Humeral Resurfacing Hemiarthroplasty (CAP)

August 10, 2011 updated by: University of Calgary

Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary Sport Medicine Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
C.A.P
Device: Humeral surface replacement hemiarthroplasty (CAP)
C.A.P hemiarthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
American Shoulder And Elbow Surgeons Shoulder Index (ASES)
Time Frame: 24 months post-operative
24 months post-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Constant Score
Time Frame: 24 months post-operative
24 months post-operative
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Time Frame: 24 months post-operative
24 months post-operative
Simple Shoulder Test (SST)
Time Frame: 24 months post-operative
24 months post-operative
Radiographic Evaluation
Time Frame: 3 months + yearly post-operative
3 months + yearly post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Johnson & Johnson
DePuy International

Investigators

  • Principal Investigator: Dr. Richard Boorman, University of Calgary
  • Principal Investigator: Dr. Dianne Bryant, Western University, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

May 22, 2007

First Submitted That Met QC Criteria

May 22, 2007

First Posted (Estimate)

May 23, 2007

Study Record Updates

Last Update Posted (Estimate)

August 11, 2011

Last Update Submitted That Met QC Criteria

August 10, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15052007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Glenohumeral Arthritis

Clinical Trials on Humeral surface replacement hemiarthroplasty (CAP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe