee pain map: Patients will complete this within 2 weeks prior to surgery and at 3 months following surgery
  10. 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

a. Vitamin D level 25 D3 should be measured 4. Standard preoperative radiographs: AP, lateral, standing flexion AP and patellar sunrise

Exclusion Criteria:

  1. Patients with inflammatory arthritis
  2. Patients with osteonecrosis
  3. Patients with prior upper tibial osteotomy
  4. Premenopausal women
  5. Patients under age 65 years, older than 75 years
  6. Patients who are insulin dependent or diabetic
  7. Patients with a BMI>30
  8. Patients with a history of knee infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403207

Locations
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mary O'Connor
Society of Women's Health Research
University of Calgary
Florida State University
Georgia Institute of Technology
Investigators
Principal Investigator: Mary I O'Connor, MD Mayo Clinic Jacksonville, Chair, Orthopedics
  More Information

No publications provided

Responsible Party: Mary O'Connor, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01403207     History of Changes
Other Study ID Numbers: 11-001468
Study First Received: July 7, 2011
Last Updated: March 12, 2014
Health Authority: Institutional Review Board: United States

Keywords provided by Mayo Clinic:
Sex differences
knee joint
inflammatory mediators
Vitamin D
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014