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Sponsors and Collaborators: |
University of Calgary DePuy International Johnson & Johnson |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00477360 |
The primary objective of this study is to compare quality of life outcomes in patients who have undergone standard hemiarthroplasty of surgeon's choice, versus those who have undergone a surface replacement hemiarthroplasty.
Condition | Intervention |
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Advanced Glenohumeral Arthritis |
Device: Humeral surface replacement hemiarthroplasty (CAP) Device: Conventional Stemmed Hemiarthroplasty of Surgeon's choice |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Humeral Resurfacing Hemiarthroplasty Versus Conventional Stemmed Hemiarthroplasty: A Canadian Multicentre Randomized Controlled Trial. Phase 1: Pilot Feasibility Study |
Estimated Enrollment: | 75 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
C.A.P
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Device: Humeral surface replacement hemiarthroplasty (CAP)
C.A.P hemiarthroplasty
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2: Active Comparator
Stemmed hemiarthroplasty
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Device: Conventional Stemmed Hemiarthroplasty of Surgeon's choice
Stemmed hemiarthroplasty
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Resurfacing arthroplasty is gaining popularity for the reconstruction of advanced shoulder arthritis. New generation re-surfacing prostheses are engineered to anatomically restore a smooth articulating surface to the humeral head, while preserving bone stock, and potentially minimizing the risk for diaphyseal fracture. However, the current gold-standard for joint replacement is a modular prosthesis with a stem extending into the bony diaphysis of the humerus. Long-term fixation has proven very reliable with these implants. The results for Shoulder Resurfacing prostheses have largely been reported in retrospective reviews and have been very favorable. The purpose of this multi-centered, randomized, controlled trial will be to determine if patient self-assessed outcomes (American Shoulder and Elbow Society (ASES) Score) following humeral resurfacing are superior to those following a conventional, modular, stemmed, humeral prosthesis. The first phase of this study will be a one year pilot recruitment period. This is necessary in order to determine both a center by center, and national recruitment rate, and to determine a sample size necessary for a sufficiently powered full randomized trial. If a full randomized trial is not considered feasible following Phase 1, then a prospective cohort study will be completed.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Pre-Operative Inclusion Criteria:
Pre-Operative Exclusion Criteria:
Intra-Operative Inclusion Criteria:
Intra-Operative Exclusion Criteria:
Contact: Kristie Pletsch | (403) 220-8954 | kdpletsc@ucalgary.ca |
Canada, Alberta | |
University of Calgary Sport Medicine Centre | Recruiting |
Calgary, Alberta, Canada, T2N 1N4 | |
Contact: Kristie Pletsch (403) 220-8954 kdpletsc@ucalgary.ca | |
Principal Investigator: Dr. Richard Boorman | |
Sub-Investigator: Dr. Ian Lo | |
Sub-Investigator: Dr. Robert Hollinshead | |
Sub-Investigator: Dr. Nicholas Mohtadi | |
University of Alberta | Not yet recruiting |
Edmonton, Alberta, Canada, T5H 3V9 | |
Contact: Fiona Styles-Tripp fionastylestripp@cha.ab.ca | |
Sub-Investigator: Dr. Rob Balyk | |
Sub-Investigator: Dr. Jeff Bury | |
Sub-Investigator: Dr. David Sheps | |
Canada, British Columbia | |
Royal Columbian Hosptial | Recruiting |
New Westminister, British Columbia, Canada, V3L 3W7 | |
Contact: Mauri Zomar sfof@direct.ca | |
Sub-Investigator: Dr. Robert McCormack | |
Sub-Investigator: Dr. Farhad Moola | |
Canada, Manitoba | |
Pan Am Medical and Surgical Centre | Not yet recruiting |
Winnipeg, Manitoba, Canada, R3M 3E4 | |
Contact: Jeff Leiter jleiter@panamclinic.com | |
Sub-Investigator: Dr. Peter MacDonald | |
Sub-Investigator: Dr. Jamie Dubberly | |
Canada, Ontario | |
Queens University | Recruiting |
Kingston, Ontario, Canada, K7L 2V7 | |
Contact: Leone Ploeg (613) 548-2432 ploegl@queensu.ca | |
Sub-Investigator: Dr. Davide Bardana | |
Sub-Investigator: Dr. Ryan Bicknell | |
Sub-Investigator: Dr. David Pichora | |
St. Joseph's Health Care - London | Not yet recruiting |
London, Ontario, Canada, N6A 4V2 | |
Contact: Kate Iosipchuk kate.iosipchuk@sjhc.london.on.ca | |
Sub-Investigator: Dr. Darren Drosdowech | |
Sub-Investigator: Dr. Ken Faber | |
Ottawa Hospital | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Kim Bel kibell@ottawahospital.on.ca | |
Sub-Investigator: Dr. Peter Lapner | |
London Health Sciences Centre | Recruiting |
London, Ontario, Canada, N6A5C1 | |
Contact: Sharon Griffin stdshg@uwo.ca | |
Sub-Investigator: Dr. Robert Litchfield |
Principal Investigator: | Dr. Richard Boorman | University of Calgary |
Principal Investigator: | Dr. Dianne Bryant | University of Western Ontario, Canada |
Responsible Party: | University of Calgary ( Dr. Richard Boorman ) |
Study ID Numbers: | 15052007 |
Study First Received: | May 22, 2007 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00477360 |
Health Authority: | Canada: Ethics Review Committee |
Musculoskeletal Diseases Joint Diseases Arthritis |