Status:
COMPLETED
An Analysis of Potential Sex Differences in Knee Osteoarthritis
Lead Sponsor:
Mary O'Connor
Collaborating Sponsors:
Society of Women's Health Research
University of Calgary
Conditions:
Degenerative Joint Disease
Osteoarthritis
Eligibility:
All Genders
65-75 years
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 clin...
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 an...
Eligibility Criteria
Inclusion
- 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)
- 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
- a. Vitamin D level 25 D3 should be measured 4. Standard preoperative radiographs: AP, lateral, standing flexion AP and patellar sunrise
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01403207
Start Date
August 1 2011
End Date
March 1 2014
Last Update
March 14 2014
Active Locations (1)
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1
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224