Humeral Resurfacing Hemiarthroplasty (CAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Calgary.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
DePuy International
Johnson & Johnson
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00477360
First received: May 22, 2007
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

The primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty.


Condition Intervention
Advanced Glenohumeral Arthritis
Device: Humeral surface replacement hemiarthroplasty (CAP)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • American Shoulder And Elbow Surgeons Shoulder Index (ASES) [ Time Frame: 24 months post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Constant Score [ Time Frame: 24 months post-operative ] [ Designated as safety issue: No ]
  • Western Ontario Osteoarthritis of the Shoulder Index (WOOS) [ Time Frame: 24 months post-operative ] [ Designated as safety issue: No ]
  • Simple Shoulder Test (SST) [ Time Frame: 24 months post-operative ] [ Designated as safety issue: No ]
  • Radiographic Evaluation [ Time Frame: 3 months + yearly post-operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2007
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
C.A.P
Device: Humeral surface replacement hemiarthroplasty (CAP)
C.A.P 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. The results for shoulder resurfacing prostheses have largely been reported in retrospective reviews and have been very favorable. The purpose of this multi-centered, prospective study will be to determine the extent to which patient self-assessed outcomes (American Shoulder and Elbow Society (ASES) Score) following humeral resurfacing improve compared to pre-operative ASES scores.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Alberta
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
DePuy International
Johnson & Johnson
Investigators
Principal Investigator: Dr. Richard Boorman University of Calgary
Principal Investigator: Dr. Dianne Bryant University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Dr. Richard Boorman, University of Calgary
ClinicalTrials.gov Identifier: NCT00477360     History of Changes
Other Study ID Numbers: 15052007
Study First Received: May 22, 2007
Last Updated: August 10, 2011
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 24, 2014