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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Arthroplasty; Hip Joint
• Intervention / Treatment: Diagnostic test: Blood metal ion levels

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital - General Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conserve Total Hip with BFH; CONSERVE® A-Class Total Hip with BFH technology. Blood and urine samples will be collected and blood metal ion levels will be analyzed and compared to samples from the other group.	Diagnostic test: Blood metal ion levels; Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.
Active Comparator: Metal with Polyethylene Liner; Metal on polyethylene total hip replacement. Blood and urine samples will be collected and blood metal ion levels will be analyzed and compared to samples from the other group.	Diagnostic test: Blood metal ion levels; Blood and urine will be collected and the levels of cobalt and chromium ions will be tested.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dislocation Rate	Radiographic images will be taken to evaluate dislocation rate	24 months
Complications	All complications will be continually recorded.	24 months
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
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
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
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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Stryker Trauma GmbH

Publications and helpful links

General Publications

• Beaule 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.2011.01.005.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2006
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 29, 2009
• First Submitted That Met QC Criteria: June 1, 2009
• First Posted (Estimate): June 2, 2009

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Individuals undergoing unilateral total hip replacement.
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2006-506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No