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Humeral Resurfacing Hemiarthroplasty Versus Conventional Stemmed Hemiarthroplasty

This study is currently recruiting participants.
Verified by University of Calgary, August 2008

Sponsors and Collaborators: University of Calgary
DePuy Canada
Johnson & Johnson
Information provided by: University of Calgary
ClinicalTrials.gov Identifier: NCT00477360
  Purpose

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
Advanced Glenohumeral Arthritis
Device: Humeral surface replacement hemiarthroplasty (CAP)
Device: Conventional Stemmed Hemiarthroplasty of Surgeon's choice

U.S. FDA Resources

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

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • American Shoulder And Elbow Surgeons Shoulder Index (ASES) [ Time Frame: 12 months post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Constant Score [ Time Frame: 12 months post-operative ] [ Designated as safety issue: No ]
  • Western Ontario Osteoarthritis of the Shoulder Index (WOOS) [ Time Frame: 12 months post-operative ] [ Designated as safety issue: No ]
  • Simple Shoulder Test (SST) [ Time Frame: 12 months post-operative ] [ Designated as safety issue: No ]
  • Radiographic Evaluation [ Time Frame: 12 months post-operative ] [ Designated as safety issue: No ]
  • Early post-operative pain [ Time Frame: 6 weeks post-operative ] [ Designated as safety issue: No ]

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
1: Experimental
C.A.P
Device: Humeral surface replacement hemiarthroplasty (CAP)
C.A.P hemiarthroplasty
2: Active Comparator
Stemmed hemiarthroplasty
Device: Conventional Stemmed Hemiarthroplasty of Surgeon's choice
Stemmed hemiarthroplasty

Detailed Description:

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Pre-Operative Inclusion Criteria:

  • Failed standard non-surgical management (analgesics, nsaids, physiotherapy, activity modification)
  • Persistent pain and disability for at least 6 months
  • Imaging demonstrates advanced humeral head cartilage loss

Pre-Operative Exclusion Criteria:

  • Active or systemic joint infection
  • Significant muscle paralysis of shoulder girdle
  • Charcot's Arthropathy
  • Major medical illness (life expectancy <2years)
  • Unable to speak and read English/French
  • Psychiatric illness that precludes informed consent
  • Unwilling/unable to remain in study for one year

Intra-Operative Inclusion Criteria:

  • Advanced humeral head cartilage loss AND ONE of:
  • minimal/no glenoid cartilage loss
  • complete glenoid cartilage loss and no bony erosion
  • complete glenoid cartilage loss and concentric bony erosion with no humeral anterior/posterior subluxation

Intra-Operative Exclusion Criteria:

  • Eccentric glenoid erosion with biconcavity of glenoid and subluxation of humeral head
  • Inability of humeral head to support the CAP surface replacement
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477360

Contacts
Contact: Kristie Pletsch     (403) 220-8954     kdpletsc@ucalgary.ca    

Locations
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            

Sponsors and Collaborators
University of Calgary
DePuy Canada
Johnson & Johnson

Investigators
Principal Investigator:     Dr. Richard Boorman     University of Calgary    
Principal Investigator:     Dr. Dianne Bryant     University of Western Ontario, Canada    
  More Information


Responsible Party:   University of Calgary ( Dr. Richard Boorman )
Study ID Numbers:   15052007
First Received:   May 22, 2007
Last Updated:   August 20, 2008
ClinicalTrials.gov Identifier:   NCT00477360
Health Authority:   Canada: Ethics Review Committee

Study placed in the following topic categories:
Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on October 10, 2008




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