An Analysis of Potential Sex Differences in Knee Osteoarthritis

NCT01403207 | Completed DMC

• 1 other identifier: 11-001468
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Degenerative Joint Disease; Osteoarthritis

Keywords

Sex differences; knee joint; inflammatory mediators; Vitamin D; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• To determine if there are sex-differences in different tissues of the knee joint

  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 year

Secondary Outcomes (1)

• Analyze preoperative functional and clinical data to determine if there are differences in Vitamin D levels and gender differences.

  1 year

Study Arms (1)

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

Interventions

musculoskeletal OTHER

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.

knee osteoarthritis

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• \. 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mary O'Connor: lead
• Society of Women's Health Research: collaborator
• University of Calgary: collaborator
• Florida State University: collaborator
• Georgia Institute of Technology: collaborator

Study Sites (1)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases

Study Officials

• Mary I O'Connor, MD

  Mayo Clinic Jacksonville, Chair, Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 27, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 14, 2014

Record last verified: 2014-03

Locations

US (1)