RCT Comparing Ion Levels and Clinical Outcomes of A-Class BFH to Metal on Polyethylene Total Hip Replacement

Osteoarthritis Clinical Trial

— RCT  

Official title:

A Prospective Randomized Clinical Trial Comparing Ion Levels and Clinical Outcomes of the CONSERVE® A-Class Total Hip System With BFH® Technology to Metal on Polyethylene Total Hip Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911599
• Other study ID #: 2006-506
• Status: Completed
• Phase: N/A
• Start date: August 2006
• Est. completion date: May 2013

Study information

• Verified date: March 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this prospective randomized controlled trial is to compare the concentrations of metal ions in the blood and urine of patients receiving implants that are identical except for the acetabular component: one is a monoblock and all cobalt chrome, and the other is modular with a titanium acetabular shell with a polyethylene insert.

Description:

The primary aim of this study is to demonstrate that blood ion levels (cobalt and chromium) are lower at one year in patients who receive a metal on polyethylene total hip as compared to CONSERVE® A-Class Total Hip with BFH® technology. Secondary aims include the gathering of clinical data regarding survival and dislocation rates at two years post surgery, as well as the assessment of pain, physical function, radiographic and clinical outcome at the two year interval.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• Individuals undergoing unilateral total hip replacement.

• Patients 50 to 70 years of age.

Exclusion Criteria:

• Patients who have previously undergone any type of joint replacement.

• Patients with evidence of active infection.

• Patients with a documented allergy to cobalt chromium molybdenum.

Related Conditions & MeSH terms

• Arthroplasty
• Hip Joint
• Osteoarthritis

Intervention

Diagnostic Test:
• Blood metal ion levels
Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.

Locations

Country	Name	City	State
Canada	Ottawa Hospital - General Campus	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Wright Medical Technology

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Beaulé PE, Kim PR, Hamdi A, Fazekas A. A prospective metal ion study of large-head metal-on-metal bearing: a matched-pair analysis of hip resurfacing versus total hip replacement. Orthop Clin North Am. 2011 Apr;42(2):251-7, ix. doi: 10.1016/j.ocl.2011.01. — View Citation

Gofton W, Beaule PE. Serum Metal Ions with a Titanium Modular Neck Total Hip Replacement System. J Arthroplasty. 2015 Oct;30(10):1781-6. doi: 10.1016/j.arth.2015.04.040. Epub 2015 May 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metal ion levels	To compare the metal ion levels between the advanced metal system and the traditional metal on polyethylene total hip replacement system.	24 months
Secondary	Dislocation Rate	Radiographic images will be taken to evaluate dislocation rate	24 months
Secondary	Complications	All complications will be continually recorded.	24 months
Secondary	Change in Harris Hip Score	Hip disability will be assessed using the Harris Hip Score. The questionnaire is one of the most commonly used hip scores for assessment of hip function. It comprises of 10 sections: Pain, Support, Limp, Distance walked, Stairs, Public Transportation, Sitting, Putting on Shoes/Socks, Presence of Deformity and Range of Motion (flexion, extension, abduction, adduction, internal and external rotation. The score of these items are summed together to get the total score. Scoring can range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.	24 months
Secondary	Change in RAND-36 Health Survey	Health status will be assessed using the RAND-36 Health Survey. The survey contains eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item referring to a perceived change in health. A high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range. The lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.	24 months
Secondary	Change in UCLA Questionnaire	Patient-reported activity level will be assessed using the UCLA questionnaire. The index is self-administered and assesses current activity level. The UCLA scale is a simple scale ranging from 1 to 10. A low number (1) signifies very low activity levels, whereas 10 signifies a high activity level. One number is selected to best reflect the participants current activity level.	24 months
Secondary	Change in WOMAC Questionnaire	Patient-reported hip functionality will be assessed using the WOMAC questionnaire. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used as a standard assessment of arthritis in the hip joint. The Index is self-administered and assesses the three dimensions of pain (5 items), joint stiffness (2 items), and Physical Function (17 items) in hip osteoarthritis using 24 questions. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. Scores are summed with higher scores indicating worse pain, stiffness, and function.	24 months